HOLZKIRCHEN, Germany, Sept. 13, 2005 (PRIMEZONE) -- 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.
About Sandoz
Sandoz, a Novartis company, is a world leader in generic pharmaceuticals and develops, manufactures and markets these medicines as well as pharmaceutical and biopharmaceutical active ingredients. As a Retail Generics company Sandoz is also operating a Business Unit with specific strategic focus -- Anti-Infectives. In 2004, Sandoz employed around 13,400 people worldwide and posted sales of USD3.0 billion. In 2005, Novartis acquired the Generic companies Hexal AG, Germany, and Eon Labs Inc., U.S. and integrated them into Sandoz. The combined company has pro forma 2004 sales of USD5.1 billion and more than 20,000 employees.
This release contains certain forward-looking statements which can beidentified by the use of forward-looking terminology, such as "should","will," or similar expressions, or by express or implied discussionsregarding potential future regulatory approvals for Omnitrope. Suchforward looking statements involve known and unknown risks,uncertainties and other factors that may cause the actual results to bematerially different from any future results, performance, orachievements expressed or implied by such statements. There can be noguarantee that the lawsuit described above will be successful, or thatOmnitrope will be approved for sale in the US. Management'sexpectations regarding Omnitrope could be affected by, among otherthings, uncertainties relating to the litigation process; uncertaintiesrelating to government regulations; as well as factors discussed inNovartis AG's Form 20-F filed with the Securities and ExchangeCommission. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those described herein as anticipated,believed, estimated or expected. Sandoz is providing the information inthis press release as of this date and does not undertake anyobligation to update any forward-looking statements contained in thispress release as a result of new information, future events orotherwise.