Thursday, Nov 1, 2001
South San Francisco, Calif. and Basel, Switzerland -- November 1, 2001 --Genentech, Inc. and Novartis Pharma AG today announced plans to submit an amendment to the Biologics License Application (BLA) for Xolair (Omalizumab) to the FDA in the fourth quarter 2002. The announcement clarifies submission expectations originally outlined by the companies in July 2001. The content of the Xolair BLA amendment will address requests for additional information made by the FDA in a Complete Response letter issued in July 2001 and the companies expect that data from ongoing trials will satisfy those requests.
"We had productive discussions with the FDA during which we reviewed our plans for responding to requests in the Complete Response letter, and have a projected goal to submit a Xolair BLA amendment to the agency by the end of 2002," said Susan D. Hellmann, MD, MPH, executive vice president, Development and Product Operations, and chief medical officer for Genentech.
Complete Response letters generally indicate that the FDA requires additional data to complete its review of an application. The July 5, 2001 Complete Response letter requested additional analyses of Xolair preclinical, clinical and pharmacokinetic information. Genentech and Novartis submitted the original BLA package on June 6, 2000.
"We have a clear action plan for Xolair and are pleased with the outcome of these discussions with the FDA regarding our proposed submission strategy and timeline. We intend to move forward to reach our goal of a filing by the end of 2002," stated Joerg Reinhardt, Head of Development, Novartis Pharma. The companies are seeking approval of Xolair for allergic asthma in adults and adolescents, greater than 12 years of age, subject to final review and approval by the FDA.
Xolair is a monoclonal antibody to IgE in development under an agreement among Novartis Pharma AG, Genentech, Inc. and Tanox, Inc. It is the first agent to specifically target IgE. By binding to IgE antibodies, Xolair prevents IgE from attaching to mast cells. Without IgE bound to mast cells, the presence of allergen will not cause the release of chemical mediators like histamine and leukotrienes, which lead to the symptoms and inflammation of allergic asthma. In trials to date, Xolair has been administered as a subcutaneous (under the skin) injection every two to four weeks, at a dose depending on patients' body weight and IgE levels. If approved, Xolair will be a first-in-class drug, and the first product to specifically target allergic asthma in adults.
Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fifteen of the currently approved biotechnology products stem from or are based on Genentech science. Genentech manufactures and markets ten biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
The foregoing release contains forward-looking statements relating to the expected time frame for filing the Xolair BLA amendment with the FDA and the adequacy of such amendment in complying with the FDA's request for additional information. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the expected filing time frame will be met, that the amendment will adequately comply with the FDA's request or that the aforementioned actions will result in the commercialization of Xolair in any market. The filing time frame, the adequacy of the filing and commercialization can be affected by, among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general. 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 expected.
# # #