Unither Pharma, Inc.

Text (OCR of the scan at left; may contain errors)

IN THE MATTER OF UNITHER PHARMA, INC., ET AL.

CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND SEC. 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-4089; File No. 0223036 Complaint, July 22, 2003--Decision, July 22, 2003 This consent order, among other things, prohibits Respondents Unither Pharma, Inc. and United Therapeutics Corporation – which market HeartBar products, chewy food bars and powders enriched with L-Arginine, vitamins, and minerals – from representing that HeartBar (HeartBar, HeartBar Plus, or HeartBar Sport), or any other L-Arginine product used in or marketed for the treatment, cure, or prevention of cardiovascular disease, or the improvement of cardiovascular or vascular function (1) substantially decreases leg pain for people with cardiovascular disease; (2) reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, estrogen deficiency, or any other medical condition or health risk; (3) prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, or reduces the risk of developing cardiovascular disease; (4) reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, or for medications, such as nitroglycerin, in patients with cardiovascular disease; or (5) improves endurance, circulation, and energy for the general population, unless the claims are substantiated by competent and reliable scientific evidence. The order also requires the respondents to possess competent and reliable scientific evidence to support any future claims about the health benefits, performance, or efficacy of any food, medical food, or dietary supplement used in or marketed for (1) the treatment, cure, or prevention of cardiovascular disease, or (2) the improvement of cardiovascular or vascular function. In addition, the order prohibits the respondents from misrepresenting, with respect to the above products, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. The order also requires the respondents notify their distributors as to the claims the Commission has challenged and report to the Commission any distributors who continue to make claims that the Commission’s order prohibits. Participants For the Commission: Matthew Daynard, Keith Fentonmiller, Mary K. Engle and Dennis Murphy.

For the Respondents: Daniel Ferrel McInnis, Akin, Gump, Strauss, Hauer & Feld L.L.P.

VOLUME 136 Complaint COMPLAINT The Federal Trade Commission, having reason to believe that Unither Pharma, Inc., a corporation, and United Therapeutics Corporation, a corporation, have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges: 1. a. Respondent Unither Pharma, Inc. (“Unither Pharma”) is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910. Unither Pharma is a wholly owned subsidiary of Unither Pharmaceuticals, Inc., which is wholly owned by respondent United Therapeutics Corporation. Unither Pharma markets and sells an L-argininebased dietary supplement and a purported medical food under the HeartBar brand name. This dietary supplement purportedly treats or prevents cardiovascular disease and/or improves endurance. b. Respondent United Therapeutics Corporation (“United Therapeutics”) is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910. United Therapeutics participated in the advertising claims challenged herein, including the creation and dissemination of Exhibits H through J.

2. Respondents have advertised, offered for sale, sold and distributed products to the public, including HeartBar, HeartBar Plus, and HeartBar Sport. These products are “foods” and/or “drugs” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

3. The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. VOLUME 136 Complaint 4 Respondents have disseminated or have caused to be disseminated advertisements for HeartBar and HeartBar Plus (collectively “HeartBar”) and HeartBar Sport, including but not necessarily limited to the attached Exhibits A through J. Since at least 1999, advertisements and promotions have appeared on the cookepharma.com and unither.com websites, on product packaging, and/or in print media, such as Reader’s Digest, Modern Maturity, Prevention, The San Francisco Chronicle, The Chicago Sun-Times, The Detroit Free Press, The Cleveland Plain Dealer, The Miami Herald, and newspaper inserts published by News America Marketing FSI, Inc. HeartBar products are sold in two forms, an edible bar and a powder, which is mixed with water. The bars have sold for approximately $2 each. According to the product labels, HeartBar and HeartBar Sport contain, among other ingredients, 3 to 6 grams of L-Arginine, soy isoflavones extract, Vitamins A, B-6, B-12, C and E, niacin, folate, iron, and calcium. The advertisements for HeartBar contain the following statements, among others: Print Advertising:

A. Today people with heart disease are discovering that taking two HeartBars a day is bringing welcome relief from heart disease symptoms such as … leg pain - usually within the first two weeks.

One HeartBar a day thereafter may be sufficient to maintain results. … Studies show that taking two HeartBars a day … * * * * Reduce[s] painful symptoms such as angina and leg pain * * * * (Ex. A) (Ex. A is a print advertisement for HeartBar). B. Here’s what HeartBar can do… Improve … heart health * * * * VOLUME 136 Complaint Reduce painful symptoms such as … leg pain * * * * (Ex. B) (Ex. B is a print advertisement for HeartBar). Internet Advertising:

C. HeartBar® Plus contains 6 grams of arginine per serving, and it has been shown in clinical trials to be effective in ... decreasing angina ... in patients with coronary artery disease. In addition, HeartBar® Plus may be of benefit to selected at-risk population of developing cardiovascular disease.

(Ex. C at 1) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002). D. Eating two HeartBars a day …:

• Reduces painful symptoms of heart disease such as … leg pain * * * * • Helps improve ability to exercise without pain, discomfort… * * * * Results are usually experienced within the first two weeks. After two weeks, one HeartBar® may be sufficient to maintain results.

(Ex. D at 1) (Ex. D consists of webpages from the cookepharma.com website dated August 20, 2001). E. …Not to be mistaken for health bar look-alikes, new HeartBar® contains a scientifically proven ingredient to reduce the pain … associated with vascular disease … . * * * * Fifteen years of scientific research at major institutions reveal that in certain patients the dietary use of the nutritional ingredients in HeartBar®:

Helps reverse the effects of high cholesterol, smoking, • diabetes, and estrogen deficiency on the heart VOLUME 136 Complaint * * * * (Ex. C at 5-6) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002). F. How does HeartBar® Work? … The active ingredients in HeartBar® have been clinically proven, in properly selected patients, to … increase pain-free exercise performance. (Ex. C at 7) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002). G. How many HeartBars should a consumer eat a day to receive all of the heart and vascular benefits? Clinical research shows that, for best results, … significant improvement (66%) in pain free walking distance … [is] achieved by eating two bars a day.

(Ex. D at 2) (Ex. D consists of webpages from the cookepharma.com website dated August 20, 2001). H. HeartBar Sport is a line of L-arginine dietary supplements developed from our experience with HeartBar Plus. HeartBar Sport contains 3 grams of arginine per serving, and it has been shown in clinical trials to improve endurance and energy.

(Ex. C at 3) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002). I. Who are HeartBar® products for? * * * * HeartBar® Sport, the dietary supplement, is intended for older adults or at-risk individuals who wish to maintain good cardiovascular health, as well as benefit from increased energy and endurance.

VOLUME 136 Complaint (Ex. C at 14-15) (Exhibit F consists of webpages from the cookepharma.com website dated March 26, 2002). J. The following testimonials from doctors have appeared on the cookepharma.com website:

1. Doctor’s Corner ___________________________________ John P. Cooke Vascular Medicine Stanford University School of Medicine Stanford, CA A Nutritional Approach to a Healthy Endothelium:Case Histories I have been studying the endothelium for the better part of two decades, first at Mayo where I was trained, then as an Assistant Professor at Harvard, and now as Associate Professor and Director of the NIH-funded Vascular Medicine Program at Stanford. … The HeartBar® has now been tested in rigorous, doubleblind, placebo-controlled trials and has been shown to improve exercise tolerance and reduce pain in patients with coronary and peripheral arterial disease. Although these clinical trials are very gratifying, what I find even more satisfying are the positive results that I have observed in my own clinic. Here are a few representative anecdotes:

* * * * A 78 y/o male with intermittent claudication L. M. is a vigorous 78 year old man who looks younger than his stated age. As an alpine biologist, one of his classes each year involved a month of hiking over the VOLUME 136 Complaint heights of Yosemite and King's Canyon. Now, in retirement he is still an outdoorsman, and enjoys outdoor activities with his son.

For the last few years though, he had noticed cramping in his legs after walking up a hill. The discomfort would subside if he stood still for a moment, and then he could go on. But about two years ago, the cramping became a real disability for him. He was tightening up after walking a half-mile, and he could only go that far if he walked slowly. The great outdoors was getting farther away for LM.

He came to my Vascular Medicine clinic at Stanford in the spring of 1999. I prescribed Trental 400 tid. He returned to me 6 weeks later with little improvement. At that point I stopped the Trental and introduced him to the HeartBar. LM began taking two bars daily. It wasn't long before he noticed an improvement, and over time, he continued to improve. At the time of this writing, LM is able to walk faster, without pain, and considers himself unlimited. He is even able to jog a quarter of a mile before he needs to slow down. He's back to the hills, and enjoying the outdoors again with his son.

I hope that you found these anecdotes interesting. I welcome you to send in your own anecdotes regarding your experience with this nutritional therapy. With warmest regards, John P. Cooke, MD Ph.D.

Associate Professor and Director Section of Vascular Medicine Stanford University School of Medicine ____________________________________ 2. Doctor’s Corner ____________________________________ VOLUME 136 Complaint Alan S. Bailer Cardiovascular Diseases 1330 Cottman Ave.

Philadelphia, PA 19111 Patient Success Story My 77 year old father had a triple coronary artery bypass grafting procedure in 1984. … * * * * I am convinced that, without the HeartBars, my father would have had to undergo another revascularization. Thank you, Cooke Pharma, for this wonderful product. ____________________________________ 3. Doctor’s Corner ____________________________________ Marcus S. Kryger Box 280 Forsyth, MO 65653 PVD Patient Success Stories • 82 Year old white female with ischemic cardiomyopathy and severe peripheral vascular disease by IMEX scan. Unable to walk 1 block due to leg pain and dyspnea. She was scheduled for femoral artery bypass, but started on HeartBar. Three months later, without surgery or other medical changes, she was walking 2 miles daily and continues to do so, without symptoms, 15 months later.

VOLUME 136 Complaint * * * * • 86 Year old white male with CHF due to ischemic cardiomyopathy and severe leg pain on walking over 50 feet. Started on HeartBar BID, no other changes in medical regime. A month later he repaired his roof by himself without any symptoms. He felt well for 4 months then stopped HeartBar. He rapidly became more dyspneic; restarted HeartBar BID with prompt improvement and went deer hunting this past fall.

____________________________________ 4. Doctor’s Corner ____________________________________ Peter Gray 90 South St.

Glens Falls, NY 12801 Great Results--Reducing Angina Episodes, Claudication… Great results regarding:

* * * * • Reducing claudication.

I'm now using it with my father for claudication with excellent results.

____________________________________ (Ex. C at 8-13) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002). K. The following testimonials from HeartBar customers have appeared on the cookepharma.com website: VOLUME 136 Complaint 1. Mary R. Gompf from OH “It was just like my Doctor said. After only 2 weeks of taking the HeartBar, I noticed a dramatic reduction in my … leg pain. …Thank you.”

2. Mr. Barry Dangler from FL “…My Cardiologist has taken me off of Imdur for my angina pain now that I'm taking the HeartBar. I feel great.” 3. Ms. Betty Burke from CA “I had severe burning pain in my left leg when I ran up hills. My AB Index, done by Stanford Research, in my left leg was only .5. I read on the Internet that a .4 Index might require amputation. After 2 weeks taking the HeartBar, the burning pain is gone! I can run with no pain. I also don't have any leg pain when playing tennis. I was seen by a vascular surgeon who proclaimed that I had excellent circulation in both legs. HeartBar has really changed my life!”

4. Mr. Sam Roska from CA “I have atherosclerosis in both legs. After 2 angioplasties on my legs, my doctor put me on HeartBar. Further angioplasty presented a 20% risk of amputation. I had been able to walk only up to about 3 minutes before debilitating leg pain forced me to stop. After about a month on the HeartBar, I was able to walk 10 minutes with no pain! I now have much less pain than before.” 5. Thomas Overbeek from MI “I have had leg pains for about 10 years. The pain in my left leg became especially bad in the last 6 months. I could barely walk from the bedroom to the bathroom. I couldn’t stand up without pain. Because of my worsening VOLUME 136 Complaint condition, I was scheduled for bypass surgery in my leg. My doctor told me my pain would remain, however. But, after 2 weeks taking the HeartBar, the pain in my leg disappeared. It was unbelievable! As scheduled, I went into see my surgeon the day before my surgery; he cancelled the surgery. I haven’t felt this good in 10 years. I can walk and climb stairs with no pain now, and can stand for half an hour. …”

6. Al White from MI “I am almost an Octogenarian (in 6 months)…. I have not had to use my Nitro-Stat pills since I started using HeartBars—not a single one. I got my Doctor’s OK first to use the HeartBars.”

(Ex. C at 16-18) (Exhibit F consists of webpages from the cookepharma.com website dated March 26, 2002). Packaging:

L. Front panel:

HeartBar Plus 6g L-Arginine per Bar Clinically Proven Results * * * * VOLUME 136 Complaint Reduces angina and leg pain (Ex. C at 2) (Ex. C consists of webpages from the cookepharma.com website dated March 26, 2002; page 2 depicts packaging for HeartBar Plus).

M. Front panel:

HeartBar * * * * Recommended by Doctors for Daily Use * * * * • Helps Reduce… Leg Pain * * * * Back panel:

If you have heart disease, take two HeartBars a day to feel a difference within two weeks.

Eating two HeartBars a day helps … with the following results:

VOLUME 136 Complaint • Reduces painful symptoms of heart disease such as … leg pain

• Helps improve ability to exercise without pain, discomfort …

(Ex. E at 1-2; citation omitted) (Ex. E is a copy of the packaging for HeartBar).

N. Front Panel:

HeartBar Sport Dietary Supplement 3g L-Arginine per Serving Clinically Proven Results Improves endurance… and energy[] (Ex. F; citation omitted) (Ex. F is a copy of the front of the packaging for HeartBar Sport from 2002). VOLUME 136 Complaint Other Promotions:

O. Is HeartBar® Right for You? * * * * If you are elderly, you might want to consider that as we age, our need for arginine in the diet increases. Eaten in the right amount, arginine can help prevent a variety of agerelated vascular problems, including “hardening of the arteries” and plaque formation, and prevent or reverse the symptoms associated with them. … (Ex. G at 2) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

P. …[E]ating HeartBar® products … can improve your aerobic performance. For these reasons, even those who are not experiencing heart disease or age-related symptoms choose to make HeartBar® part of their daily regimen. Clinical Research Confirms that HeartBar® … * * * * Relieves painful symptoms such as angina and leg pain. * * * * (Ex. G at 3) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

VOLUME 136 Complaint Q. See Results in Two Weeks! In clinical studies, after only two weeks of eating two HeartBars® daily, patients showed significant improvement in angina scores ....[] In patients suffering from PAD (peripheral artery disease), HeartBar® was shown to significantly improve the ability to walk pain free.[] After the initial two weeks, one HeartBar® a day may be sufficient to maintain these results.

* * * * 70% reduction in angina pain 66% increase in ability to exercise (Ex. G at 4; citations omitted) (Ex. G is an excerpt from the jewel case insert for The Heart of the Classics musical Compact Disc given to HeartBar distributors).

