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GEN News Highlights : Dec 1, 2009

Bayer Schering Pharma Receives Chinese Approval for MS Drug and Signs Anticancer Deal with Micromet

Micromet obtains $7.55 million up front and could earn another $430.22 million in milestones.

Chinese regulatory authorities approved Bayer Schering Pharma’s interferon beta-1b, Betaferon®, as a treatment for relapsing-remitting multiple sclerosis (MS). Bayer says it plans to launch the drug in the country by mid-2010.

The company separately reported exercising its option as per an agreement inked in January with Micromet to develop a new BiTE antibody against solid tumors. The decision triggers a €5 million (about $7.55 million) payment to Micromet.

Under the terms of the deal, the companies will jointly develop the BiTE candidate up to the end of Phase I trials, at which point Bayer will take over all further development and commercialization activities. Additionally, Micromet could receive milestones of up to €285 million (approximately $430.22 million) plus double-digit royalties on sales. The company will also have its R&D expenses reimbursed.

BiTE antibodies are designed to direct the body's cytotoxic T cells against tumor cells. The molecules are designed such that one BiTE arm is specific for the T-cell receptor CD3 epitope, and the other is designed to bind to the target of interest. The resulting BiTE molecule induces an immunological synapse between the T cell and tumor cell in the same manner as that observed during physiological T-cell attacks, according to Micromet.

This mediates the delivery of cytotoxic proteins directly into the tumor cell, which induces apoptosis. The company also suggests that unlike existing T-cell therapies, the BiTE approach does not require antigen presentation or other elements of T-cell recognition. It thus has the potential to circumvent immune-evasion mechanisms that tend to limit existing T-cell therapies.