Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
COLLEGEVILLE, Pa., Aug. 10 -- Wyeth Pharmaceuticals, a division of Wyeth, and Solvay Pharmaceuticals, Inc. announced today the receipt of an action letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for bifeprunox, an atypical antipsychotic that was reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The Agency stated that the drug was not approvable at this time.
The FDA stated in the letter that bifeprunox demonstrated effectiveness in the long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The Companies believe that bifeprunox offers distinct benefits for the long-term maintenance of patients with schizophrenia. The Companies will meet with the FDA to discuss study design and to assess how this additional study combined with ongoing and planned studies might support a maintenance indication.
Although the FDA acknowledged that bifeprunox separated from placebo in two short-term studies in the acute setting, the Agency concluded that the efficacy data, when compared to reference drugs, were not sufficient for approval.
The Agency also requested further information regarding human metabolism of bifeprunox, and additional information regarding a complex case of a patient who died while participating in one of the trials.
"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," says Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."
"The development of bifeprunox offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy. We continue to support the development of the compound and the approach," adds Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.
Bifeprunox, a partial dopamine agonist designed to normalize levels of chemical activity in the brain, has been studied in approximately 2,650 patients with schizophrenia at more than 200 Phase 2 and 3 clinical trial sites in the United States and throughout the world.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit http://www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide. For more information, visit http://www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2006 its consolidated sales amounted to EUR 9.4 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels.
Details are available at http://www.solvay.com.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, 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 non-prescription 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 and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, the statements in this press release regarding our expectations for bifeprunox are based on a preliminary analysis of the FDA action letter received on August 9, 2007 and our expectations as to future development and regulatory review of the product, all of which are subject to risks and uncertainties. Risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products (including bifeprunox); government cost- containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise