Fen Phen and Primary Pulmonary Hypertension News 3 Fen-Phen victims win $500,000
By Phil Milford and Dawn McCarty November 25, 2004 - A Pennsylvania jury awarded three women $500,000 for heart-valve damage caused by the Wyeth weight loss drug Fen-Phen while throwing out a fourth woman's claim, a lawyer for the women said. The Utah women, Diana Hilton, 63; Patricia Judd, 46; Lorraine Kofford, 56; and Krysti Kollman, 43, sued the Madison, New Jersey-based drug and health-care products maker in Philadelphia Court of Common Pleas in 2002 seeking more than $50,000 each. The jury rejected Hilton's claim. "We're disappointed in the verdict for Ms. Hilton, but we are very pleased with the awards to Ms. Judd, Ms. Kofford and Ms. Kollman," said plaintiffs' lawyer in a telephone interview. This was the 10th fen-phen case to be tried in the same Philadelphia court since July. Wyeth has set aside more than $16 billion to resolve cases involving the Fen-Phen mixture, which included the company's Pondimin or Redux and generic phentermine. The claims are specifically related to Pondimin, which was recalled from drugstores in 1997.
In his closing arguments, plaintiffs' lawyer Steven Kherkher told jurors that medical tests show the women have some heart-valve leakage and may need treatment that could include surgery as they get older. Jurors were asked to answer whether each plaintiff's injury was caused by the ingestion of Pondimin and, if so, what amount of damages she will suffer as a result of the injury. Shares of Wyeth, which reported $15.8 billion in sales last year, fell 18 cents to $39.12 in New York Stock Exchange composite trading at 4:18 p.m.
The case is Hilton v. Wyeth, NO. 02-1201206, Philadelphia Court of Common Pleas, Philadelphia, Pennsylvania.
36 In Fen-Phen Settlement Sue Lawyers
Thirty-six plaintiffs in a fen-phen class action settlement filed a lawsuit against their lawyers in Fayette Circuit Court last month, demanding an accounting of how the 200 million dollars in settlement funds were disbursed. The key questions in the complaint surround the Kentucky Fund for Healthy Living, a nonprofit, charitable corporation created and controlled by the lawyers. The lawsuit alleges the charity is holding up to 18 million dollars left over from the fen-phen settlement.
Japanese Approval for Tracleer in PAH Approval for all forms of Pulmonary Arterial Hypertension - Pricing discussions ongoing - Market introduction expected for early June ALLSCHWIL, SWITZERLAND - 11 April 2005 - Actelion Ltd (SWX: ATLN) announced today that the Japanese Ministry of Health, Labor and Welfare has granted formal approval for Tracleer® (bosentan) in Pulmonary Arterial Hypertension (PAH). Tracleer® has been approved for patients suffering from all forms of PAH (WHO class III and IV). Actelion is currently in discussions with reimbursement authorities to finalize pricing. Actelion expects to make Tracleer® commercially available in Japan by early June 2005. Satoshi Tanaka, M.D. and President of Actelion Japan, commented: "Actelion is very pleased that soon Japanese PAH patients will have access to our orally available dual endothelin receptor antagonist Tracleer®. Since its first market introduction in late 2001, Tracleer® has revolutionized the treatment of PAH, a serious and life-threatening disease." Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, said: "Actelion's sales and marketing organization in North America, Europe and Australia has established a strong track record of providing first-in-class medical education and support. Our well-trained and prepared 80 employees in Japan stand ready to provide the same level of service and dedication to Japanese physicians and patients." ### About Tracleer® in Pulmonary Arterial Hypertension (PAH) Tracleer®, the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Australia, Canada, Switzerland, Israel, Hong Kong, Malaysia, Singapore and Brazil as well as several other smaller territories worldwide. In Japan, Actelion obtained formal approval of Tracleer® in April 2005. Market introduction is expected in early June 2005. In clinical trials leading to the marketing approval of the drug, approximately 11% of PAH patients receiving Tracleer® experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age who do not use a reliable method of contraception, must not take Tracleer®. About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN). For further information please contact: Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil
Investor Contact Roland Haefeli +41 61 565 64 58
+1 650 624 6936
Media Contact Peter Engel +41 61 565 66 28
+1 650 624 6996
http://www.actelion.com
Fen-phen suspect to plead guilty
Gregory P. Warren of Lafayette, La., whom federal prosecutors said recruited fen-phen clients for Schwartz & Associates of Jackson, is scheduled to plead guilty June 3, in U.S. District Court in Hattiesburg. He is charged with one count of wire fraud and one count of tax evasion.
Florine Wyatt of Laurel, accused of knowingly filing a false claim, is also scheduled to make a guilty plea at the same time.
Wyatt is accused of submitting a false claim that one of her family members had used fen-phen. The family member received $18,000 before attorney fees and expenses on April 27, 2001.
Warren recruited plaintiffs on behalf of the law firm even if the plaintiff had never taken the drug, according to the U.S. attorney's office in Jackson.
