Tuesday, December 16, 2008

Genzyme’s Mozobil drug gets FDA approval

By Mass High Tech staff

Global biotech firm Genzyme Corp. has received marketing approval and orphan drug designation from the U.S. Food and Drug Administration for its Mozobil drug treatment of non-Hodgkin’s lymphoma and multiple myeloma.

Mozibil is a drug designed to help increase the number of stem cells collected in a patient’s blood before being transplanted back into the body after chemotherapy. Using Mozobil, more hematopoietic cells -- a type of adult stem cell that can become any blood-related cell -- are released from the bone marrow into the bloodstream for collection making the procedure faster and less expensive, according to Genzyme. Mozobil works by blocking cell receptors that are implicated in numerous cancers and HIV. The company has reported that the drug offers the elimination of a second mobilization procedure for some patients and lowers the number of apheresis days.

In the U.S., Genzyme (Nasdaq: GENZ) plans to sell Mozobil through its transplant and oncology business unit. In Europe, the company has submitted an application for approval, which it said it expects to receive later in 2009. Genzyme has also submitted applications in Australia and Brazil, with plans to expand to 60 other countries.

Genzyme has predicted peak sales of Mozobil used in transplants to reach $400 million annually.

Genzyme acquired the drug as part of its $584 million purchase of Canada-based AnorMed Inc. in 2006, following a bidding war with Cambridge neighbor Millennium Pharmaceuticals Inc.

Founded in 1981, Genzyme is a global biotech firm focused on rare inherited disorders, kidney disease, cancer, transplant and immune disease and diagnostic testing. With 11,000 employees worldwide, Genzyme reported a 2007 profit of $481 million on revenue of $3.8 billion.