R. “In my experience, recommending Heart Bar has helped to stop heart disease in my patients.” Joe Predergast, M.D.

Diabetes Specialist (Ex. H. at 2; Ex. K is an excerpt from the 2001 United Therapeutics Corporation Annual Report). S. HeartBar … Clinical studies conducted by Cooke Pharma have VOLUME 136 Complaint demonstrated the ability of the HeartBar to reduce painful symptoms associated with cardiovascular diseases …. Randomized, double-blinded clinical studies published in medical journals and presented at the 2000 American Heart Association meeting have shown that the HeartBar works. … (Ex. I. at 2; Ex. I is an excerpt from the 2000 United Therapeutics Corporation Annual Report). T. United Therapeutics Acquiring Cooke Pharma, Expanding into Angina and Coronary Artery Disease Silver Spring, MD and Belmont, CA, December 18, 2000 – * * * * …Clinical studies conducted by Cooke Pharma have demonstrated convincingly the ability of the HeartBar to reduce painful symptoms of cardiovascular disease…. … (Ex. J at 1; Ex. J is a December 18, 2000, press release from the unitedtherapeutics.com website). 5. Through the means described in Paragraph 4, respondents have represented, expressly or by implication, that: A. HeartBar substantially decreases leg pain for people with cardiovascular disease;

VOLUME 136 Complaint B. HeartBar reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, or estrogen deficiency;

C. HeartBar prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, and reduces the risk of developing cardiovascular disease;

D. HeartBar reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, and medications, such as nitroglycerin, in patients with cardiovascular disease; and E. HeartBar Sport improves endurance and energy for the general population.

6. Through the means described in Paragraph 4, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 5, at the time the representations were made.

7. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 5, at the time the representations were made. Several of the representations are not supported by any clinical studies on humans. Other representations are based on results reported in studies that suffer from various flaws, including the failure to account for the placebo effect and extremely small sample sizes, such that the experience of a single or a few subjects account for the benefits purportedly experienced by the active group as a whole. Therefore, the representation set forth in Paragraph 6 was, and is, false or misleading.

VOLUME 136 Complaint 8. Through the means described in Paragraph 4, respondents have represented, expressly or by implication, that clinical studies, research, and/or trials show that:

A. HeartBar decreases angina pain, including by as much as 70% within two weeks;

B. HeartBar decreases leg pain while walking or exercising, including by as much as 66% within two weeks, for people with peripheral artery disease;

C. HeartBar reverses the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart; and D. HeartBar Sport improves endurance and energy for the general population.

9. In truth and in fact, clinical studies, research, and/or trials do not show that:

A. HeartBar decreases angina pain, including by as much as 70% within two weeks;

B. HeartBar decreases leg pain while walking or exercising, including by as much as 66% within two weeks, for people with peripheral artery disease;

C. HeartBar reverses the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart; or D. HeartBar Sport improves endurance and energy for the general population.

Therefore, respondents’ representations set forth in Paragraph 8, above, were, and are, false or misleading. 10. The acts and practices of respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

VOLUME 136 Complaint THEREFORE, the Federal Trade Commission this twentysecond day of July, 2003, has issued this complaint against respondents.

By the Commission.

FREE Help for Heart Disease Sufferers | Get one HeartBar* FREE for EVERY HeartBar You minis Or save $10. 00. ona 16- bar carton.

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For more Isformatios about Heartiiar or to order directty from us, cal . tod free (B88) 808-6838 o visit cw website zt wern.cookepharma.com. . d Use sader the supervision of a physician. Ask your pharmacist. Kd Today people with heart disease are discovering that taking two HeartBars a day is bringing welcome relief from heart disease symptoms such as fatigue, chest pain, and leg pain - usually within the first two weeks.- One HeartBar a day thereafter may be sufficient to What people are saying maintain results. about HeartBar... HeartBar’s exclusive formula i is based on the science “1 haven't felt thi din 10 F _| that won the 1998 Nobel prize in medicine. It is the walk and cli b IS good in 10 years. | can result of ten years of clinical research at America’s M he rie an with no pain now... leading medical institutions. Studies show that taking to, energy level is also up and | can't wait two HeartBars.a day helps open blood vessels and get out and do things.” - Thomas O., MI improves circulation to: “After taking two HeartBars a day for two Help you feel more active and energetic weeks, the discomfort in my chest is gone... I'm not afraid to walk alone any more. It’s V Reduce painful symptoms such as angina sensational! I'm full of energy.” - Mary S., PA and leg pain “Several months ago, | was introduced to V Improve your tolerance for activity, so you can HeartBars by my cardiologist. | am convinced do more of the things you’ve always enjoyed that this product has greatly improved my If you have heart disease or a family history of heart quality of life.” - Mary Ann D., CA disease, ask your doctor about HeartBar, the only Visit our web site at www.cookepharma.com medical food for the dietary management of heart and to read what more people are saying. vascular disease. And use the valuable coupons below to try HeartBar and feel the difference for yourself. Available at these and other fine pharmacies: CVSiormery § OpceDryg Sreoncrug | A\Anersons Recommended by thousands your on ee one; Wena of cardiologists for relief ur phart. run le ani ’ (of this free offer, you can purchase HeanBar ciety from us 1) By cling of heart disease symptoms. toll-free: 1-888-808-6838 2) By visiting our web site at www.cookepharma.com, ee eM ee ri ae ad r [ MANUFACTURER COUPON | EXPIRATION DATE 063001 | T [TWANUFACTURER COUPON | Soriano basal | 7 | FREE HeartBar’ | SAVE $10.00 Get one HeartBar FREE for EVERY HeartBar you buy! On a 16-bar carton of HeartBar*! FP HeartBar” aera Guat te wer pet ob © pte O pete 63535 ll $s 2)03 22 (NM Milk Geet Pe ese pe ot © pete 6 eh . wo ow ow oe ee ee If you have heart disease or are at risk for heart disease... ; Free HeartBar’ Samples! Call 1-888-808-6858.

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__ If any of these describe you...

v Diagnosed with heart disease. Delicious new choices v High blood pressure * New low-calorie HeartBar Orange Drink mix wv Smoker (only 40 calories per serving) v Estrogen deficiency ¢ New great tasting HeartBar flavors y High cholesterol, es v Weight problem (obesity) HO} Bar; :

vy Diabetes © = - peereren hs 7a v Family history of heart disease . _ Hagia ts Here’s what HeartBar can do... .

v Improve circulation and heart health Convenient: : v Help you feel more active and energetic home delivery Se sires v Reduce painful symptoms such as angina and leg pain © To order, simply call the toll-free . v improve your stamina, so that you can do more of the number below or visit our web site (A ; . things you've always enjoyed, _ Bt wwwheartbarnet. f— © Your order sent via Priority Mail Based on Nobel Prize winning science © This is now the easiest and only way to get HeartBar _ © Exclusive, patented formula based on the science that won the 1998 Nobel Prize in medicine -- ~for-your free. samples, ~. © The result of 15 years of clinical research at America's to order HeartBar, or talk with a leading medical institutions HeartBar Counselor, call toll-free: ¢ The only medical food for the dietary management of heart and vascular disease 1 -888-808-6838 ° Recommended by thousands of cardiologists Or visit our web site at www.heartbar.net Answering America’s call for improved heart health nme NreR NET Oe tee (rate MPPs moma mee een ante oar Leet Mis sey rea Ns ee ohne ree Puce t eter tet vee Unither Pharm:

Unither Pharma “Fleatth for « New Generation HeartBar® Products @ Medical Food # Dietary Supplement % Or ! Company Information @ About Unither Pharma Sd iff @ Contact Science Library ° Definition of Terms Doctor's Corner Frequently Asked Questions @ Testimonials @ MD Mentors Locator Customer's Corner # Frequently Asked Questions # Testimonials A United Therapeutics Corporation Company a - HeartBar® Plus, Medical Foods HeartBar® Plus - Medical Food The HeartBar® Plus Product Line - Six Delicious Flavored Bars and an Orange- Flavored Powdered-Drink.

‘HeartBar® Plus is a line of L-arginine-based medical foods, clinically proven to be safe and effective in the dietary management of people with or at risk of developing. cardiovaqscular disease. it is the first medical food to be listed in the Physician's Desk Reference.

HeartBar® Plus contains 6 grams of arginine per serving, and it has been shown in clinical trials to be effective in enhancing exercise capacity while decreasing angina while improving the quality of life in patients with coronary artery disease. In addition, HeartBar® Plus may be of benefit to selected at-risk population of developing cardiovascular disease.

Normal dietary sources of L-arginine include nuts, red meat, and seafood; they are usually high in fat content, not desirable for daily consumption by patients with heart disease. HeartBar® Plus is a convenient dietary source of L-arginine, suitable for daily consumption. For example, a single serving of HeartBar® Plus contains 6 9 of L-arginine, which is equivalent to consuming three steaks, or two lobsters, OF twelve 500 mg or re Page 1 of 2 ah ».

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Cardiovascular disease is a serious condition. Patients should not undertake any type of self-diagnoses or self-treatment without the active supervision of a physician. Heartbar® Plus is a medical food, not a conventional food, and is intended for use by patients who are under the care of a physician. SRO RPA, Wn dav unre o, ; : “ao “ es SA OX Meviowl Fox hon Cad for de Bicty ielayy Mouggenicy CHicatt ond ise si tsa stds _Oisinalvanitia ay GAT Ei qt9 1) 93; os _— a MENT Sin gay if you have any questions, please feel free to contact us. Ali Rights Reserved, Unither Pharma 2001, 2002 Page 2 of 2 sere were! ~ AS rate ceee + eee Peete bee Unither Pharma - Heartbar® Sport, Dietary Supplements Unither Pharma Health for a New Generation HeartBar® Products @ About HeartBar® Ingredients/Nutritions # Medical Food @ Dietary Supplement “® Order HeartBar Products Company Information @ About Unither Pharma # Scientific Advisory Board ® Contact Science Library Doctor's Corner @ Frequently Asked Questions @ Testimonials @ MD Mentors Locator Customer's Corner @ Frequently Asked Questions + Testimonials A United Therapeutics Corporation Company pat aor! The HeartBar Sport® Product Line - Six Delicious Flavored Bars and an Orange-Flavored Powdered-Drink.

HeartBar Sport is a line of L-arginine dietary supplements developed from our experience with HeartBar Plus. HeartBar ~ Sport contains 3 grams of arginine per serving, and it has been shown in clinical trials to improve endurance and energy. Millions of Americans are looking for ways to remain fit and healthy for their entire lifetime, and age should not be a barrier to living a full and productive life. Adding HeartBar Sport to your diet may help you lead a more active lifestyle. Page 1 of 2 soma ar et . ; cos ‘| Unither Pharma - Heartbar® Sport, Dietary Supplements Page 2 of 2 oe) ; {uu If you have any questions, please feel free to contact us. : All Rights Qeserved, Unither Pharma 2001, 2002 lates Thenine eantbanharma enm/hhGnart asn 3/26/2002 seem sme enarer oe ae Semen st eee nem ements seen Men eeee weet et eee tie tam ee Letter ie ALES FRM EE TET ST oe Unither Pharma - Science Library (About Heart Diseases) hot dogs, fatty red meats e butter, egg yolks, and cheese e organ meats like”

liver, sweetbreads, kidney, and brain e whole milk, cream, margarine, and lard baked goods made with egg yolks and saturated fats saturated olls like coconut, palm, and palm kernel oil and ice cream fried foods ____.

—— Certain vitamins have been shown to be beneficial when included ‘in a healthy diet. Antioxidants which are found in vegetables and fruit may reduce the chance of having a heart attack. They work by preventing the damaging effects of free radicals, which can damage cells and cause cholesterol buildup. Niacin, when taken in high doses, lowers triglycerides (fat) and cholesterol as it raises the levels of high-density lipoprotein (HDL). HDL attach themselves to excess cholesterol in the lining of the blood vessels and pass it out of the body. Finally, there’s folic acid. This lowers homocysteine (an amino acid) levels in the blood, which may be a vitamin B12. ‘ , Heart Bar™ raises the bar on the dietary management of cardiovascular disease HeartBar@ is the first medical food intended for the dietary management of cardiovascular disease. The US Food and Drug Administration (FDA) has defined a medical food as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” [21 U.S.C. §. 360ee(b)(3)}. It is intended for use under the supervision of a physician. , ‘While this new category of dietary management of cardiovascular disease is very exciting to the medical community, the specifics about new HeartBar® are even more so. Not to be mistaken for haalth har lank-alikas naw HeaartRar® enntains a sciantifically Page 6 of 8 eee * Se eter avatars AO Rae ste te ATEN eT BOARD par stereo Lee wer eysun' Pg meant A IN Stet scene tare ee Oat em tenet wer ee ee ey Unither Pharma - Science Library (About Heart Diseases) _ CU e eee mete CN rte EOD RIE, BENT OE 8 FUEL BE ERD Nw We cRUn EE tee we mr tvnnrE senestrnees proven ingredient to reduce the pain and fatigue associated with vascular disease, helping patients feel better and become more active after only 2 weeks. How can new HeartBar® do all that? Here's how: :

HeartBar® contains a patented formulation designed to increase the body's production of nitric oxide. Research has shown that many patients with heart disease have deficient levels of nitric oxide. The body uses nitric oxide to dilate or widen the blood vessels and allow blood to flow more freely. Nitric oxide also helps prevent cholesterol and platelets from sticking to the blood vessels’ walls, which would further inhibit free blood flow. Fifteen years of scientific research at major institutions reveal that in certain patients the dietary use of the nutritional ingredients in - HeartBar®:

e Helps reverse the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart | e Promotes better circulation for better heart health e Restores blood vessel function for those at risk for or with heart disease Daily use of this chewy, delicious HeartBar® may be able to help you take a bite out of the painful and life-limiting symptoms. of cardiovascular disease. Patients may also benefit from its many other nutrients, which include antioxidants like [such as] vitamins C, E, B6, and B12, as well as potassium, folic acid, niacin, and fiber.

Ask your doctor whether adding HeartBar® to your diet can raise the bar for your cardiovascular health. if you have any questions or want more information about cardiovascular health, talk with your doctor or health care professional. This general information on cardiovascular disease presented was adapted from information presented by the American Heart Association (AHA) and American Dietetic Association (ADA).

Page 7 of 8 :

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tt Smewtmwenmmee se mem ane mneS S veeerarreme no see ie ee tt seer see meee sete eM eeetaag ae dete rn. Src ot ta — nearer eA IA ten Unither Pharma - Frequently Asked Questions for Doctors their arginine from red meats, which is not a desirable -source of L-arginine.

[back to top] How does HeartBar® Work? HeartBar® is based on a unique biological marker (indicator). Rather than using high cholesterol as a biological] marker of the development of atherosclerosis, Unither has developed a new approach measuring the endothelial production of nitric oxide. Endothelial nitric oxide production is often reduced in people with cardiovascular and peripheral arterial disease as well as those with risk factors for these diseases. The active ingredients in HeartBar® have been Clinically proven, in properly selected patients, to restore nitric oxide production, improve vascular function and increase painfree exercise performance. HeartBar® Plus, the medical’ food, is intended for use under the supervision of a , physician.

[back to top] Why can't patients just take an L-arginine pill? Heart disease patients and healthy individuals CAN take arginine supplement pills, but taking arginine pills are not as convenient as taking a single serving of the deliciously-flavored HeartBar® product. For example, arginine pills usually contain 500 to 750 mg of L-arginine, and a single serving of HeartBar® Plus contains as much L-arginine as twelve 500 mg arginine pills (see table below.) As you can see, HeartBar® products are a more convenient supplemental dietary source of L-arginine. I t HeacdtRan® Sant 1 HeantRanf® Plus 1 th be neta A SE Sa ere ar emememetree = one | Page 3 of 5 a ote oe eater 2 mre eeemunmne ne oe sem caret te pune eee eee Ne aes eaeanT 1a tome pe marine setel aaa Tt Teer seine mimedee soe 2 erro tent ees a eet oe ware es eto we ENR eee tet oe dae BRE OT ee OTM ge nee oe Unither Pharma - Doctor's Corner | Home | Shop HeartBar ' Unither Pharma Health for a New Generation HeartBar® Products @ About HeartBar® Company Information @ About Unither Pharma # Scientific Advisory Board # Contact Science Library # Definition of Terms @ Reviews -— # Journal Abstracts @ Clinical Studies @ Pre-Clinical Studies + About Heart Disease Doctor's Corner Doctor's Corner John P. Cooke Vascular Medicine Stanford University School of Medicine Stanford, CA.

