Omnitrope

Treatment for Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency

Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope

HOLZKIRCHEN, Germany, September 13, 2005 -- Sandoz announced today that it has filed a lawsuit against the U.S. Food and Drug Administration seeking a ruling on its pending new drug application for the human growth hormone Omnitrope.

"We believe it is important for patients and health-care providers that cost-effective follow-on protein products like Omnitrope become available as safe and effective, but less expensive and equivalent therapeutic alternatives," said Andreas Rummelt, CEO of Sandoz. "Having already acknowledged the sound science behind this application, the FDA should approve Omnitrope."

Under both the Federal Food, Drug and Cosmetic Act and the Food Prescription Drug User Fee Act, the FDA is required to either approve or reject new drug applications. Sandoz filed its application for Omnitrope in July 2003. On September 2, 2004, Sandoz announced that FDA had notified the company that the Agency was unable to reach a decision on whether to approve the company's application for Omnitrope. No action on the application has been taken since then.

The lawsuit, filed in U.S. District Court for the District of Columbia, seeks to reverse the Agency's failure to act on the Omnitrope application in accordance with the Commissioner's statutory obligations.

As a Food, Drug and Cosmetic Act biologic drug, the application for Omnitrope was filed in accordance with the 505(b)(2) regulatory pathway. At the same time, Sandoz acknowledges that the approval of most follow-on protein products, licensed under the Public Health Service Act (PHS Act) in the U.S., will require new legislation to give the FDA the authority to approve substitutable PHS Act products. The company supports a transparent public process to design suitable legislations to help enable an appropriate regulatory pathway for follow-on protein products, with an emphasis on ensuring patient safety while protecting legitimate intellectual property rights of innovator companies.

Follow-on protein products is the FDA's preferred term for "copies" of recombinant DNA-derived protein products made by companies other than the innovator and using an abbreviated approval path. These products are generally more difficult to make than traditional small-molecule generic drugs due to their greater complexity. However, using updated, state-of-the-art manufacturing and analytical processes and with an abbreviated regulatory pathway, companies like Sandoz can bring these products to market at considerable savings to patients.

Source: Novartis

Posted: September 2005

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