HOLZKIRCHEN, Germany, September 13, 2005 - Sandoz announced today that it has filed a lawsuit against the US 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 US 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 US, 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 USD 3.0 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 USD 5.1 billion and more than 20,000 employees.
This release contains certain forward-looking statements which can be identified by the use of forward-looking terminology, such as "should", "will," or similar expressions, or by express or implied discussions regarding potential future regulatory approvals for Omnitrope. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that the lawsuit described above will be successful, or that Omnitrope will be approved for sale in the US. Management's expectations regarding Omnitrope could be affected by, among other things, uncertainties relating to the litigation process; uncertainties relating to government regulations; as well as factors discussed in the Company's Form 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Sandoz is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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For further information
Kurt Leidner,
Communications Sandoz
Tel: +49 8024 476 2591
Fax: +49 8024 476 2599
Mobile: +41 7982663163
