Nycomed and its licence holder Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that the United States District Court for the District of New Jersey has taken the matter of Wyeth and Nycomed’s motion for a preliminary injunction against Teva Pharmaceuticals USA, Inc. and Sun Pharmaceuticals Inc. in regard to a potential launch of a generic version of Protonix® (pantoprazole sodium) under advisement. The court obtained a commitment from both Teva and Sun not to launch any potential generic version of pantoprazole before September 7, 2007 while it considers the matter.
ALTANA Pharma AG, acquired by Nycomed at the beginning of this year, and Wyeth sued Teva and Sun for patent infringement based on Teva’s and Sun’s filing of Abbreviated New Dug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of Protonix® before the patent for pantoprazole, the active ingredient in Protonix®, 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. In anticipation of the end of those stays, Nycomed and Wyeth filed a motion for preliminary injunction to stop any potential launch.
About Nycomed
Nycomed provides products 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 non-audited estimated annual sales of approximately € 3.4 billion and an EBITDA of € 933.4 million (2006 results).
For more information visit www.nycomed.com
For further information
International:
Christoffer Jensen, VP Communications
Phone: +45 46 77 11 12
Mobile: +45 22 43 69 44
Germany:
Susanne Hof, Head of External Communications
Phone: +49 7531 84 30 59
Mobile: +49 151 55 00 26 65