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Wyeth Pharmaceuticals Initiates Clinical Trial of Investigational Albumin-Free Recombinant Drug for Hemophilia A
— Implementation of a Novel Protein-Free Purification Technology Has Potential to Be an Advance in Pathogen Safety for Factor VIII Therapy —
Madison, N.J. (August 5, 2005) — Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced the initiation of a new clinical trial of an investigational recombinant factor VIII drug. This investigational drug is produced from a completely albumin-free cell culture manufacturing process. In addition, the production of this investigational drug includes a purification process free of any biologically derived materials, and the addition of a viral filtration step for added viral safety.
"We are pleased to participate in clinical trials for this investigational drug, which may provide important advances for the hemophilia community," said Craig M. Kessler, MD, Professor of Medicine and Pathology at the Georgetown University Medical Center, Washington, D.C. "Data from this study could help us identify a new treatment option to expand the therapeutic alternatives for patients who are dependent on factor VIII replacement for life."
"The development of novel technologies to manufacture this investigational factor VIII drug demonstrates Wyeth's continued leadership in providing additional recombinant viral safety to both hemophilia A and hemophilia B patients," said Dr. Gary L. Stiles, Executive Vice President and Chief Medical Officer of Wyeth Pharmaceuticals.
The clinical trial is designed to establish the safety and efficacy of the investigational factor VIII replacement therapy and to support the company's application to regulatory authorities for permission to market the drug.
The study consists of two parts: a double-blind assessment of pharmacokinetic bioequivalence to a licensed recombinant factor VIII concentrate, followed by an open-label trial of the safety and efficacy of the Wyeth investigational drug.
The purification process for the investigational drug includes a synthetic ligand, which Wyeth scientists discovered and patented with others. This synthetic ligand replaces the traditional murine (mouse) monoclonal antibody used during the purification process of all other recombinant factor VIII products. Its removal eliminates exposure of the investigational drug to any biologically derived materials during purification. In addition, none of the manufacturing processes for currently licensed recombinant factor VIII products include a viral filtration step for added viral safety.
Hemophilia is a rare, inherited blood clotting disorder for which there currently is no cure. People with hemophilia are deficient in one of the key proteins — either factor VIII (hemophilia A) or factor IX (hemophilia B) — that are vital in the clotting cascade to prevent bleeding. Both forms of hemophilia are characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with hemophilia A or hemophilia B are dependent on protein replacement therapy with factor VIII or factor IX, respectively, for life. In the United States, approximately 17,000 people have hemophilia.
Wyeth Pharmaceuticals, a division of Wyeth, 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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