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Wyeth Pharmaceuticals Introduces the 2005 ReFacto® Trial Prescription Program
Collegeville, Pa., May 5, 2005 Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), has announced the introduction of the 2005 ReFacto® Antihemophilic Factor (Recombinant) Trial Prescription Program. Different from last year's initiative, the 2005 program has been expanded to include additional members of the hemophilia community. Patients who receive their health care from Medicare or Medicaid and hematologists who are not associated with a hemophilia treatment center now are eligible to participate in the program.
The 2005 program is offered to allow patients and health care professionals an opportunity to gain clinical experience with ReFacto and the new ReFacto R2 Kit without incurring drug costs. The ReFacto R2 Kit is the first needle-less reconstitution device with a prefilled diluent syringe for hemophilia and was introduced in November 2004.
"We have received a positive response from the hemophilia community to this innovative program, and we are very pleased to provide it for a second year in an expanded form," said Dr. Gary L. Stiles, Executive Vice President and Chief Medical Officer of Wyeth Pharmaceuticals.
Patients in the ReFacto Trial Prescription Program will receive a one-time complimentary supply of ReFacto. There is a limited number of applications. The exact quantity of ReFacto supplied is based on the patient's age:
- <1-5 years
5,000 IUs
- 6-11 years
10,000 IUs
- 12 years and older
20,000 IUs
Patients should ask their health care professional to see if this program is right for them. Health care professionals can then contact their local Wyeth representative by calling the Wyeth Hemophilia Hotline at (888) 999-2349 to enroll patients.
About ReFacto ReFacto is indicated for the control and prevention of hemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with hemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.
As with the intravenous administration of any protein product, adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, tiredness, or symptoms of allergic reactions. The remote possibility exists for hypersensitivity to non-human mammalian proteins. Known hypersensitivity to mouse or hamster proteins may be a contraindication to the use of ReFacto. Allergic reactions such as hives, itching, difficulty breathing, rapid heart rate, light-headedness and anaphylaxis have been reported for all factor VIII products. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any of these symptoms occur.
Please see Prescribing Information at www.hemophiliavillage.com.
About Wyeth Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines, and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products, and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
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