Friday, September 5, 2008

Biogen’s battered MS drug in cancer treatment trials

By Mass High Tech Staff

Cambridge biotech Biogen Idec and Irish drug partner Elan Corp. began testing their multiple sclerosis drug Tysabri in a phase 2/3 trial for multiple myeloma. It is the first time the immune modulating drug, specifically a recombinant, humanized monoclonal antibody, is being studied for the treatment of cancer.

The 40-patient trial is an open-label study to determine the safety and anti-tumor activity of Tysabri in patients with relapsed or refractory multiple myeloma.

According to the companies, multiple myeloma is the second most common blood cancer in the U.S. with more than 50,000 people suffering from the disease. Sales of the drug have been rising steadily, but expanding the drug’s therapeutic indication could be a financial boon for Biogen (Nasdaq: BIIB) and Elan (NYSE: ELN), given its rocky history.

The companies suffered a blow last month after reports of two cases of progressive multifocal leukoenphalopathy (PML), a serious brain infection was linked to patients taking immunosuppressants.

The news comes after just two years of the drug clearing regulatory ‘re-approval’ following Biogen’s voluntary withdrawal of it in 2005 due to other case of PML. Biogen reported it had no plans to recall the drug again.

PML is linked to the dormant — but common — JC  virus, only activated by weakened immune systems. Drugs such as Tysabri and others are designed to suppress the body’s immune system to treat diseases like MS and inflammatory disorders.

With 4,300 workers worldwide, Biogen reported 2007 net income of $638.2 million on revenue of $3.2 billion.