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Nycomed and Wyeth announce launch of an own generic version of PROTONIX® – lawsuit to defend patent continues

Nycomed and its licence holder Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), today announced the U.S. launch of an own generic version of PROTONIX® (Pantoprazole) tablets, in response to the at-risk launch of generic Pantoprazole tablets by Teva Pharmaceuticals USA, Inc. Today’s launch terminates the current standstill agreement between Nycomed, Wyeth and Teva.

“Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients,” says Bernard Poussot, President and Chief Executive Officer for Wyeth. “We believe the PROTONIX® compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. 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.”

Trial is expected in the second half of 2008. Teva initiated an at-risk launch of a generic version of Pantoprazole on December 21, 2007.

Patents are crucial

“We fully support Wyeth in introducing an own generic version of Pantoprazole to the US market. While Teva’s launch-at-risk in the United States will have some impact on Nycomed’s revenue in the short-term, we are determined to counter this challenge in the courtroom as well as in the market” said Håkan Björklund, Nycomed’s Chief Executive Officer. “Patents are crucial to bringing new medicines and treatments to patients who need them. Infringing them compromises pharmaceutical innovation”, he added.

Altana Pharma AG (acquired by Nycomed at the beginning of 2007) and Wyeth sued Teva and Sun Pharmaceuticals for patent infringement based on Teva’s and Sun’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. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva’s ANDA until August 2, 2007, and Sun’s ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth’s and Nycomed’s motion for preliminary injunction. The Court did not rule on the merits of the patent, but rather the Court merely concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction.

About Wyeth

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.

About Nycomed

Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from own research and from external partners. Operating throughout Europe and in fast-growing markets such as Latin America, Russia/CIS and the Asia-Pacific region Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group had annual sales of approximately Euro 3.4 billion and an EBITDA of Euro 933.4 million (2006 results).


Source: Nycomed - 29.01.08 (P)
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Website address: https://www.gesundheitsindustrie-bw.de/en/article/press-release/nycomed-and-wyeth-announce-launch-of-an-own-generic-version-of-protonix-lawsuit-to-defend-patent-con