A Nutritional Approach to a Healthy Endothelium: Case Histories I have been studying the endothelium for the better part of two decades, first at Mayo where I was trained, then as an Assistant Professor at Harvard, and now as Associate Professor and Director of the NIH-funded Vascular Medicine Program at Stanford. The endothelial lining of blood vessels is only one cell layer thick, but o tions ly As it exerts tremendous control over vessel tone, by producing Nitric @ Testimonials Oxide(NO), prostacyclin, and other vasodilators. An endothelial + MD Mentors Locator Customer's Corner enzyme known as NO synthase, produces NO and citrulline from the amino acid L-arginine. In patients with atherosclerosis, or with risk factors for atherosclerosis, the production of NO is Frequently Asked Questions reduced. Vasodilation is impaired in these individuals, and this @ Testimonials - impairment of endothelial function contributes to reduced A United Therapeutics coronary and peripheral blood flow. My group was the first to Corporation Company show that the impairment of NO synthesis could be reversed simply by administering exogenous L-arginine. Since then a number of groups including our own, have shown that high doses of arginine(6-9 grams daily) can improve coronary and peripheral blood flow, improve exercise tolerance and relieve symptoms of angina and intermittent claudication . However, it is difficult for patients to take 12-18 capsules of L-arginine daily, which is why I developed the arginine-enriched HeartBar® The HeartBar® has now been tested in rigorous, double-blind, placebo-controlled trials and has been shown to improve exercise tolerance and reduce pain in patients with coronary and peripheral arterial disease. Although these clinical trials are very gratifying, what I find even more satisfying are the positive results that I have observed in my own clinic. Here are a few representative anecdotes: :

Page | of 3 EF. Go. & vem ee ae arerereentiecete es To tec toto St eT ee gry weet ee ae Rteaneteene teeter ee cote states teint nee Ne eo semteian nee e Unither Pharma - Doctor's Comer . L, A 65 y/o male with chest pain 'M. M. is the chief executive officer of an educational company. His job is stressful, and his hypertension, hypercholesterolemia, and diabetes have, over the years, taken a toll on his heart. In 1975 he underwent coronary artery bypass grafting X3 (at that time he : stopped smoking). ‘Since then he has had two myocardial - : , infarctions and multiple angioplasties. He presented to my clinic in 1995, with an exacerbation of his angina. I increased his. medical therapy, getting his blood pressure, diabetes and high cholesterol under control. However, despite the best medical therapy he showed up in my clinic again in 1998 with more chest pain. Coronary angiography at that time shiowed that his bypass grafts were diffusedly diseased, and the severity of disease in his : native vessels would make revascularization difficult. He was oe already on maximal medical therapy, and he was taking. 3 nitroglycerin about 3-6 times daily for breakthrough chest pain. I told Mr. M. that he would need to make some lifestyle changes (exercise, stress reduction, diet) to enhance his heart (and. ; endothelial) health. I also asked him to try the HeartBar. At his next visit to me a couple of weeks later, Mr. M. was radiant. The angina had improved markedly. He rarely needed to use nitroglycerin. He was even able to get back to his old work schedule. At the time of this writing, Mr. M. is enjoying life with less pain. | , A 78 y/o male with intermittent claudication L. M. is a vigorous 78 year old man who looks younger than his stated age. As an alpine biologist, one of his classes each year involved a month of hiking over the heights of Yosemite and King's Canyon. Now, in retirement he is still an outdoorsman, and enjoys outdoor activities with his son. For the last few years though, he had noticed cramping in his legs after walking up a hill. The discomfort would subside if he stood still for a moment, and then he could go on. But about two years ago, the cramping became a real disability for him. He was tightening up after walking a half-mile, and he could only go that far if he walked slowly. The great outdoors was getting farther away for LM.

He came to my Vascular Medicine clinic at Stanford in the spring of 1999. I prescribed Trental 400 tid. He returned to me 6 weeks later with little improvement. At that point I stopped the Trental Page 2 of 3 w se ewewee ae een.

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rom Unither Pharma - Doctor's Comer and introduced him to the HeartBar. LM began taking two bars daily. It wasn't long before he noticed an improvement, and over time, he continued to improve. At the time of this writing, LM is able to walk faster, without pain, and-considers himself unlimited. He Is even able to jog a quarter of a mile before he needs to slow down. He's back to the hills, and enjoying the outdoors again with his son.

I hore that you found these anecdotes interesting. I welcome you to send in your own anecdotes regarding your experience with this autritional therapy.

With warmest regards, John P. Cooke, MD Ph.D.

Associate Professor and Director Section of Vascular Medicine Stanford University School of Medicine If you have any questions, please feel free to contact us. All Rights Reserved, Unither Pharma 2001, 2002 sete etwas oh meaveen ge eet Sorgeea rate at PADRES Rate Peer a or ee OL wternes:

ve Fete e eer ee ome romnnmes oon op Rat Aen ratnt + Unither Pharma - Doctor's Comer Home | Shop HeartBar Unither Pharma Health for a New Generation HeartBar® Products + About HeartBar® Doctor's Corner > Medical Food . . Alan S. Bailer @ Osder-HeastBar Products Cardiovascular Diseases ‘1330 Cottman Ave.

# About Unither Pharma Philadelphia, PA 19111 @ Contact Science Library # Definition of Terms Atenolol, and sublingual Nitroglycerin. Doctor's Corner #@ Frequently Asked Questions Understandably, he is not anxious to undergo repeat # Testimonials revascularization. Approximately 18 months ago, I read studies # MD Mentors Locator which confirmed that L-Arginine, in the form of the HeartBar, Customer's Corner + Frequently Asked substantially. I suggested that my father try on eee aials daily. After approximately 6 weeks of addin Tes\non=-—_— to his regimen, he is rarely experiencing an A United Therapeutics rest presently Corporation Company Lam convinced that, without the HeartBars, my father would have had to undergo another revascularization. Thank you, Cooke Pharma, for this wonderful product.

Patient Success Story bypass grafting imately 10 ienced progressive Reviews My 77 year old father had a triple coronary artery @ Journal Abstracts procedure in 1984. He was angina free for app @ Clinical Studies years. Gradually, since that time, he has exper ‘angina with exertion. His medications include Norvasc, Imdur, increased the blood flow through the coronary e HeartBar twice HeartBars daily gina and has.none at If you have any questions, please feel free to contact us. All Rights Reserved, Unither Pharma 2001, 2002 _ Page 1 of 1 tenet mee dee ee ee tee | enter nes ne Pate see PACED ee.

5 1 8 1 1 2 1961 348 83 194 66.350334 Unither5 1 8 1 1 3 1975 569 45 91 96.920486 Pha2 1 9 0 0 0 1924 359 34 401 -1 3 1 9 1 0 0 1924 359 34 401 -1 4 1 9 1 1 0 1924 359 34 401 -1 5 1 9 1 1 1 1924 359 30 90 79.869873 Heutth5 1 9 1 1 2 1924 452 34 44 92.938530 for5 1 9 1 1 3 1930 512 18 7 60.169025 a5 1 9 1 1 4 1931 526 25 64 88.945915 News 1 9 1 1 5 1933 597 24 150 53.480396 Generutiva5 1 9 1 1 6 1947 757 3 3 35.584930 -2 1 10 0 0 0 0 922 0 107 -1 3 1 10 1 0 0 0 922 0 107 -1 4 1 10 1 1 0 0 945 0 80 -1 5 1 10 1 1 1 0 945 0 80 95.000000 4 1 10 1 2 0 0 922 0 104 -1 5 1 10 1 2 1 0 922 0 104 95.000000 4 1 10 1 3 0 0 922 0 107 -1 5 1 10 1 3 1 0 922 0 107 95.000000 2 1 11 0 0 0 2183 333 42 648 -1 3 1 11 1 0 0 2183 333 42 648 -1 4 1 11 1 1 0 2183 333 42 648 -1 5 1 11 1 1 1 2183 333 38 145 92.020622 Unither5 1 11 1 1 2 2185 489 36 148 93.147514 Pharma5 1 11 1 1 3 2198 647 5 15 93.147514 -5 1 11 1 1 4 2188 675 35 160 95.597076 Doctor's5 1 11 1 1 5 2190 848 35 133 95.597076 Corner2 1 12 0 0 0 1957 349 17 415 -1 3 1 12 1 0 0 1957 349 17 415 -1 4 1 12 1 1 0 1957 349 17 415 -1 5 1 12 1 1 1 1957 349 17 415 95.000000 2 1 13 0 0 0 787 343 1114 406 -1 3 1 13 1 0 0 1826 346 75 340 -1 4 1 13 1 1 0 1866 347 35 339 -1 5 1 13 1 1 1 1866 347 34 175 90.846100 HeartBar®5 1 13 1 1 2 1873 533 28 153 95.886253 Products4 1 13 1 2 0 1826 346 32 280 -1 5 1 13 1 2 1 1830 346 28 27 91.931595 @5 1 13 1 2 2 1818 384 46 85 92.472694 About5 1 13 1 2 3 1818 483 46 147 80.429321 HeartBar®3 1 13 2 0 0 1751 346 70 348 -1 4 1 13 2 1 0 1788 347 33 347 -1 5 1 13 2 1 1 1794 347 27 24 79.176331 @5 1 13 2 1 2 1788 383 32 311 67.195618 ingredients/Nutritions4 1 13 2 2 0 1751 346 31 226 -1 5 1 13 2 2 1 1755 346 27 26 67.784088 @5 1 13 2 2 2 1742 384 45 108 95.719276 Medical5 1 13 2 2 3 1753 507 27 65 94.434746 Food3 1 13 3 0 0 1509 344 235 405 -1 4 1 13 3 1 0 1712 346 32 318 -1 5 1 13 3 1 1 1702 384 47 103 96.136383 Dietary5 1 13 3 1 2 1702 502 47 162 83.145721 Supplement4 1 13 3 2 0 1674 346 32 394 -1 5 1 13 3 2 1 1665 384 46 81 93.133698 Orders 1 13 3 2 2 1665 480 46 119 90.081802 HeartBar5 1 13 3 2 3 1665 614 46 131 96.497597 Products4 1 13 3 3 0 1622 346 38 366 -1 5 1 13 3 3 1 1622 346 33 159 96.018112 Company5 1 13 3 3 2 1630 516 30 196 90.018036 Information4 1 13 3 4 0 1584 344 32 357 -1 5 1 13 3 4 1 1589 344 27 29 74.844940 @5 1 13 3 4 2 1575 383 47 83 92.798210 About5 1 13 3 4 3 1575 481 47 102 91.949188 Unither5 1 13 3 4 4 1575 598 47 107 96.471588 Pharma4 1 13 3 5 0 1547 345 33 404 -1 5 1 13 3 5 1 1537 380 47 142 27.878738 Scientific5 1 13 3 5 2 1537 536 47 119 96.816307 Advisory5 1 13 3 5 3 1537 670 47 83 96.606750 Board4 1 13 3 6 0 1509 344 32 149 -1 5 1 13 3 6 1 1509 382 29 111 96.499840 Contact3 1 13 4 0 0 1455 346 37 264 -1 4 1 13 4 1 0 1455 346 37 264 -1 5 1 13 4 1 1 1455 346 35 131 96.219154 Sciences 1 13 4 1 2 1459 490 33 120 96.549904 Library3 1 13 5 0 0 1419 344 33 312 -1 4 1 13 5 1 0 1419 344 33 312 -1 5 1 13 5 1 1 1423 344 29 29 52.583916 @5 1 13 5 1 2 1419 382 31 274 96.552902 Definitions 1 13 5 1 3 1410 532 48 28 96.803757 of5 1 13 5 1 4 1419 572 31 84 93.208183 Terms3 1 13 6 0 0 1378 345 34 215 -1 4 1 13 6 1 0 1378 345 34 215 -1 5 1 13 6 1 1 1385 345 27 28 0.000000 @5 1 13 6 1 2 1381 383 29 117 0.000000 Reviews3 1 13 7 0 0 1343 345 31 292 -1 4 1 13 7 1 0 1343 345 31 292 -1 5 1 13 7 1 1 1347 345 27 28 84.528610 @5 1 13 7 1 2 1334 382 45 106 95.892052 Journals 1 13 7 1 3 1334 502 45 139 96.081833 Abstracts3 1 13 8 0 0 1269 345 67 320 -1 4 1 13 8 1 0 1307 345 29 260 -1 5 1 13 8 1 1 1310 345 26 27 61.241470 #5 1 13 8 1 2 1307 382 27 105 96.536133 Clinical5 1 13 8 1 3 1308 499 27 106 96.504288 Studies4 1 13 8 2 0 1269 345 30 320 -1 5 1 13 8 2 1 1273 345 25 204 12.341644 Pre-Clinical5 1 13 8 2 2 1260 563 43 105 33.599663 Studies3 1 13 9 0 0 1183 346 80 331 -1 4 1 13 9 1 0 1231 346 32 331 -1 5 1 13 9 1 1 1235 346 28 26 75.310318 @5 1 13 9 1 2 1231 382 26 85 95.873222 About5 1 13 9 1 3 1232 477 27 76 95.623695 Hearts 1 13 9 1 4 1233 563 28 114 96.331276 Disease4 1 13 9 2 0 1183 346 30 268 -1 5 1 13 9 2 1 1183 346 29 139 74.045357 Doctor's5 1 13 9 2 2 1186 499 27 115 96.114563 Corner3 1 13 10 0 0 1104 344 68 289 -1 4 1 13 10 1 0 1140 344 32 289 -1 5 1 13 10 1 1 1143 344 29 27 46.832687 ~@5 1 13 10 1 2 1132 386 46 147 76.205269 Frequently5 1 13 10 1 3 1132 550 46 86 97.002052 Asked4 1 13 10 2 0 1104 345 29 144 -1 5 1 13 10 2 1 1104 345 29 144 96.652260 Questions3 1 13 11 0 0 1068 344 31 220 -1 4 1 13 11 1 0 1068 344 31 220 -1 5 1 13 11 1 1 1072 344 27 27 63.923233 @5 1 13 11 1 2 1068 382 29 182 96.459427 Testimonials3 1 13 12 0 0 983 343 79 329 -1 4 1 13 12 1 0 1031 343 31 329 -1 5 1 13 12 1 1 1035 343 27 28 20.219788 -@5 1 13 12 1 2 1031 387 26 35 92.804710 MD5 1 13 12 1 3 1022 440 45 113 92.804710 Mentors5 1 13 12 1 4 1022 567 45 110 65.048859 Locator4 1 13 12 2 0 983 344 30 323 -1 5 1 13 12 2 1 983 344 30 192 66.731186 Customer's5 1 13 12 2 2 987 550 26 117 96.301300 Corner3 1 13 13 0 0 900 344 73 289 -1 4 1 13 13 1 0 938 344 35 289 -1 5 1 13 13 1 1 938 344 35 27 61.607491 #5 1 13 13 1 2 929 382 51 154 96.926788 Frequently5 1 13 13 1 3 929 552 51 81 96.919052 Asked4 1 13 13 2 0 900 344 33 143 -1 5 1 13 13 2 1 900 344 33 143 95.916862 Questions3 1 13 14 0 0 866 344 33 219 -1 4 1 13 14 1 0 866 344 33 219 -1 5 1 13 14 1 1 871 344 28 27 15.096481 @5 1 13 14 1 2 866 382 31 181 94.444519 Testimonials3 1 13 15 0 0 787 343 67 319 -1 4 1 13 15 1 0 821 343 33 319 -1 5 1 13 15 1 1 826 343 22 22 96.906326 A5 1 13 15 1 2 814 372 44 92 96.140076 United5 1 13 15 1 3 814 478 44 184 96.498100 Therapeutics4 1 13 15 2 0 787 343 30 315 -1 5 1 13 15 2 1 783 339 38 181 95.768806 Corporations 1 13 15 2 2 790 532 27 126 95.092957 Company2 1 14 0 0 0 1666 439 9 226 -1 3 1 14 1 0 0 1666 439 9 226 -1 4 1 14 1 1 0 1666 439 9 226 -1 5 1 14 1 1 1 1666 439 9 226 95.000000 2 1 15 0 0 0 1501 439 9 226 -1 3 1 15 1 0 0 1501 439 9 226 -1 4 1 15 1 1 0 1501 439 9 226 -1 5 1 15 1 1 1 1501 439 9 226 95.000000 2 1 16 0 0 0 1222 438 8 227 -1 3 1 16 1 0 0 1222 438 8 227 -1 4 1 16 1 1 0 1222 438 8 227 -1 5 1 16 1 1 1 1222 438 8 227 95.000000 2 1 17 0 0 0 1020 439 10 226 -1 3 1 17 1 0 0 1020 439 10 226 -1 4 1 17 1 1 0 1020 439 10 226 -1 5 1 17 1 1 1 1020 439 10 226 95.000000 2 1 18 0 0 0 859 438 8 227 -1 3 1 18 1 0 0 859 438 8 227 -1 4 1 18 1 1 0 859 438 8 227 -1 5 1 18 1 1 1 859 438 8 227 95.000000 2 1 19 0 0 0 0 1275 0 50 -1 3 1 19 1 0 0 0 1275 0 50 -1 4 1 19 1 1 0 0 1275 0 50 -1 5 1 19 1 1 1 0 1275 0 50 95.000000 2 1 20 0 0 0 2026 810 33 326 -1 3 1 20 1 0 0 2026 810 33 326 -1 4 1 20 1 1 0 2026 810 33 326 -1 5 1 20 1 1 1 2027 810 29 83 96.866058 Homes 1 20 1 1 2 2026 903 30 6 96.345123 |5 1 20 1 1 3 2018 929 45 61 93.267792 Shops 1 20 1 1 4 2018 1004 45 132 0.000000 HeartBar Doctor's Corner Marcus S. Kryger Box 280 Forsyth, MO 65653 PVD Patient Success Stories 82 Year old white female with ischemic cardiomyopathy and severe peripheral vascular disease by IMEX scan. ‘Unable to walk 1 block due to leg pain and dyspnea. She was scheduled for femoral artery bypass, but started on HeartBar. Three months later, without surgery or other medical changes, she was walking 2 miles daily and continues to do so, without symptoms, 15 months later. 50 Year old male with persistent polymorphic ventricular ectopy and. paroxysmal dyspnea, 4 months after PTCA/stent placement (with good angiographic results). Two weeks after starting HeartBar, all symptoms resolved, and remains asymptomatic and fully functional 18 months later on’ 1 HeartBar daily. .