Warren also is accused of failing to report on his tax return nearly $200,000 he was paid by attorneys in the 2000 for recruiting fen-phen plaintiffs.
Revatio Approved to Treat Rare and Incurable Disease
Contains same active ingredient as Viagra
KIRKLAND, QC, Aug. 22 /CNW/ - Pfizer Canada announced today that it has received Health Canada approval for Revatio(TM) (sildenafil citrate), an important new treatment for pulmonary arterial hypertension (PAH), a rare and incurable vascular disease. Sildenafil citrate is also the active ingredient in Viagra(R), Pfizer's revolutionary treatment for erectile dysfunction, which has been used by more than 27 million men worldwide since it was first introduced in 1998.
PAH is characterized by dangerously high blood pressure in the vessels that lead from the heart to the lungs. Symptoms include difficulty breathing, dizziness and fatigue. Left untreated, patients have an average survival time of less than three years from the time of diagnosis. The disease occurs on its own (primary pulmonary arterial hypertension) or may be associated with other diseases including scleroderma, congenital heart disease and HIV (secondary pulmonary arterial hypertension). It is estimated that fewer than 100,000 people worldwide and approximately 650 people in Canada - most of them women between the ages of 20 and 40 - suffer from PAH.
Revatio is a significant advance in the treatment of PAH as there are few effective options currently available and it is the only therapy approved to treat an earlier stage of the disease (Class II PAH). Patients with Class II PAH are defined as having mild limitation of physical activity and treating them early improves quality of life and significantly delays the progression to later stages of the disease, which are characterized by much more severe limitations on physical activity to the point where patients are unable to perform routine tasks without experiencing fatigue and chest pain.
"The major benefits of Revatio really relate to its high level of effectiveness and low level of side effects," explains Dr. Robert Levy, Professor, Department of Medicine, University of British Columbia. "By effectiveness, we are referring to a decrease in a patient's symptoms, improving his or her exercise capacity and decreasing the strain on the heart."
Clinical Studies Show Revatio Helps Relax Pulmonary Vessels
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Revatio has a unique mode of action that works differently than other approved PAH therapies. By inhibiting the enzyme phosphodiesterase (PDE) type 5, Revatio helps to relax the pulmonary vessels and improve blood flow. During six years of global clinical studies Revatio has been shown to reduce mean pulmonary arterial pressure and improve exercise capacity and cardiac function. A large randomized, double-blind, placebo-controlled study involving 277 patients with PAH published in the New England Journal of Medicine in November 2005 measured the exercise capability of patients after 12 weeks of treatment. Patients were randomized to receive Revatio 20 mg, 40 mg, or 80 mg three times a day or placebo.
All three treatment groups showed highly significant improvements in the six-minute walk distance, the standard measure of efficacy in PAH trials, compared to patients who received placebo. No differences were observed among the Revatio doses studied - therefore, the approved dosage is 20 mg three times daily.
"Pfizer is committed to researching and developing new treatments to address unmet medical needs, including rare disorders that affect small numbers of patients," said Dr. Bernard Prigent, Vice President and Medical Director, Pfizer Canada Inc. "Revatio is an important new treatment option for a disease where patients have few alternatives."
Pfizer Canada has developed the Revatio Reimbursement Support Program (RRSP), a comprehensive program for those needing Revatio. The program is designed to simplify the insurance and reimbursement process, and provide access to Revatio for uninsured or underinsured patients. Patients can learn more about Pfizer's program by calling 1-866-424-8051.
Revatio was generally well tolerated at all doses. The most common side effects were headache, upset stomach, facial flushing, back and limb pain, diarrhea and epistaxis (nosebleeds). The use of Revatio and organic nitrates in any form, at any time, is contraindicated.
Revatio is currently available in Canadian pharmacies in a round white 20 mg pill to distinguish it from Viagra's blue diamond-shaped pill for erectile dysfunction. Revatio was approved in Europe and the United States in 2005.
About Pfizer Canada
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Pfizer Canada Inc is the Canadian operation of Pfizer Inc., the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets leading prescription medicines for humans and animals, as well as many of the world's best-known over-the-counter healthcare products. Pfizer Canada employs more than 2,000 people across the country. Canadian headquarters of Pfizer Global Pharmaceuticals Group is in Kirkland, Quebec.
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For further information: and to arrange interviews, please contact:
Catherine Héroux or Debra Quinn, Strategic Objectives, Tel: 1-866-366-7733 or
(416) 366-7735, Fax: (416) 366-2295; Michael Amos, Corporate Affairs, Pfizer
Canada Inc., Tel: (514) 693-4587
Pfizer Canada announced today that it has received Health Canada approval for Revatio(TM) (sildenafil citrate), an important new treatment for pulmonary arterial hypertension (PAH), a rare and incurable vascular disease. Sildenafil citrate is also the active ingredient in Viagra(R). (CNW Group/Pfizer Canada)
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