Wyeth Announces Launch of Own Generic Version of Protonix
- Wyeth and Nycomed Continue Lawsuit to Enforce Protonix Patent -
Madison, N.J., January 29, 2008 â€“ Wyeth (NYSE:WYE) and its business partner, Nycomed, today announced the U.S. launch of Wyethâ€™s own generic version of PROTONIXïƒ’ tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA, Inc. on December 21, 2007.Â Wyethâ€™s own generic version of PROTONIX will be distributed by Prasco starting today.Â
â€œCompound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients,â€ says Bernard Poussot, President and Chief Executive Officer for Wyeth.Â â€œWe believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics.Â Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva.â€
Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Tevaâ€™s and Sunâ€™s filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010.Â Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Tevaâ€™s ANDA until August 2, 2007, and Sunâ€™s ANDA until September 8, 2007.Â On September 6, 2007, The United States District Court for the District of New Jersey denied Wyethâ€™s and Nycomedâ€™s motion for preliminary injunction.Â The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction.Â Trial is expected in the second half of 2008.Â
Wyeth is one of the worldâ€™s largest research-driven pharmaceutical and health care products companies.Â 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.Â The Companyâ€™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, we note that the impact of generic pantoprazole tablets on sales of PROTONIX cannot be predicted with certainty and will depend upon market and competitive conditions, the outcome of future proceedings in this litigation and other factors, many of which are beyond our control.Â We and our partner Nycomed may not be able to uphold the validity of the PROTONIX patent, recover our lost profits and other damages resulting from infringing sales and/or obtain a permanent injunction against further sales of generic pantoprazole. Other 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; 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.Â We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.