86 Year old white male with CHF due to ischemic cardiomyopathy and severe leg pain on walking over 50 feet. Started on HeartBar BID, no other changes in medical regime. A month later he repaired his roof by himself without any symptoms. He felt well for 4 months then stopped HeartBar. He rapidly became more dyspneic; restarted HeartBar BID with prompt improvement and went deer hunting this past fall.

If you have any questions, please feel free to contact us. All Rights Reserved, Unither Pharma 2001, 2002 t 34 1 35 1 2 0 570 3228 17 7 -1 5 1 35 1 2 1 570 3228 17 7 87.154778 i4 1 35 1 3 0 557 3229 10 6 -1 5 1 35 1 3 1 557 3229 10 6 66.592735 44 1 35 1 4 0 533 3227 18 7 -1 5 1 35 1 4 1 533 3227 18 7 47.723217 }2 1 36 0 0 0 115 3228 103 11 -1 3 1 36 1 0 0 115 3228 103 11 -1 4 1 36 1 1 0 115 3228 103 11 -1 5 1 36 1 1 1 115 3228 67 11 11.342392 serene5 1 36 1 1 2 192 3229 26 6 30.924866 net2 1 37 0 0 0 2 3296 2546 4 -1 3 1 37 1 0 0 2 3296 2546 4 -1 4 1 37 1 1 0 2 3296 2546 4 -1 5 1 37 1 1 1 2 3296 2546 4 95.000000 Unither Pharma - Doctor's Commer Page 1 of 1 Home | Shop HeartBar Health for a New Generatipa HeartBar® Products 7 ® About HeartBar® Doctor's Corner : Dietary Supplement Peter Gray i @ Order HeartBar Products 90 South St. Company Information Glens Falls, NY 12801 @ About Unither Pharma o Scientific Advisory Board - Great Results--Reducing Angina Episodes, Claudication, Contact Improving Exercise Capacity Science Library Great results regarding: ‘, e Improving exercise capacity in patients with stable angina, e Reducing anginal episodes, and ;

e Reducing claudication. : ‘ Doctor's Corner @ Frequently Asked .

Questions . I'm now using it with my father for claudication with excellent =n oolals results.

Customer's Corner @ Frequently Asked - #@ Testimonials If you have any questions, please feel free to contact us. A United Therapeutics Corporation Company All Rights Reserved, Unither Pharma 2001, 2002 a ate + 2 ene a nr no Stee meee, co emt eetne HAASE OIR Eom attoe oe oe a Unither Pharma - Frequently Asked Questions for Patients ; ; ‘Home | Shop HeartBar Unither Pharm Health for a New Gensrativa HeartBar® Products; . a .

¢ About HeartBars Frequently Asked Questions for Patients Ingredients/Nutritions; :

@ Medical Food @ Dietary Supplement; ; .

-@ Order HeartBar Products Don't see an answer to your question, please contact us. Company Information _# About Unither Pharma + Contact Table of Contents Science Library @ Reviews ° What is HeartBar®@? 2 Jowoal Abswatis e Who are HeartBar® products for? Clinical Sluc’es e What's in HeartBar®? pee eine iene What is L-arginine? Doctor's Corner e How does HeartBar® Work? . ; @ Frequently Asked e Is HeartBar® Plus a replacement for existing medical ‘ Questions approaches to treating coronary artery and vascular ne Con — « What are the contraindications for HeartBar®? @ Fre « What foods do you have to eat to get a lot of L-arginine? Frequently Asked ° coe gtge tt Questions e What is the scientific justification for the product? Testimonials + Are there any adverse effects from eating HeanBar®? A United Therapeutics e Who regulates medical foods? Corporation Company » What are other examples of medical foods? What is HeartBar®? See What is HeartBar®? [back to top] Who are HeartBar® products for? HeartBar® products are designed for different individuals:

Page 1 of 6 a.

Ce lf yu nun InAnn eee ee seme e ed Sra in ave ate ee Unither Pharma - Frequently Asked Questions for Patients HeartBar® Plus, the medical food, is intended for cardiovascular patients who are under the active care of a physician. It is a safe, effective and convenient way that may significantly increase nitric oxide production for an estimated 16 million people who have been diagnosed with coronary and peripheral artery disease. Extensive scientific research shows that nitric oxide is deficient in people with these diseases as well as those with risk factors for heart disease such as high cholesterol,*high blood pressure, diabetes, estrogen deficiency and tobacco use.

HeartBar® Sport, the dietary supplement, is intended for older adults or at-risk individuals who wish to maintain good cardiovascular health, as well as benefit from increased energy and endurance. ;

[back to top] What's in HeartBar®? See Nutritional Content.

[back to top] What is L-arginine? See L-arginine.

[back to top] How does HeartBar® Work? ' The active ingredient of all HeartBar® products is Larginine, an amino acid used by the human body to Page 2 of 6 TS oe eet oe tree nee mete * emer ren once meee TURES TAH RS ETRE Aw ee Unither Pharma - Customer's Testimonials Mary R. Gompf from OH © HeartBar, 1 noticed a dramatic reducti energy to do. Thank you."

to their cardiologist."

It5 1 12 1 1 2 1959 878 33 68 96.246857 was5 1 12 1 1 3 1955 957 37 70 96.409416 just5 1 12 1 1 4 1966 1041 30 59 96.224228 likes 1 12 1 1 5 1963 1115 30 52 96.956841 my5 1 12 1 1 6 1972 1183 29 116 96.929527 Doctors 1 12 1 1 7 1976 1311 32 79 96.488785 said.5 1 12 1 1 8 1980 1405 36 85 96.997421 After5 1 12 1 1 9 1978 1502 36 71 96.895760 only5 1 12 1 1 10 1987 1588 29 19 96.988586 22 1 13 0 0 0 1815 823 104 836 -1 3 1 13 1 0 0 1815 823 104 836 -1 4 1 13 1 1 0 1860 823 59 685 -1 5 1 13 1 1 1 1860 823 36 50 85.137863 legs 1 13 1 1 2 1861 889 39 85 96.161179 pain.5 1 13 1 1 3 1867 991 36 48 96.504211 My5 1 13 1 1 4 1866 1054 37 120 96.510735 energy5 1 13 1 1 5 1882 1189 33 79 96.490913 levels 1 13 1 1 6 1885 1283 32 69 96.420120 also5 1 13 1 1 7 1889 1366 30 142 96.475143 increase4 1 13 1 2 0 1815 823 65 836 -1 5 1 13 1 2 1 1815 823 36 109 96.677711 things5 1 13 1 2 2 1826 946 32 74 96.677711 with5 1 13 1 2 3 1824 1035 29 53 96.379654 my5 1 13 1 2 4 1826 1102 44 208 90.858795 great-grand5 1 13 1 2 5 1842 1325 33 136 96.679482 children5 1 13 1 2 6 1847 1476 31 68 96.961067 that5 1 13 1 2 7 1851 1558 29 12 94.565010 I5 1 13 1 2 8 1844 1585 32 74 96.854012 prev2 1 14 0 0 0 1851 1510 176 457 -1 3 1 14 1 0 0 1851 1510 176 457 -1 4 1 14 1 1 0 1987 1622 40 339 -1 5 1 14 1 1 1 1989 1622 36 105 96.936386 weeks5 1 14 1 1 2 1993 1741 30 34 96.992058 of5 1 14 1 1 3 1987 1786 38 106 96.868965 taking5 1 14 1 1 4 1999 1906 28 55 97.016663 thea 1 14 1 2 0 1936 1629 48 308 -1 5 1 14 1 2 1 1936 1629 30 17 93.249168 y5 1 14 1 2 2 1940 1661 37 113 97.010864 angina5 1 14 1 2 3 1942 1789 39 72 96.996735 pains 1 14 1 2 4 1954 1875 30 62 95.978081 anda 1 14 1 3 0 1888 1510 49 457 -1 5 1 14 1 3 1 1888 1510 37 29 91.566795 d,5 1 14 1 3 2 1894 1555 36 140 96.927689 allowing5 1 14 1 3 3 1902 1711 25 52 95.436043 me5 1 14 1 3 4 1905 1776 28 33 96.528816 to5 1 14 1 3 5 1906 1824 31 41 95.395615 do5 1 14 1 3 6 1909 1879 24 88 96.458199 more4 1 14 1 4 0 1851 1662 44 290 -1 5 1 14 1 4 1 1851 1662 37 97 15.664139 iously5 1 14 1 4 2 1859 1774 34 109 96.247688 lacked5 1 14 1 4 3 1864 1897 31 55 96.743057 the2 1 15 0 0 0 1704 828 108 1161 -1 3 1 15 1 0 0 1704 828 108 1161 -1 4 1 15 1 1 0 1782 1319 30 670 -1 5 1 15 1 1 1 1782 1319 30 670 0.000000 _—4 1 15 1 2 0 1704 828 69 875 -1 5 1 15 1 2 1 1704 828 29 63 96.630836 Ms.5 1 15 1 2 2 1708 906 29 90 93.135277 Jeans 1 15 1 2 3 1711 1013 35 138 92.967003 Lariscy5 1 15 1 2 4 1720 1165 30 79 96.264107 from5 1 15 1 2 5 1724 1260 30 50 96.166901 GA5 1 15 1 2 6 1770 1701 3 2 10.953209 ,2 1 16 0 0 0 1301 829 375 1108 -1 3 1 16 1 0 0 1557 829 119 1108 -1 4 1 16 1 1 0 1606 829 70 1108 -1 5 1 16 1 1 1 1606 829 28 28 68.468628 I have had so many tests done by the hospital for the burning and pain in my feet and legs. I have taken so many different kinds of medication and nothing has he found I had mild atherosclerosis and believed the He help. Within 2 weeks I noticed an improve has improved, my energy has increased, an legs and feet and hip is so much better. have told my friends about the HeartBar and suggested the Iped. My Cardiologist artBar would ment. My circulation d the burning in my Thanks to HeartBars. | y talk | Ms. Jeree Perry from KY be a ‘Life Change’. Thanks."

