Monday, November 24, 2008

Genzyme looks for New Drug approval for leukemia treatment

By Mass High Tech Staff

Genzyme Corp. has announced that it is seeking U.S. Food and Drug Administration approval for Clorar, its adult treatment for acute myeloid leukemia, by filing a supplemental New Drug Application form.

Clolar is already used in the U.S. and Europe to treat acute lymphoblastic leukemia (ALL) in patients under 21 years old with a record of two or more prior treatments, the company said.
AML, a common condition for acute leukemia-afflicted adults, is marked by normal blood cell production interrupted by abnormal blood cells in the bone marrow. The disease has a median age of patients of 35 years old, with about 13,290 people receiving the diagnosis in 2008, according to the American Cancer Society.

The new drug, if approved, would allow Genzyme to treat adults over 60 years old who tend to have “poor outcomes.” In Phase 2 clinical trials, Clolar was linked to a 45 percent overall remission rate. Now, Clolar is being tested in Phase 3 clinical trials to treat adult AML as either a single agent or in combination with other treatments. The drug currrently has Orphan Drug status to use Clolar for adult and pediatric ALL.

Genzyme jointly developed Clolar -- marketed in Europe as clofarabine -- with the New York-based biotechnology firm, Bioenvision Inc., which it bought in October 2007.

Founded in 1981, Genzyme (Nasdaq: GENZ) 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.