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Biotech / Medical : Oncothyreon -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (1667)	5/3/2001 9:24:09 AM
From: Ian@SI	Respond to of 2344

The whole story for the archive... +++++++++ Merck KGaA and Biomira Sign Global Development and US Co-Promotion Agreement for Breast and Lung Cancer Therapeutic VaccinesTwo-Product Agreement Represents One of the Largest Cancer Vaccine Collaborations DARMSTADT/GERMANY and EDMONTON, May 3, 2001 /PRNewswire via COMTEX/ -- Merck KGaA and Biomira Inc. (NASD: BIOM) (TSE:BRA) today announced that they have entered into a global product development and co-promotion collaboration for Biomira's two most advanced therapies - biotechnology-based vaccines, THERATOPE(R) vaccine, to treat breast cancer, the most common cancer in women, and BLP25 vaccine, for lung cancer, the leading cause of cancer deaths. THERATOPE(R) vaccine currently is being evaluated in a pivotal Phase III clinical trial for the treatment of metastatic breast cancer. The BLP25 vaccine is being tested in a Phase IIb study for the treatment of non-small cell lung cancer. The broad collaborative agreement covers the entire field of oncology for these two products. Under terms of the agreement, Merck KGaA and Biomira will jointly market products in the U.S. Merck KGaA will market the products through its U.S. affiliate, EMD Pharmaceuticals. Merck KGaA will have sole development and marketing rights in the rest of the world with the exception of Israel and the Palestinian Autonomy Area for which agreements were already in place. Biomira will retain marketing rights in Canada. Biomira will receive an up-front cash payment and equity investment. Biomira will also receive significant cash and equity investments for Biologics License Application (BLA) submissions for first and second cancer indications, on regulatory approvals for first and second indications, and for sales milestones. The total value of the agreement to Biomira is more than US$150 million in license, milestone payments and equity investments. The parties will share development costs in North America, and Merck KGaA will be responsible for clinical studies and marketing outside of North America. The two companies will share evenly the external costs associated with continued clinical development, retroactive to January 1, 2001. Biomira will manufacture the vaccines for worldwide use and will be entitled to an equal share on product sales in the U.S. and Canada, and royalties on sales for all other territories. Biomira has completed enrollment of more than 1,000 breast cancer patients in a Phase III trial with THERATOPE(R) vaccine, one of the largest trials ever undertaken with an immunotherapeutic agent in breast cancer. The trial involves approximately 120 clinical sites around the world and is designed to determine whether the vaccine can delay disease progression and increase survival in women with breast cancer that has spread to other parts of the body. Interim analyses are planned to take advantage of the potential to make THERATOPE(R) vaccine available as soon as possible should results of these analyses support an earlier filing. The U.S. Food and Drug Administration has designated THERATOPE(R) vaccine as a Fast Track Development program, and final analysis of the trial data is expected to commence in mid-2003. The BLP25 vaccine is currently being tested in a controlled, randomized Phase IIb clinical trial of 166 patients with metastatic non-small cell lung cancer. Results of earlier Phase I and II trials showed BLP25 vaccine was generally well tolerated and capable of triggering a T-cell mediated immune response against cancer cells. The current study is designed to show whether this immune response translates into clinical benefit. "Our enthusiasm for identifying products in oncology that can harness the body's own immune system in the fight against cancer led us to this important collaboration," said Merck KGaA Chief Executive Bernhard Scheuble. "We look forward to working together with Biomira in developing these technologies." Alex McPherson, MD, PhD, President and CEO of Biomira, commented: "We are extremely pleased to have entered into this agreement with Merck KGaA, who has demonstrated a global vision for the development and marketing of truly innovative biological products for the treatment of cancer. This collaboration between our two companies defines a path for Biomira to become a forward integrated biotechnology development, sales and marketing organization based on these two very promising cancer products." "This collaboration demonstrates an important step in EMD Pharmaceutical's commitment towards meeting the needs of the oncology patient and physician," said Matt Emmens, President and CEO of EMD Pharmaceuticals, the U.S. affiliate of Merck KGaA. Both cancer vaccines are synthetic mimics. Glycoprotein MUC1 is a cancer mucin, a cancer-associated marker that has been shown to inhibit T-cells and cause the immune system to ignore the presence of disease. The vaccines are designed to restore the body's immune function to recognize the foreign antigen and mount an attack against cancer cells. Merck KGaA, the world's oldest pharmaceutical company, has positioned itself to be on the cutting edge of cancer research. It has created, or licensed-in from strategic partners, a wide range of substances. The company's oncology portfolio is based on four technology platforms - monoclonal antibodies, vaccines, immunocytokines and angiogenesis inhibitors - and is represented by six projects in different stages of clinical development. EMD Pharmaceuticals, Merck KGaA's US affiliate, is a new, fully-integrated pharmaceutical company with an initial concentration on launching new products in oncology and diabetes. Located in Durham, North Carolina, EMD Pharmaceuticals focuses on meeting patient and physician needs with innovative pharmaceutical products. Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. There will be a webcast this morning regarding this announcement. The webcast can be accessed at 10:30 a.m. EDT at pressevent.com or persons may phone-in at 1-800-752-1361, or if an international call, at 415-217-0050. The webcast will be archived for up to 90 days at www.pressevent.com. Attention- News Editors: A press kit with further background information is available on the Biomira website at biomira.com and on the EMD Pharmaceuticals website at emdpharmaceuticals.com.