N ) T5 1 25 1 1 4 1092 889 28 84 96.720604 have5 1 25 1 1 5 1097 988 27 62 96.716484 lots5 1 25 1 1 6 1100 1065 29 35 96.853317 of5 1 25 1 1 7 1098 1111 36 136 89.958717 ‘Natural5 1 25 1 1 8 1104 1263 36 139 87.828163 Energy’.5 1 25 1 1 9 1113 1418 32 128 96.281509 Instead5 1 25 1 1 10 1118 1561 31 33 96.431450 of5 1 25 1 1 11 1119 1607 29 41 93.109100 525 1 25 1 1 12 1114 1662 29 17 92.816833 y4 1 25 1 2 0 1044 848 61 834 -1 5 1 25 1 2 1 1044 848 31 53 96.806061 32.5 1 25 1 2 2 1047 919 30 10 91.239601 I5 1 25 1 2 3 1048 945 33 80 96.301094 walks 1 25 1 2 4 1053 1040 30 18 96.262177 35 1 25 1 2 5 1054 1075 28 34 89.579697 to5 1 25 1 2 6 1056 1124 30 18 89.579697 55 1 25 1 2 7 1057 1158 32 91 94.217415 miles5 1 25 1 2 8 1062 1263 23 18 94.217415 a5 1 25 1 2 9 1057 1297 37 59 97.007919 days 1 25 1 2 10 1066 1372 32 81 96.891502 after5 1 25 1 2 11 1068 1465 35 135 96.397293 workings 1 25 1 2 12 1076 1615 29 20 96.128113 85 1 25 1 2 13 1077 1648 27 34 96.128113 to2 1 26 0 0 0 1219 1936 62 72 -1 3 1 26 1 0 0 1219 1936 62 72 -1 4 1 26 1 1 0 1219 1936 62 72 -1 5 1 26 1 1 1 1219 1936 62 72 94.645813 =2 1 27 0 0 0 1079 1682 83 306 -1 3 1 27 1 0 0 1079 1682 83 306 -1 4 1 27 1 1 0 1122 1682 40 306 -1 5 1 27 1 1 1 1122 1682 24 72 96.881081 ears5 1 27 1 1 2 1126 1768 29 34 96.898659 of5 1 27 1 1 3 1122 1814 27 72 96.914444 age.5 1 27 1 1 4 1131 1902 27 12 93.406097 I5 1 27 1 1 5 1131 1927 31 61 96.638443 feel4 1 27 1 2 0 1079 1699 35 274 -1 5 1 27 1 2 1 1079 1699 29 38 95.233978 105 1 27 1 2 2 1081 1753 29 105 95.233978 hours.5 1 27 1 2 3 1086 1875 28 26 88.384583 It5 1 27 1 2 4 1088 1914 23 59 96.585709 can2 1 28 0 0 0 1014 1558 6 127 -1 3 1 28 1 0 0 1014 1558 6 127 -1 4 1 28 1 1 0 1014 1558 6 127 -1 5 1 28 1 1 1 1014 1558 6 127 95.000000 2 1 29 0 0 0 982 839 60 1179 -1 3 1 29 1 0 0 982 839 60 1179 -1 4 1 29 1 1 0 982 839 60 1179 -1 5 1 29 1 1 1 982 839 60 1179 95.000000 2 1 30 0 0 0 985 839 50 1179 -1 3 1 30 1 0 0 985 839 50 1179 -1 4 1 30 1 1 0 985 839 50 1179 -1 5 1 30 1 1 1 985 839 50 1179 95.000000 2 1 31 0 0 0 985 837 43 1181 -1 3 1 31 1 0 0 985 837 43 1181 -1 4 1 31 1 1 0 985 837 43 1181 -1 5 1 31 1 1 1 985 837 43 1181 95.000000 2 1 32 0 0 0 978 839 51 1179 -1 3 1 32 1 0 0 978 839 51 1179 -1 4 1 32 1 1 0 978 839 51 1179 -1 5 1 32 1 1 1 978 839 51 1179 95.000000 2 1 33 0 0 0 929 852 49 473 -1 3 1 33 1 0 0 929 852 49 473 -1 4 1 33 1 1 0 929 852 49 473 -1 5 1 33 1 1 1 929 852 35 220 96.411926 Bernadette5 1 33 1 1 2 941 1087 31 85 96.071693 Reid5 1 33 1 1 3 944 1186 30 80 96.071693 from5 1 33 1 1 4 948 1282 30 43 96.703949 NY2 1 34 0 0 0 777 854 125 1127 -1 3 1 34 1 0 0 777 854 125 1127 -1 4 1 34 1 1 0 830 854 72 1127 -1 5 1 34 1 1 1 830 854 28 28 73.435226 I don't expect a cure, but it is just so good not to have that leg pain any more. I can walk so much further." Mr. Barry Dangler from FL My5 1 39 1 1 2 618 940 36 211 96.722351 Cardiologists 1 39 1 1 3 628 1165 39 248 96.469994 recommended5 1 39 1 1 4 638 1428 31 55 93.298859 thes 1 39 1 1 5 636 1497 38 154 92.668617 HeartBar5 1 39 1 1 6 647 1663 28 34 96.706207 to5 1 39 1 1 7 649 1711 24 62 96.425430 me.5 1 39 1 1 8 652 1788 31 86 96.638138 After5 1 39 1 1 9 657 1885 31 101 96.656715 about5 1 39 1 1 10 662 1999 27 20 96.972137 24 1 39 1 2 0 569 862 77 1143 -1 5 1 39 1 2 1 569 862 33 120 96.756500 weeks,5 1 39 1 2 2 569 1000 41 116 95.949928 peoples 1 39 1 2 3 584 1131 26 34 96.725555 at5 1 39 1 2 4 586 1178 31 85 96.110229 works 1 39 1 2 5 590 1276 23 83 96.304909 were5 1 39 1 2 6 590 1373 34 109 96.580322 asking5 1 39 1 2 7 594 1498 26 62 96.897469 me,5 1 39 1 2 8 596 1576 34 112 94.745125 ‘Barry,5 1 39 1 2 9 606 1705 32 109 87.332207 what's5 1 39 1 2 10 604 1828 37 93 96.556885 going5 1 39 1 2 11 615 1936 31 69 50.538841 on? I told them about the HeartBar and how muc now have. I was very tired and sleeping a doing things, like yard work, that I haven't done in 2 years. Cardiologist has taken me. off of imdur for my angina pain now that I'm taking the HeartBar. I feel great." h more energy | lot. Now I'm back My Ms. Betty Burke from CA “I had severe burning pain in my left leg when Iran up hills. My AB Index, done by Stanford Research, in my left leg was only .5. I read on the Internet that a .4 Index might require amputation. Page 3 of 8 3/26/2002 Fn deer ene tt Unither Pharma - Customer's Testimonials | Page 4 of 8 a) . After 2 weeks taking the HeartBar, the burning pain is gone! I wi ; can run with no pain: I also don't have any leg pain when playing , tennis. I was seen by a vascular surgeon who proclaimed that I . : had excellent circulation in both legs. HeartBar has really changed my life!" ; i ed bedi i sn William E. Doxon from KS F “My name is William E. Doxon. I would like to give you a short overview of my heart and subsequent diabetes history and my experience with HeartBar. I had open-heart surgery in November of 1976. Since then I have had 3 balloonings; I had a light heart attack during fhe last ballooning. The doctors told me I probably would havea major attack at some point. One month later I did. After taking various heart medications for years, I developed : diabezes. My legs and feet have been icy cold for some time. My . hips «znd legs hurt whether working or at rest. In my work, | unload freight loads of chemicals used in commercial } dishwashers. I also service the machines. In July of 1999 my doctor couldn't find a pulse in either foot. I went to a vascular specialist who put in 2 stents, one in each grain area. Still no pulsel! In December of 1999 I went back to the same specialist who then put three more stents in the same area. Still no pulse in miy feet!! About two weeks after the last stents, my doctor called and asked me to try a new product called HeartBar. I was to eat two : a day. I used them as my midmoring and midafternoon snacks. ; Within two weeks, I had a weak pulse in both feet. Since then, the pulse has gotten stronger. In fact, I've had to take my shoes off sometimes because my feet were so warm. I can now work or walk without pain. I firmly believe that anyone with vascular problems will benefit from eating two HeartBars a day. I get tired of having to remember to eat anything twice a day. But this is, after all, a medication and should be treated as such. Thanks Cooke Pharma!i!."

sccanttemeente ee eee eh ete Ms. Dorothy Johnston from CA “Before taking the HeartBar, I had to stop half way up the 15 ‘ stairs to my house. I also had to stop part way up an incline to : the building where I did my pool therapy because of my angina pain. Now I can walk the stairs and to the pool without stopping and with no pain. I'm also walking 20 minutes to half an hour . with a friend at least once a week with no problem. HeartBar has Letee meepe rege bg spe ge eateatne a Be tetatngts cenenee ere b ggaee barman: See cee tenements Unither Pharma - Custom er's Testimonials g difference In my daily life."

|really made a bi ska from CA poth legs. After 2 angloplasties on my ctor put me on HeartBar. Further angioplasty 20% risk of amputation. I had been to about 3 minu g pain forced me tes before debilitating le After about @ month on th 1 was able to walk ith no pain! 1 now have much less pain than i s recommendation, L started on the HeartBar My. energy level has really increased. [I've more ‘ he number of taps } swim to 20 now, and can swim these ev m done, ! feel ure has dropped an ed. I've also started lifting weig el like 4 kid again.

energy.

rtBar has given m in6 months). My angina pains Lam5 1 38 1 1 2 377 1075 36 118 96.317566 almost5 1 38 1 1 3 391 1207 22 40 96.317566 an5 1 38 1 1 4 397 1261 46 232 92.324768 Octogenarian5 1 38 1 1 5 416 1507 35 13 93.077858 (4 1 38 1 2 0 322 966 136 1108 -1 5 1 38 1 2 1 322 966 28 83 96.748177 have5 1 38 1 2 2 332 1064 32 58 96.738640 left5 1 38 1 2 3 340 1135 25 53 96.418549 me5 1 38 1 2 4 347 1203 34 61 96.660431 ands 1 38 1 2 5 352 1280 29 51 96.171783 my5 1 38 1 2 6 362 1347 40 163 89.400055 breathing5 1 38 1 2 7 380 1525 29 58 96.636391 has5 1 38 1 2 8 389 1597 32 135 96.168060 becomes 1 38 1 2 9 404 1746 21 18 95.245399 a5 1 38 1 2 10 407 1777 29 45 95.245399 lots 1 38 1 2 11 413 1835 34 114 94.899773 easier.5 1 38 1 2 12 426 1963 29 13 46.359711 J5 1 38 1 2 13 429 1991 29 83 94.489258 have4 1 38 1 3 0 279 970 122 956 -1 5 1 38 1 3 1 279 970 31 57 96.858032 not5 1 38 1 3 2 286 1041 35 63 96.034241 had5 1 38 1 3 3 296 1118 25 34 95.980751 to5 1 38 1 3 4 300 1167 26 59 96.421234 uses 1 38 1 3 5 305 1242 28 50 94.156204 my5 1 38 1 3 6 315 1309 41 172 90.647064 Nitro-Stat5 1 38 1 3 7 327 1494 39 66 95.075790 pills5 1 38 1 3 8 342 1573 30 88 96.945305 since5 1 38 1 3 9 352 1674 28 13 86.525566 15 1 38 1 3 10 354 1700 41 121 95.714836 started5 1 38 1 3 11 369 1836 32 90 95.697998 using3 1 38 2 0 0 296 1561 84 567 -1 4 1 38 2 1 0 296 1561 84 567 -1 5 1 38 2 1 1 297 1561 28 14 87.680275 t5 1 38 2 1 2 296 1588 30 51 95.657410 my5 1 38 2 1 3 308 1654 39 140 19.182220 Doctor's5 1 38 2 1 4 325 1807 29 52 96.999855 OK5 1 38 2 1 5 330 1871 30 69 96.375557 firsts 1 38 2 1 6 338 1951 25 34 92.731735 to5 1 38 2 1 7 344 1999 24 60 43.793369 uses 1 38 2 1 8 351 2072 29 56 96.622963 the2 1 39 0 0 0 0 3007 0 22 -1 3 1 39 1 0 0 0 3007 0 22 -1 4 1 39 1 1 0 0 3007 0 22 -1 5 1 39 1 1 1 0 3007 0 22 95.000000 2 1 40 0 0 0 257 1188 63 371 -1 3 1 40 1 0 0 257 1188 63 371 -1 4 1 40 1 1 0 257 1188 63 371 -1 5 1 40 1 1 1 257 1188 32 56 96.981506 not5 1 40 1 1 2 265 1257 40 133 85.351997 a.singles 1 40 1 1 3 281 1404 27 74 56.015984 one.5 1 40 1 1 4 287 1492 33 67 12.538002 1go02 1 41 0 0 0 272 1558 26 4 -1 3 1 41 1 0 0 272 1558 26 4 -1 4 1 41 1 1 0 272 1558 26 4 -1 5 1 41 1 1 1 272 1558 26 4 95.000000 2 1 42 0 0 0 187 973 87 210 -1 3 1 42 1 0 0 191 973 83 210 -1 4 1 42 1 1 0 235 973 39 210 -1 5 1 42 1 1 1 235 973 39 210 90.057632 HeartBars—4 1 42 1 2 0 187 977 59 203 -1 5 1 42 1 2 1 187 977 59 203 30.110092 HeartBars. ol antale agnTFAQTypelD=? ragevv~ 3/26/2002 Cookernarma - About HeartBars HeartBar’ Product Information @ About HeartBar® @ Product Line @ Patients FAQs @ Doctors FAQs @ Common Terms Company Information @ Contact Information @ News @ Background Science Library @ Reviews ® Medical Abstracts @ Clinical Studies @ Pre-Clinical Studies @ About Heart Disease Scientific Advisory Patients’ Testimonials Doctor's Corner COOKE PRARASA A Unither Pharmaceuticals Company http://www.co kepharma.com/aboutHeartBars.asp -Page 1 of 1 Home | Peer Counselor Login | Peer-to-Peer Marketing | Peer Counselor Application Request HeartBar® Samples | Order HeartBar® Products | Find a Peer Counselor About HeartBars If you have heart disease, take two HeartBars a aay to feel a difference within two weeks! Recommended by doctors for dailv use Based on Nobel! Prize medical science and clinical research Eating two HeartBars a day helps open blood vessels and improves circulation with the following results: e Reduces painful symptoms of heart disease such as angina and leg pain e Helps increase mobility e Helps improve ability to exercise without pain, discomfort, or fatigue e Increases energy levels to help you live.a more active and enjoyable life Results are usually experienced within the. first two weeks. After t two weeks, one HeartBar® a day may be sufficient to maintain results. HeartBar® was developed. following ten years of extensive research at Stanford University and other leading medical centers. Based on the science that won the 1998 Nobel Prize in medicine, HeartBars feature a patented formula containing L-argenine, which helps improve circulation and create smoother, more efficient blood flow.

Ask you doctor or medical. professional about HeartBars, and learn how it helps people with heart disease to live 4 more active and ' enjoyable life.

If you have any quéstions; pledée feel freé'to contact us: All Rights Reserved, Cooke Pharma 200: 8/20/2001 1 mm seman eae getats BP Im oF tee, Bx. 8 5.4- * Cookepharma - Frequently Asked Questions for Doctors aenrr~e~ The price for 32 servings any combination of HeartBar® products is as follows:

. $59.99 for a single 32-serving order, plus shipping & handling » $49.99 for a 32-serving subscription order, plus shipping & handling [back to top] en How many HeartBars should a consumer eat a day to receive all of the heart and vascular benefits? Clinical research shows that, for best results, significant improvement in blood circulation, significant improvement (66%) in pain free walking distance and reduction in total and LDL cholesterol by 10%-15%, are achieved by eating two bars a day. Check out the HeartBar® ) product line for the new and exciting flavors! [back to. top] oo Who regulates medical foods? The U.S. Food and Drug Administration regulates medical foods. By law, medical foods are products specially formulated to supplement oral intake as part of the diet in the overall medical management ofa | condition or disease for which distinct nutritional requirements. are established by medical evaluation. Medical foods are only for use under the supervision of a physician. HeartBar® meets the , requirements of a medical food.

[back to top] What are other examples. of medical foods? HeartBar® meets the requirements of 2 medical food product. According to the FDA, other examples of medical foods include products for kidney and liver disease,compromised immune functions, diabetes, burns, Crohn's Disease and short bowel © syndrome. They are not intended for use like conventional food. [back to top] When was Cooke Pharma established? nrtp:/www cookepharma.com/tags.asp?F AQTYPeID=2 / or 8/20/2001 wee eet at trate mer cea sancamertantegnrmes Tcemeenye m Only Medical Food for the Uietary Management of Vascula; Lisease Use under the Supervision of a physician. Ask your pharmacist.

