Friday, Mar 3, 1995
South San Francisco and San Diego, Calif. -- March 3, 1995 --Genentech, Inc. (NYSE: GNE) and IDEC Pharmaceuticals Corporation (NASDAQ: IDPH) today announced that the two companies will collaborate on the clinical development and commercialization of IDEC's anti-CD20 monoclonal antibody, IDEC-C2B8, for the treatment of non-Hodgkin's B-cell lymphomas. IDEC-C2B8 is expected to enter Phase III clinical trials by mid-1995. In addition, Genentech has the option to extend its collaboration with IDEC to include two radioconjugates, IDEC-Y2B8 and IDEC-In2B8, also for the treatment of B-cell lymphomas.
Under the terms of the agreement, Genentech will provide $9 million upfront in preferred equity investments and licensing fees, $17.5 million in additional equity funding prior to U.S. approval, and up to $30.5 million in milestone and option payments. The initial $5 million preferred stock investment will be at $5 per common stock equivalent share, and pricing of subsequent equity purchases will be based on future stock prices. The potential value of the agreement is $57 million.
In addition, Genentech and IDEC will co-promote IDEC-C2B8 in the United States and Canada, with IDEC receiving a share of profits. Genentech will retain commercialization rights throughout the rest of the world except Asia, where Genentech has certain option rights. IDEC will receive royalties on sales outside the U.S. and Canada. As part of this strategic alliance, Genentech also has executed a broad license for a proprietary gene expression system developed by IDEC.
"This agreement with IDEC to develop and commercialize IDEC-C2B8 represents a significant business opportunity and an important strategic fit with Genentech's rich pipeline of potential cancer therapies," said G. Kirk Raab, Genentech president and chief executive officer. "Working together, we will move this important project expeditiously through its pivotal trial. If the results confirm the positive Phase II findings, we are committed to making IDEC-C2B8 commercially available to the patients who can benefit from it as quickly as possible," said Raab.
"Because of their leadership and demonstrated capabilities in the development, manufacturing and marketing of biopharmaceuticals, Genentech is the ideal partner for the commercialization of IDEC-C2B8," remarked William H. Rastetter, IDEC president and chief executive officer. "The synergy between the people and the technology within the two companies has been apparent from the beginning of our collaboration discussions and will enable us to move rapidly through the next, critical stages of product development."
IDEC-C2B8 is a chimeric monoclonal antibody that binds to the CD20 antigen present on all B cells and recruits host defenses to attack and kill both malignant and normal B cells. However, unlike chemotherapy and high-dose radiation, IDEC-C2B8 has minimal toxicity and does not damage bone marrow. The granulocytes, platelets and red blood cells remain essentially normal during treatment, and normal B cells regenerate within months.
IDEC-C2B8 is being developed for certain lymphomas and leukemias characterized by excessive B-cell proliferation, including low grade and follicular non-Hodgkin's B-cell lymphomas (NHL), which afflict approximately 150,000 people in the United States with about 20,000 new diagnoses each year.
Phase II studies of IDEC-C2B8 in NHL reveal encouraging results indicating that it may provide an effective and well-tolerated treatment. IDEC, in cooperation with Genentech, will conduct a Phase III trial scheduled to begin by mid-1995 to attempt to confirm these results. Genentech and IDEC are planning additional studies with IDEC-C2B8 to support this primary indication in NHL and in other B-cell mediated cancers such as intermediate grade NHL and chronic lymphocytic leukemia.
Both Genentech and IDEC plan to manufacture IDEC-C2B8 following FDA approval, with IDEC supplying early commercial requirements.
At Genentech, IDEC-C2B8 joins two other potential cancer treatments in Phase III clinical trials -- an anti-HER2 monoclonal antibody for breast cancer and Actimmune® (interferon gamma-1b) for renal cell carcinoma. In addition, Genentech is conducting preclinical projects in cancer research, including: an anti-VEGF antibody, which may inhibit blood vessel growth in tumors; a Ras farnesyltransferase inhibitor, which may be useful in treating pancreatic and colon cancers; and thrombopoietin (TPO), which may be useful in treating the platelet destruction caused by irradiation and chemotherapy.
Genentech, Inc. is a leading international biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
IDEC Pharmaceuticals Corporation focuses on developing targeted immunotherapies for the treatment of cancer and autoimmune diseases. IDEC's products are aimed at improving the patient's therapeutic outcome while enhancing their quality of life. Designed for administration in outpatient settings, IDEC's products also offer the potential for reduced treatment costs. Products in human clinical studies include pan-B antibodies to treat B-cell lymphomas and a PRIMATIZED(TM) anti-CD4 antibody to treat autoimmune diseases being developed in collaboration with SmithKline Beecham. PRIMATIZED antibodies are the basis for two other research and development collaborations focused on the treatment of inflammatory and autoimmune diseases and on the treatment of allergic rhinitis and asthma. The company is headquartered in San Diego and is traded on the NASDAQ Exchange under the symbol IDPH.
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