Recommended by Doctors for Daily Use ° Improves Circulation e Helps Reduce Angina & Leg Pain ° Provides Increased Energy | 16 50g (1.76 02) HeartBars NET WT. 800g (28.2 OZ [1 LB 12.2 O2Z)} rf - E.f.,.\ -If you have heart disease, take two HeartBars a day to feel a difference within two weeks. | . Eating two HeartBars a day helps open blood vessels and improves circulation with the following results: , e Reduces painful symptoms of heart disease such as angina and leg pain ° Helps increase mobility ¢ Helps improve ability to exercise without pain, « discomfort, or fatigue e Increases energy levels to help you live a more active and enjoyable life Results are usually experienced within the first two weeks. After two weeks, one HeartBar® a day may be sufficient to maintain results. Use under the supervision of a physician. Ask your pharmacist. Distributed by Cooke Pharma Inc., Belmont CA 94002 For tnore information about HeartBar”, : Call us toll free at (888) 808-6838 COOKE PHARMA .. — orvisit ourweb site at www.cookepharma.com _ Seun/wioseueydexoos mam//:diy ZOOZ/IT/S - Bdfwoy/Auaquery Sah/Soqe Tors c= Wr « c od a <= A nt iJ Hea' Fx.G o.h Is HeartBar® Right For You? Anyone concerned about the health of their heart will appreciate the benefits of adding HeartBar to his or her diet.. Because HeartBar is high in protein, vitamins, and minerals, and also low in fat and calories, it is an ideal snack food or meal ‘replacement for those who are on the go or are watching their weight.

If you are elderly, you might want to consider that as we age, our need for arginine in the diet increases. Eaten in the right amount, arginine can help prevent a variety of age-related vascular problems, including “hardening of the arteries” and plaque formation, and prevent or reverse the symptoms associated with them. If you have any of the following risk factors or symptoms of heart disease, HeartBar may be an important part of your daily health program:

Risk Factors Symptoms ¥ High Cholesterol! _ Chest pains _ © High Blood Pressure w Leg Pains ¥ Obesity @ Winded When Climbing Stairs ¥ Diabetes wv Low Energy w Low Estrogen 5 w Smoker: . HéstBar v Family History is the smart choice Call HeartBart Toll Free | 888 808 6838 Ex. G.e-a HeartBar® Improves Your Blood Flow.

Because the key ingredient in HeartBar’ improves the elasticity of your blood vessels and helps to keep vessels open, eating HeartBar’ products can contribute to better blood flow throughout your body-and can improve . your aerobic‘ performance.:For these reasons, even those who are not experiencing heart disease or age-related symptoms choose to make HeartBar’ a part of their daily regimen. Clinical Research Confirms that HeartBar®... w Improves circulation and blood flow for , better heart health. ; If you are...

w Increases exercise ability and improves © Athletic energy levels. Under Stress ~ Relieves painful symptoms such as angina ¥ Dieting and leg pain. Elderly ” Has been proven safe and effective.

YOU WOULD NEED TO TAKE UP TO 12 LARGE, ARGININE PILLS PER DAY TO EQUAL THE HesitBar . AMOUNT OF ARGININE IN JUST 2 HEARTBARS®. is the smart choice Call HeartBare Toll Free 3 88s 808 6838 See Results in Two Weeks! See Oetance In clinical studies, after only two weeks of eating two HeartBars: daily, patients showed significant.improvement in angina scores and quality of life.’ In patients suffering from PAD (peripheral artery disease), HeartBar' was shown to significantly improve the ability to walk pain free.” After the initial two weeks, 3 1 4 2 0 0 1130 743 1174 66 -1 4 1 4 2 1 0 1130 743 1160 44 -1 5 1 4 2 1 1 1130 766 53 21 93.285812 ones 1 4 2 1 2 1197 756 146 28 80.058708 HeartBar’5 1 4 2 1 3 1356 761 16 20 96.947670 a5 1 4 2 1 4 1384 754 53 32 96.947670 days 1 4 2 1 5 1449 757 60 27 96.997231 may5 1 4 2 1 6 1521 751 34 26 96.671455 be5 1 4 2 1 7 1568 748 130 28 96.747574 sufficient5 1 4 2 1 8 1858 750 12 16 71.467361 |.5 1 4 2 1 9 1878 748 74 18 94.370705 Maxwell5 1 4 2 1 10 1962 733 26 42 64.105942 AJ.5 1 4 2 1 11 1997 733 56 42 64.105942 Zapein5 1 4 2 1 12 2067 745 29 18 91.966644 MP.5 1 4 2 1 13 2109 733 46 42 88.264053 Cooke5 1 4 2 1 14 2163 744 23 18 91.812881 JP.5 1 4 2 1 15 2193 743 97 18 95.954330 Endothelial4 1 4 2 2 0 1219 768 1085 41 -1 5 1 4 2 2 1 1219 805 5 4 28.665802 .5 1 4 2 2 2 1275 803 5 5 42.189823 .5 1 4 2 2 3 1862 772 9 30 33.737259 iy5 1 4 2 2 4 1930 774 3 4 57.926620 ions 1 4 2 2 5 1963 773 17 22 88.590820 in5 1 4 2 2 6 1996 772 75 23 77.489464 hyperchot5 1 4 2 2 7 2151 770 3 4 88.454865 ia5 1 4 2 2 8 2170 769 14 18 94.830414 is5 1 4 2 2 9 2191 768 113 22 93.260979 reversed5 1 4 2 2 10 2268 764 19 31 92.482338 by5 1 4 2 2 11 2296 764 12 31 53.182831 a3 1 4 3 0 0 1131 793 1173 41 -1 4 1 4 3 1 0 1131 793 1173 41 -1 5 1 4 3 1 1 1131 811 30 23 96.969048 to5 1 4 3 1 2 1173 806 126 26 95.881439 maintains 1 4 3 1 3 1312 802 79 26 96.378029 these5 1 4 3 1 4 1404 799 103 27 96.524902 results.5 1 4 3 1 5 1855 797 90 20 41.688885 nisiritional5 1 4 3 1 6 1951 799 66 22 96.296982 products 1 4 3 1 7 2023 793 281 26 91.718346 designed5 1 4 3 1 8 2107 784 18 41 89.689026 tn5 1 4 3 1 9 2134 784 63 41 95.821457 enhances 1 4 3 1 10 2206 784 45 41 90.930016 nitric5 1 4 3 1 11 2261 784 45 41 51.737980 aside2 1 5 0 0 0 1147 819 1212 184 -1 3 1 5 1 0 0 1147 819 1212 184 -1 4 1 5 1 1 0 1857 819 398 28 -1 5 1 5 1 1 1 1857 824 69 23 84.773087 activity.5 1 5 1 1 2 1945 823 86 18 53.914093 Candiovuse5 1 5 1 1 3 2036 823 47 20 94.385735 Drugs 1 5 1 1 4 2089 821 44 18 90.139809 Ther,5 1 5 1 1 5 2140 820 63 18 80.043198 2000.0.5 1 5 1 1 6 2209 819 46 19 25.279274 1758.4 1 5 1 2 0 1294 845 895 36 -1 5 1 5 1 2 1 1294 877 5 4 8.246269 :5 1 5 1 2 2 1496 872 4 5 41.708721 .5 1 5 1 2 3 1859 850 15 18 78.999428 2.5 1 5 1 2 4 1881 850 40 17 72.331833 Daa5 1 5 1 2 5 1927 848 84 18 59.748463 available.5 1 5 1 2 6 2017 847 56 18 93.241661 Cooke5 1 5 1 2 7 2080 847 72 17 89.725891 Pharms.5 1 5 1 2 8 2158 845 31 17 92.091637 Inc.4 1 5 1 3 0 1147 875 510 31 -1 5 1 5 1 3 1 1147 886 21 18 27.871506 wv5 1 5 1 3 2 1199 878 82 26 95.250748 150%5 1 5 1 3 3 1295 875 189 31 96.482864 improvements 1 5 1 3 4 1497 878 22 19 96.482864 in5 1 5 1 3 5 1532 875 125 25 96.469574 coronary4 1 5 1 4 0 1196 918 289 28 -1 5 1 5 1 4 1 1196 920 80 26 96.761635 blood5 1 5 1 4 2 1288 918 57 25 96.506882 flows 1 5 1 4 3 1358 921 127 25 96.228958 response4 1 5 1 5 0 1370 922 989 57 -1 5 1 5 1 5 1 1370 973 58 6 23.960640 a5 1 5 1 5 2 1514 970 4 6 0.000000 ;5 1 5 1 5 3 1604 969 4 4 0.000000 .5 1 5 1 5 4 1786 936 44 32 87.418030 Try5 1 5 1 5 5 1844 933 158 28 88.471939 HeartBar®5 1 5 1 5 6 2011 931 114 33 95.888367 Today...5 1 5 1 5 7 2140 930 19 26 89.788254 It5 1 5 1 5 8 2172 928 79 32 94.896957 really5 1 5 1 5 9 2263 922 96 41 96.744957 works!4 1 5 1 6 0 1151 974 476 29 -1 5 1 5 1 6 1 1151 982 21 18 0.000000 ¥5 1 5 1 6 2 1198 977 65 26 96.250252 70%5 1 5 1 6 3 1277 976 134 24 96.061409 reductions 1 5 1 6 4 1425 979 23 18 95.697151 in5 1 5 1 6 5 1461 976 94 26 96.352753 angina5 1 5 1 6 6 1569 974 58 26 96.656075 pain2 1 6 0 0 0 1154 1025 544 35 -1 3 1 6 1 0 0 1154 1025 544 35 -1 4 1 6 1 1 0 1154 1025 544 35 -1 5 1 6 1 1 1 1200 1034 66 26 96.909218 66%5 1 6 1 1 2 1280 1033 118 24 96.909218 increases 1 6 1 1 3 1410 1030 24 25 96.822823 in5 1 6 1 1 4 1447 1028 86 31 96.837341 ability5 1 6 1 1 5 1546 1030 27 22 96.105392 to5 1 6 1 1 6 1585 1025 113 26 96.105392 exercise2 1 7 0 0 0 1817 1030 521 28 -1 3 1 7 1 0 0 1817 1030 521 28 -1 4 1 7 1 1 0 1817 1030 521 28 -1 5 1 7 1 1 1 1817 1030 521 28 95.000000 2 1 8 0 0 0 1829 1073 474 31 -1 3 1 8 1 0 0 1829 1073 474 31 -1 4 1 8 1 1 0 1829 1073 474 31 -1 5 1 8 1 1 1 1829 1081 20 23 77.135315 “15 1 8 1 1 2 1859 1078 107 25 69.569862 couldn't5 1 8 1 1 3 1977 1083 61 18 96.397575 even5 1 8 1 1 4 2050 1077 62 22 96.284904 walks 1 8 1 1 5 2123 1081 17 18 95.111832 a5 1 8 1 1 6 2151 1075 56 23 95.111832 holes 1 8 1 1 7 2218 1079 31 17 96.318016 on5 1 8 1 1 8 2262 1073 41 23 96.597900 the2 1 9 0 0 0 1212 1119 1116 40 -1 3 1 9 1 0 0 1212 1119 1116 40 -1 4 1 9 1 1 0 1212 1119 1116 40 -1 5 1 9 1 1 1 1212 1126 57 27 96.731628 For5 1 9 1 1 2 1286 1123 96 27 96.609268 More5 1 9 1 1 3 1400 1121 222 28 95.928215 Information,5 1 9 1 1 4 1828 1129 57 30 96.310440 golf5 1 9 1 1 5 1892 1133 90 19 96.049438 courses 1 9 1 1 6 1993 1127 101 23 96.506233 without5 1 9 1 1 7 2106 1132 16 16 93.417114 a5 1 9 1 1 8 2132 1124 55 29 93.417114 golf5 1 9 1 1 9 2194 1125 60 22 96.433037 cart.5 1 9 1 1 10 2262 1119 66 30 96.644257 And,2 1 10 0 0 0 1200 1160 1129 96 -1 3 1 10 1 0 0 1200 1160 1129 96 -1 4 1 10 1 1 0 1200 1160 1086 34 -1 5 1 10 1 1 1 1200 1168 45 26 96.808540 Or5 1 10 1 1 2 1260 1166 39 26 96.482269 To5 1 10 1 1 3 1316 1163 106 27 92.941063 Orders 1 10 1 1 4 1439 1160 196 30 8.617737 HeartBaro,5 1 10 1 1 5 2281 1172 5 5 37.714157 ;4 1 10 1 2 0 1293 1172 1015 62 -1 5 1 10 1 2 1 1293 1206 64 26 94.156036 Calls 1 10 1 2 2 1374 1205 42 26 96.638565 Us5 1 10 1 2 3 1431 1201 115 33 96.836700 Today!5 1 10 1 2 4 1831 1181 9 23 54.464451 I5 1 10 1 2 5 1851 1177 107 26 32.804710 couldn't5 1 10 1 2 6 1968 1177 62 23 96.441223 walks 1 10 1 2 7 2041 1182 62 17 96.572113 overs 1 10 1 2 8 2113 1181 15 17 96.230682 a5 1 10 1 2 9 2140 1177 102 33 96.378410 quarters 1 10 1 2 10 2251 1172 57 23 96.905807 mile4 1 10 1 3 0 1834 1222 495 34 -1 5 1 10 1 3 1 1834 1229 102 23 96.808929 without5 1 10 1 3 2 1945 1227 60 29 96.405319 pains 1 10 1 3 3 2015 1226 24 23 96.030037 in5 1 10 1 3 4 2050 1231 42 23 96.193527 my5 1 10 1 3 5 2104 1225 60 28 96.528587 legs.5 1 10 1 3 6 2176 1224 60 22 96.795639 Now5 1 10 1 3 7 2245 1222 9 23 77.405869 |5 1 10 1 3 8 2264 1222 65 22 96.813858 have2 1 11 0 0 0 1258 1274 1045 33 -1 3 1 11 1 0 0 1258 1274 1045 33 -1 4 1 11 1 1 0 1258 1274 1045 33 -1 5 1 11 1 1 1 1258 1280 53 21 96.651031 Free5 1 11 1 1 2 1322 1278 92 25 95.765915 Samples 1 11 1 1 3 1425 1276 33 21 93.283310 Kits 1 11 1 1 4 1467 1274 119 23 87.889671 Avoilable.5 1 11 1 1 5 1834 1285 34 18 96.393776 no5 1 11 1 1 6 1879 1277 82 30 90.580559 pain.”5 1 11 1 1 7 1971 1288 28 4 91.810333 —5 1 11 1 1 8 2010 1279 55 24 96.946999 Gary5 1 11 1 1 9 2074 1276 113 28 86.313683 Martinelli,5 1 11 1 1 10 2197 1275 106 22 91.267563 California2 1 12 0 0 0 1160 1310 524 32 -1 3 1 12 1 0 0 1160 1310 524 32 -1 4 1 12 1 1 0 1160 1310 524 32 -1 5 1 12 1 1 1 1160 1321 42 21 73.922844 Ash5 1 12 1 1 2 1212 1319 28 21 96.998924 Us5 1 12 1 1 3 1248 1318 71 21 97.010361 About5 1 12 1 1 4 1328 1315 45 22 96.885132 Ours 1 12 1 1 5 1380 1313 83 26 95.022980 Specials 1 12 1 1 6 1471 1312 101 21 96.984459 Discounts 1 12 1 1 7 1580 1310 104 26 96.356903 Program.2 1 13 0 0 0 1828 1315 519 28 -1 3 1 13 1 0 0 1828 1315 519 28 -1 4 1 13 1 1 0 1828 1315 519 28 -1 5 1 13 1 1 1 1828 1315 519 28 95.000000 2 1 14 0 0 0 1154 1414 775 41 -1 3 1 14 1 0 0 1154 1414 775 41 -1 4 1 14 1 1 0 1154 1414 775 41 -1 5 1 14 1 1 1 1154 1431 56 24 91.028664 Calls 1 14 1 1 2 1227 1427 164 26 90.499786 HeartBare5 1 14 1 1 3 1404 1425 54 23 96.686951 Toll5 1 14 1 1 4 1475 1424 66 23 95.407356 Free5 1 14 1 1 5 1583 1423 7 21 86.000381 15 1 14 1 1 6 1624 1420 71 23 11.090126 &865 1 14 1 1 7 1725 1417 73 24 62.037590 8085 1 14 1 1 8 1829 1414 100 24 94.649017 68382 1 15 0 0 0 0 56 1058 1510 -1 3 1 15 1 0 0 0 56 1058 1510 -1 4 1 15 1 1 0 0 56 1058 1510 -1 5 1 15 1 1 1 0 56 1058 1510 95.000000 2 1 16 0 0 0 1017 1524 910 55 -1 3 1 16 1 0 0 1017 1524 910 55 -1 4 1 16 1 1 0 1017 1524 910 55 -1 5 1 16 1 1 1 1017 1524 910 55 95.000000 2 1 17 0 0 0 2 3224 2546 76 -1 3 1 17 1 0 0 2 3224 2546 76 -1 4 1 17 1 1 0 2 3224 2546 76 -1 5 1 17 1 1 1 2 3224 2546 76 95.000000

att step he fo ex rm d pe t | cs ° ti United Therapeu GC oR. P.O RAT att) Medicines for Life™ = = y—) -_ = wae.

——_.

— — — — = ce oO [am an) oc wd < = = = <— rofessor Baruch S.

lumberg, Ph.D.

976 Nobel Laureate in hysiology or Medicine ox Chase Distinguished cientist, Fox Chase cancer Center CERK CHASE Professor Raymond A. Dwek, F.R.S.

Director, University of Oxford Glycobiology Institute, Chairman of the Department of Biochemistry Louis J. ignarro, Ph.D. Lewis Rubin, M.D. Sir John Vene, D.Sc., F.R-S. Professor, Molecular and Director, Pulmonary/Critical 1982 Nobel Laureate in Medical Pharmacology Care Division Physiology or Medicine Jerome J. Belzer, M.D., University of California, Chairman of the Distinguished Professor of: - San Diego Scientific Advisory Board Pharmacology, UCLA 1998 Nobel Laureate in Physiology or: : ar Medicine UCSD Medico! Center LUA e a s RESEARCH FOUNDATION United Therapeutics benefits from having an advisory board that comprises a renowned group of experts. Chaired by the discoverers of the prostacyclin molecule, our Scientific Advisory Board includes three Nobel Laureates: Sir John Vane, D.Sc., F.R.S., co-discoverer of prostacyclin; Professor Baruch S. Blumberg, Ph.D., discoverer of the hepatitis B virus marker; and Professor Louis J. ignarro, Ph.D., co-discoverer of nitric oxide's role in the cardiovascular system. Our Scientific Advisory Board provides valuable vision, product guidance, and industry contacts. The Board's medical acumen is provided by thought-leaders Robyn J. Barst, M.D., Professor of Pediatrics, Columbia University College of Physicians and Surgeons, Director, Pulmonary Hypertension Center, New York Presbyterian Hospital; Professor John Eric Deanfield, M.B., BChir, F.R.C.P., Senior Lecturer at St. Bartholomew's Hospital, London; Professor Raymond A. Dwek, FR.S., Director, University of Oxford Glycobiology Institute, Chairman of the Department of Biochemistry; Professor Victor J. Dzau, M.D., Chairman of the Department of Medicine of Brigham & Women's Hospital, Harvard Medical School; Professor Salvador Moncada, M.D., Ph.D., D.Sc., co-discoverer of prostacyclin and Vice Chairman of the Scientific Advisory Board; Urban Ramstedt, Ph.D., Virus Research Institute in Cambridge, Massachusetts; Lewis Rubin, M.D., Director, Pulmonary/Critical Care Division, University of California, San Diego; and Professor Sir Magdi Yacoub, M.D., F.A.C.S., England's National Heart and Lung Institute. For Immediate Release For Further Information Contact:

Therese Fergo 301-608-9292 Email [email protected] UNITED THERAPEUTICS ACQUIRING COOKE PHARMA, EXPANDING INTO ANGINA AND CORONARY ARTERY DISEASE Silver Spring, MD and Belmont, CA, December 18, 2000 — United Therapeutics Corporation (NASDAQ: UTHR) announced today that its wholly owned subsidiary, Unither Pharmaceuticals, Inc., 1s acquiring all of the assets of Cooke Pharma, Inc., the exclusive maker of the HeartBar®, the first and only medical food for angina and other cardiovascular conditions. Medical foods are regulated by the FDA. The HeartBar relieves the symptoms of heart disease by increasing the diameter of blood vessels and thereby increasing blood flow. Clinical studies conducted by Cooke Pharma have demonstrated convincingly the ability of the HeartBar to reduce painful symptoms of cardiovascular disease, increase exercise tolerance and improve the quality of life. Privately held Cooke Pharma is the only company that owns the patent rights to use the HeartBar’s key ingredient, arginine, in a food product for cardiovascular diseases. Cooke ~ Pharma sold over four million HeartBars as an over-the-counter product during 1999- 2000. oo The HeartBar, which is included in the Physicians Desk Reference, increases the relaxing effect of nitric oxide produced by blood vessels. In 1998, three American scientists received the Nobel Prize for their discovery that healthy blood vessels make nitric oxide, which keeps them relaxed and open. Randomized, double-blinded clinical studies published in leading medical journals and presented at the 2000 American Heart Association conference have shown that the HeartBar reduces angina and significantly improves exercise ability as compared to placebo. Cooke Pharma has other products in development based on its issued and pending patents targeting those at risk of heart disease and for overall cardiovascular health. The Cooke Pharma Scientific Advisory Board includes two Nobel Laureates in Medicine, - Sir John Vane and Dr. Louis Ignarro, as well as the Chairman of Medicine of Harvard ~ Medical School, Dr. Victor J. Dzau, among. ot er experts in Cardiology. ‘The founder of Cooke Pharma, Dr. John Cooke, is the Director of Vascular Medicine at the Falk Center for Cardiovascular Research at Stanford University. With5 1 9 1 1 2 447 2702 58 36 96.686150 thes 1 9 1 1 3 520 2698 211 49 96.790291 acquisitions 1 9 1 1 4 745 2694 43 38 96.955254 of5 1 9 1 1 5 797 2691 127 39 96.990982 Cooke5 1 9 1 1 6 939 2681 176 57 88.068344 Pharma's5 1 9 1 1 7 1130 2665 213 67 95.181610 impressive5 1 9 1 1 8 1356 2668 219 52 96.930672 technology5 1 9 1 1 9 1581 2662 188 56 96.906105 platform,5 1 9 1 1 10 1784 2655 136 63 96.372574 United4 1 9 1 2 0 321 2719 1804 88 -1 5 1 9 1 2 1 321 2759 249 48 96.644951 Therapeutics5 1 9 1 2 2 586 2756 101 48 96.793976 gains5 1 9 1 2 3 700 2766 18 24 96.444870 a5 1 9 1 2 4 731 2749 209 51 96.444870 pioneering5 1 9 1 2 5 953 2742 153 41 96.611649 medical5 1 9 1 2 6 1122 2739 92 38 96.969727 foods 1 9 1 2 7 1227 2736 150 53 96.897087 products 1 9 1 2 8 1386 2733 90 36 96.009064 with5 1 9 1 2 9 1489 2728 167 49 96.009064 dynamics 1 9 1 2 10 1671 2725 141 49 97.008385 growths 1 9 1 2 11 1824 2720 175 51 59.890060 potential5 1 9 1 2 12 2015 2719 110 40 39.915012 in.4 1 9 1 3 0 323 2777 1763 79 -1 5 1 9 1 3 1 323 2821 58 34 96.217262 thes 1 9 1 3 2 396 2818 68 38 96.908836 $135 1 9 1 3 3 478 2815 128 37 96.038055 billions 1 9 1 3 4 619 2815 96 35 96.038055 hearts 1 9 1 3 5 729 2811 135 36 96.851379 diseases 1 9 1 3 6 880 2804 147 41 96.568115 market,5 1 9 1 3 7 1042 2801 38 35 96.860100 as5 1 9 1 3 8 1094 2797 86 37 96.462334 wells 1 9 1 3 9 1197 2806 39 25 95.631523 as5 1 9 1 3 10 1249 2795 59 35 95.631523 thes 1 9 1 3 11 1321 2790 113 48 96.123306 larger5 1 9 1 3 12 1445 2788 140 47 96.123306 markets 1 9 1 3 13 1597 2785 45 37 96.979317 of5 1 9 1 3 14 1651 2785 47 37 96.970619 605 1 9 1 3 15 1711 2782 147 38 95.464622 millions 1 9 1 3 16 1872 2777 214 39 95.781906 Americans4 1 9 1 4 0 325 2833 1754 80 -1 5 1 9 1 4 1 325 2878 83 35 96.757484 who5 1 9 1 4 2 422 2886 56 26 96.903793 ares 1 9 1 4 3 493 2880 33 29 96.639183 at5 1 9 1 4 4 538 2873 74 36 96.594658 risks 1 9 1 4 5 626 2870 44 37 96.802773 of5 1 9 1 4 6 679 2866 212 46 96.802773 developing5 1 9 1 4 7 902 2864 100 35 94.849403 hearts 1 9 1 4 8 1017 2855 173 44 93.337326 disease, said Dr. Barry Kanarek, President and COO. of Unither Pharmaceuticals. Cooke5 1 9 1 5 5 1055 2914 155 41 96.350082 Pharma5 1 9 1 5 6 1224 2908 258 47 96.591690 complements5 1 9 1 5 7 1495 2901 135 39 96.920944 United5 1 9 1 5 8 1642 2893 269 51 0.000000 Therapeutics’5 1 9 1 5 9 1924 2888 155 42 96.166489 mission2 1 10 0 0 0 1702 3118 6 12 -1 3 1 10 1 0 0 1702 3118 6 12 -1 4 1 10 1 1 0 1702 3118 6 12 -1 5 1 10 1 1 1 1702 3118 6 12 59.891476 ‘2 1 11 0 0 0 0 3292 2550 8 -1 3 1 11 1 0 0 0 3292 2550 8 -1 4 1 11 1 1 0 0 3292 2550 8 -1 5 1 11 1 1 1 0 3292 2550 8 95.000000 to develop highly effective, clinically proven therapies to combat cardiovascular disease,” Dr. Kanarek said.

The acquisition is structured as a taxable stock-for-assets purchase with a residual royalty stream. United Therapeutics will issue approximately 300,000 shares of its common stock to Cooke Pharma, subject to adjustment within a year, and Unither Pharmaceuticals agreed to pay a single-digit cash royalty to Cooke Pharma on sales of Cooke Pharma _ products up to an additional $49 million, subject to possible reduction. Unither Pharmaceuticals will create a new wholly owned subsidiary which will operate under the Cooke Pharma name and will be managed by Cooke Pharma's existing management team. Closing of the asset purchase agreement is contingent upon several consents and approvals, including approval of the transaction by Cooke Pharma's shareholders by December 31, 2000.

This5 1 4 1 1 2 383 1220 217 38 96.698456 transactions 1 4 1 1 3 613 1216 75 36 96.484528 will5 1 4 1 1 4 703 1219 116 30 96.779823 creates 1 4 1 1 5 834 1222 19 23 95.758553 a5 1 4 1 1 6 867 1207 154 43 95.758553 winning5 1 4 1 1 7 1035 1201 248 38 96.742661 combinations 1 4 1 1 8 1294 1198 76 35 96.760483 that5 1 4 1 1 9 1385 1206 70 24 96.760483 cans 1 4 1 1 10 1467 1190 138 39 96.076187 benefits 1 4 1 1 11 1617 1187 163 38 96.667976 millions5 1 4 1 1 12 1795 1184 45 36 96.961250 of4 1 4 1 2 0 268 1233 1720 87 -1 5 1 4 1 2 1 268 1289 206 30 96.384903 consumers5 1 4 1 2 2 489 1276 71 36 96.384903 ands 1 4 1 2 3 573 1273 151 47 97.003212 patients5 1 4 1 2 4 737 1269 87 35 97.013550 who5 1 4 1 2 5 836 1267 91 34 96.999344 have5 1 4 1 2 6 942 1274 38 24 96.843010 or5 1 4 1 2 7 994 1272 53 25 96.313202 ares 1 4 1 2 8 1062 1267 33 28 96.967941 at5 1 4 1 2 9 1110 1258 75 37 96.974434 risks 1 4 1 2 10 1200 1256 45 36 96.768509 of5 1 4 1 2 11 1254 1251 222 47 97.003395 developing5 1 4 1 2 12 1488 1249 100 35 96.753738 hearts 1 4 1 2 13 1602 1245 67 36 96.753738 ands 1 4 1 2 14 1683 1241 120 36 94.826820 vessels 1 4 1 2 15 1819 1233 169 55 82.476044 disease, said John Cooke. Both5 1 4 1 3 5 747 1323 135 38 96.645752 United5 1 4 1 3 6 894 1317 248 47 97.001366 Therapeutics5 1 4 1 3 7 1157 1314 71 44 95.739357 ands 1 4 1 3 8 1242 1311 126 36 95.739357 Cooke5 1 4 1 3 9 1383 1309 156 35 96.204460 Pharma5 1 4 1 3 10 1554 1304 100 36 96.757874 shares 1 4 1 3 11 1668 1312 21 24 95.815681 a5 1 4 1 3 12 1704 1306 122 37 95.815681 strong4 1 4 1 4 0 273 1347 1686 83 -1 5 1 4 1 4 1 273 1392 246 38 95.864746 commitments 1 4 1 4 2 531 1395 39 28 96.246460 to5 1 4 1 4 3 585 1383 204 47 96.993416 improving5 1 4 1 4 4 803 1374 278 40 96.604111 cardiovascular5 1 4 1 4 5 1092 1370 125 37 96.590630 health5 1 4 1 4 6 1232 1367 67 36 96.668060 ands 1 4 1 4 7 1314 1364 132 44 96.976471 savings 1 4 1 4 8 1460 1362 104 35 96.468460 lives.5 1 4 1 4 9 1590 1359 67 34 96.839447 We5 1 4 1 4 10 1670 1355 143 36 97.006882 believes 1 4 1 4 11 1827 1347 132 53 96.031586 United2 1 5 0 0 0 275 1406 1697 136 -1 3 1 5 1 0 0 275 1406 1697 136 -1 4 1 5 1 1 0 275 1406 1697 87 -1 5 1 5 1 1 1 275 1446 251 47 96.793724 Therapeutics5 1 5 1 1 2 538 1444 68 35 96.877602 has5 1 5 1 1 3 619 1442 58 34 97.011986 thes 1 5 1 1 4 691 1438 132 40 97.008499 vision,5 1 5 1 1 5 838 1432 138 37 96.407974 clinical5 1 5 1 1 6 990 1427 174 47 96.593956 expertise5 1 5 1 1 7 1181 1425 68 35 95.622894 ands 1 5 1 1 8 1263 1429 189 30 95.622894 resources5 1 5 1 1 9 1467 1424 39 29 96.269089 to5 1 5 1 1 10 1518 1415 106 36 96.314423 makes 1 5 1 1 11 1638 1413 58 35 93.293274 thes 1 5 1 1 12 1710 1410 181 41 92.555702 HeartBar5 1 5 1 1 13 1905 1406 67 36 96.999367 anda 1 5 1 2 0 278 1467 1373 75 -1 5 1 5 1 2 1 278 1507 114 35 96.585693 futures 1 5 1 2 2 407 1499 250 39 96.153137 formulations5 1 5 1 2 3 669 1494 137 37 97.001488 markets 1 5 1 2 4 820 1490 135 39 90.612915 leaders5 1 5 1 2 5 969 1482 238 42 85.495522 worldwide,”5 1 5 1 2 6 1223 1476 195 39 96.597321 continued5 1 5 1 2 7 1432 1476 65 34 96.503448 Dr.5 1 5 1 2 8 1513 1467 138 51 96.929237 Cooke.2 1 6 0 0 0 282 1575 1657 192 -1 3 1 6 1 0 0 282 1575 1657 192 -1 4 1 6 1 1 0 282 1575 1645 80 -1 5 1 6 1 1 1 282 1620 63 35 93.222321 Dr.5 1 6 1 1 2 359 1614 164 38 92.578667 Kanarek5 1 6 1 1 3 537 1609 128 42 96.284943 added,5 1 6 1 1 4 680 1606 91 36 94.414139 Led by Dr. Cooke, Cooke Pharma has a respected record of. . combining medical science with product innovation. We expect the HeartBar could become an important weapon against heart disease." Through his own extensive research at Stanford University, Dr. Cooke pioneered the use of arginine and other nutrients to improve vessel function and relieve symptoms in . patients with peripheral vascular disease and with coronary artery disease. Dr. Cooke formulated these nutrients into medical foods and founded Cooke Pharma in 1995 to produce and market the products. The HeartBar is available over-the-counter at pharmacies nationwide. Cooke Pharma has plans to launch a second product, a drink, in 2001. , United Therapeutics is a biotechnology company focused on combating cardiovascular, inflammatory and infectious diseases with unique therapeutic products. Fx T e.d VOLUME 136 Decision and Order DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the respondents named in the caption hereof, and the respondents having been furnished thereafter with a copy of a draft of complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge respondents with violation of the Federal Trade Commission Act; and The respondents, their attorneys, and counsel for Federal Trade Commission having thereafter executed an agreement containing a consent order, an admission by the respondents of all the jurisdictional facts set forth in the aforesaid draft of complaint, a statement that the signing of said agreement is for settlement purposes only and does not constitute an admission by respondents that the law has been violated as alleged in such complaint, or that the facts as alleged in such complaint, other than jurisdictional facts, are true and waivers and other provisions as required by the Commission’s Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the respondents have violated the said Act, and that complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of thirty (30) days for the receipt and consideration of public comments, now in further conformity with the procedure prescribed in § 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings and enters the following order: 1. Respondent Unither Pharma, Inc. (“Unither Pharma”) is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910. Unither Pharma is a wholly owned subsidiary of Unither Pharmaceuticals, VOLUME 136 Decision and Order Inc., which is wholly owned by respondent United Therapeutics Corporation.

2. Respondent United Therapeutics Corporation (“United Therapeutics”) is a Delaware corporation with its principal office or place of business at 1110 Spring St., Silver Spring, Maryland 20910.

3. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the respondents, and the proceeding is in the public interest.

ORDER DEFINITIONS For purposes of this order, the following definitions shall apply:

1. “Competent and reliable scientific evidence” shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. 2. Unless otherwise specified, “respondents” shall mean United Therapeutics Corporation, Unither Pharma, Inc., and their successors, assigns, officers, agents, representatives and/or employees.

3. “Commerce” shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44.

4. “Food” and “drug” shall mean as defined in Section 15 of the Federal Trade Commission Act, 15 U.S.C. § 55, and “over-thecounter” shall mean available without a prescription. VOLUME 136 Decision and Order 5. “L-Arginine product” means any food, over-the-counter drug, medical food, or dietary supplement which contains as an ingredient the amino acid L-arginine.

I.

IT IS ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of HeartBar, HeartBar Plus, HeartBar Sport (collectively “HeartBar”), or any other L-Arginine product used in or marketed for: (1) the treatment, cure, or prevention of cardiovascular disease, or (2) the improvement of cardiovascular or vascular function, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, that such product:

A. substantially decreases leg pain for people with cardiovascular disease;

B. reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, estrogen deficiency, or any other medical condition or health risk; C. prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, or reduces the risk of developing cardiovascular disease; D. reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, or for medications, such as nitroglycerin, in patients with cardiovascular disease; or E. improves endurance, circulation, and energy for the general population;

unless, at the time the representation is made, respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation.

VOLUME 136 Decision and Order II.

IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising,promotion, offering for sale, sale, or distribution of any food, medical food, or dietary supplement used in or marketed for: (1) the treatment, cure, or prevention of cardiovascular disease, or (2) the improvement of cardiovascular or vascular function, shall not make any representation, in any manner, expressly or by implication, about the health benefits, performance, or efficacy of such product, unless, at the time the representation is made, respondents possess and rely uponcompetentandreliable scientific evidence that substantiates the representation.

III.

IT IS FURTHER ORDERED that respondents, directly or through any corporation, subsidiary, division, or other device, in connectionwith the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any food, medical food, or dietary supplement used in or marketed for: (1) the treatment, cure, or prevention of cardiovascular disease, or (2) the improvement of cardiovascular or vascular function, shall not misrepresent, in any manner, expresslyorbyimplication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. IV.

Nothing in this order shall prohibit respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration. VOLUME 136 Decision and Order V.

Nothing in this order shall prohibit respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990.

VI.

IT IS FURTHER ORDERED that respondents shall, within thirty (30) days after the date of service of this order, send by first class certified mail, return receipt requested, to each distributor, seller, or purchaser for resale of any HeartBar product with whom respondents, or their agents, successors, or assigns, have done business since January 1, 2001, notice of this order in the form attached as Attachment A. The mailing shall not include any other documents.

In the event that respondents receive any information that, subsequent to its receipt of notice of this order, any distributor, seller, or purchaser for resale is using or disseminating any advertisement or promotional material containing claims about HeartBar prohibited by Parts I, II, or III of this order, respondents shall: (1) immediately send such distributor, seller, or purchaser for resale a letter requesting that it stop using or disseminating any such advertisement or promotional material and notifying it that any such use or dissemination will be reported to the Commission; and (2) within thirty (30) days notify the Associate Director for Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, in writing, of the identity of such distributor, seller, or purchaser for resale and its use or dissemination of any advertisement or promotional material containing claims about HeartBar prohibited by Parts I, II, or III of this order. VOLUME 136 Decision and Order VII.

IT IS FURTHER ORDERED that respondents, and their successors and assigns, shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon request make available to the Federal Trade Commission for inspection and copying: A. All advertisements and promotional materials containing the representation including videotape recordings of all such broadcast advertisements;

B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations. VIII.

IT IS FURTHER ORDERED that respondents, and their successors and assigns, shall deliver a copy of this order to all current and future officers, directors, and managers, and to all current and future employees, and agents having responsibilities with respect to the subject matter of this order, and shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to current personnel within thirty (30) days after the date of service of this order, and, for a period of five (5) years after the date of service of this order, to future personnel within thirty (30) days after the person assumes such position or responsibilities. VOLUME 136 Decision and Order IX.

IT IS FURTHER ORDERED that respondents, and their successors and assigns, shall notify the Commission at least thirty (30) days prior to any change in the corporation that may affect compliance obligations arising under this order, including but not limited to a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor corporation; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the corporate name or address. Provided, however, that, with respect to any proposed change in the corporation about which respondents learn less than thirty (30) days prior to the date such action is to take place, respondents shall notify the Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580.

X.

IT IS FURTHER ORDERED that respondents, and their successors and assigns, shall, within sixty (60) days after the date of service of this order, and at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with this order. XI.

IT IS FURTHER ORDERED that this order will terminate on July 22, 2023, or twenty (20) years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes VOLUME 136 Decision and Order later; provided, however, that the filing of such a complaint will not affect the duration of:

A. Any Part in this order that terminates in less than twenty (20) years;

B. This order's application to any respondent that is not named as a defendant in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that the respondents did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that the order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal. By the Commission.

VOLUME 136 Decision and Order ATTACHMENT A BY CERTIFIED MAIL, RETURN RECEIPT REQUESTED [To be printed on letterhead of Unither Pharma, Inc. or United Therapeutics Corporation] [date] Dear [distributor, seller, or purchaser for resale]: We write to announce Unither Pharma’s new advertising policy for HeartBar related products. As you may be aware, on ___________, 2003, the Federal Trade Commission (“FTC”) announced a settlement and consent agreement with Unither Pharma, Inc. and United Therapeutics Corporation related to the marketing of HeartBar products. This agreement requires that the claims we make when marketing HeartBar products must be accurate and grounded in competent and reliable scientific evidence.

We are committed to obeying fully the requirements of this settlement agreement with the FTC, while, at the same time, vigorously supporting sales of HeartBar products. To better explain how this advertising policy change may affect you, we briefly summarize the agreement with the FTC and ask for your full cooperation in ensuring that HeartBar products are sold in a manner consistent with this policy.

The Settlement Agreement In its complaint accompanying the consent order, the FTC alleged, among other things, that our advertisements made unsubstantiated claims that: (1) HeartBar substantially decreases leg pain for people with cardiovascular disease; (2) HeartBar reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, or estrogen deficiency; (3) HeartBar prevents age-related vascular problems, including “hardening of the VOLUME 136 Decision and Order arteries” and plaque formation, and reduces the risk of developing cardiovascular disease; (4) HeartBar reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, and medications, such as nitroglycerin, in patients with cardiovascular disease; and (5) HeartBar Sport improves endurance and energy for the general population.

The FTC’s complaint further alleged that our advertisements falsely claimed that clinical studies, research, and/or trials show that: (1) HeartBar decreases angina pain, including by as much as 70% within two weeks; (2) HeartBar decreases leg pain while walking or exercising, including by as much as 66% within two weeks, for people with peripheral artery disease; (3) HeartBar reverses the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart; and (4) HeartBar Sport improves endurance and energy for the general population. We deny the FTC’s complaint allegations and do not admit to any wrongdoing or violation of law. However, in order to resolve this matter, Unither Pharma, Inc. and United Therapeutics Corporation have entered into a settlement agreement with the FTC. Pursuant to the consent agreement, Unither Pharma, Inc. and United Therapeutics Corporation are required to request that our distributors and sellers stop using or distributing advertisements, packaging, or promotional materials containing claims challenged by the FTC. We are sending you this letter, because you are one of our distributors, sellers, or purchasers for resale.

Unless we have competent and reliable scientific evidence to support our claims, the consent agreement prohibits us from representing that any HeartBar product: • substantially decreases leg pain for people with cardiovascular disease;

• reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, estrogen deficiency, or any VOLUME 136 Decision and Order other medical condition or health risk; • prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, or reduces the risk of developing cardiovascular disease; • reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, or for medications, such as nitroglycerin, in patients with cardiovascular disease; or • improves endurance, circulation, and energy for the general population.

The consent agreement also prohibits us from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research regarding any HeartBar product.

Our Commitment Unither Pharma, Inc. and United Therapeutics Corporation are committed to the continued study of the health benefits of the HeartBar product and L-arginine through scientifically valid, wellcontrolled clinical testing. It is the companies’ hope that such testing will produce competent and reliable scientific evidence necessary to support additional claims that supplemental Larginine provides certain health benefits. However, Unither Pharma, Inc. and United Therapeutics Corporation wish to emphasize that it is critically important that claims made pertaining to such health benefits only be made based upon such competent and reliable scientific evidence. Your Assistance We request your assistance in complying with the consent agreement. Please discontinue using, distributing, or relying on any of our advertising or promotional material, including VOLUME 136 Decision and Order packaging, for any HeartBar product that makes any of the claims mentioned above. Please also notify any of your customers who resell these products and who may have such materials to discontinue using such promotional materials. If we receive information that you are continuing to use materials that do not comply with the consent agreement, we will notify the FTC of your failure to comply with this request. We very much look forward to our mutual continued success and thank you very much for your assistance. Sincerely, [name] President Unither Pharma, Inc./United Therapeutics Corporation VOLUME 136 Analysis Analysis of Proposed Consent Order to Aid Public Comment The Federal Trade Commission has accepted, subject to final approval, an agreement containing a consent order from Unither Pharma, Inc. and its parent company, United Therapeutics Corporation (collectively “Unither”).

The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.

This matter involves allegedly misleading representations about Unither’s HeartBar products, chewy food bars and powders enriched with L-Arginine, vitamins, and minerals. HeartBar’s labeling describes the product as the only “medical food” for the dietary management of heart and vascular disease. According to the FTC complaint, Unither failed to have substantiation for the claims that HeartBar: (1) substantially decreases leg pain for people with cardiovascular disease; (2) reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, or estrogen deficiency; (3) prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, and reduces the risk of developing cardiovascular disease; (4) reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, and medications, such as nitroglycerin, in patients with cardiovascular disease; and (5) improves endurance and energy for the general population. Among other reasons, several of the representations are not supported by any clinical studies on humans. Other representations are based on results reported in studies that suffer from various flaws, including the failure to account for the placebo effect and extremely small sample sizes, such that the VOLUME 136 Analysis experience of a single or a few subjects account for the benefits purportedly experienced by the active group as a whole. The complaint further alleges that, contrary to Unither’s claims, clinical studies, research, and/or trials do not show that HeartBar: (1) decreases angina pain, including by as much as 70% within two weeks; (2) decreases leg pain while walking or exercising, including by as much as 66% within two weeks, for people with peripheral artery disease; (3) reverses the effects of high cholesterol, smoking, diabetes, and estrogen deficiency on the heart; or (4) improves endurance and energy for the general population.

The proposed consent order contains provisions designed to prevent the Unither from engaging in similar acts and practices in the future.

Part I of the order prohibits claims that HeartBar (HeartBar, HeartBar Plus, or HeartBar Sport), or any other L-Arginine product used in or marketed for the treatment, cure, or prevention of cardiovascular disease, or the improvement of cardiovascular or vascular function: (1) substantially decreases leg pain for people with cardiovascular disease; (2) reverses damage or disease to the heart caused by high cholesterol, smoking, diabetes, estrogen deficiency, or any other medical condition or health risk; (3) prevents age-related vascular problems, including “hardening of the arteries” and plaque formation, or reduces the risk of developing cardiovascular disease; (4) reduces or eliminates the need for surgery, such as a coronary bypass or angioplasty, or for medications, such as nitroglycerin, in patients with cardiovascular disease; or (5) improves endurance, circulation, and energy for the general population, unless the claims are substantiated by competent and reliable scientific evidence. Part II of the order requires that Unither possess competent and reliable scientific evidence to support any future claims about the health benefits, performance, or efficacy of any food, medical food, or dietary supplement used in or marketed for: (1) the VOLUME 136 Analysis treatment, cure, or prevention of cardiovascular disease, or (2) the improvement of cardiovascular or vascular function. For the same products covered in Part II, Part III of the order prohibits Unither from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Parts IV and V of the order permit drug claims permitted in labeling under any tentative final or final standard promulgated by the FDA, or under any new drug application approved by the FDA, and any representation for any product permitted in labeling by the FDA pursuant to the Nutrition Labeling and Education Act of 1990.

Part VI of the order mandates that the respondents notify their distributors as to the claims the Commission has challenged and report to the Commission any distributors who continue to make claims that the Commission’s order prohibits. Parts VII, VIII, IX, and X of the order require Unither to keep copies of relevant advertisements and materials substantiating claims made in the advertisements, to provide copies of the order to certain of its personnel, to notify the Commission of changes in corporate structure, and to file compliance reports with the Commission. Part XI provides that the order will terminate after twenty (20) years under certain circumstances. The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

VOLUME 136 Complaint