Thursday, July 24, 2008

Alkermes seeks FDA nod for bipolar disorder drug

By Mass High Tech Staff

Cambridge biotech firm Alkermes Inc. reports that its partner, Johnson & Johnson (J&J), has asked the U.S. Food and Drug Administration for approval of the two firms’ drug, Risperdal/Consta, as a treatment for bipolar disorder.

The drug is already approved as a long-acting treatment for schizophrenia, according to Alkermes (Nasdaq: ALKS). The new approval for bipolar disorder, a condition that causes extreme high and low moods in patients, would expand the market for the drug to the 5.7 million Americans who are affected by bipolar every year.

Risperdal was approved in the U.S. in 2003, and it is cleared for sales in 80 countries worldwide, said Alkermes, which manufactures the drug.
 
In April, New Jersey-based J&J (NYSE:JNJ) submitted an application with the FDA for approval of Risperdal as an adjunct therapy for bipolar patients who are taking other drugs. This latest application seeks approval of the drug as a stand-alone treatment. 

In June, Alkermes reported its start of a Phase 3 clinical trial of its Vivitrol long-term treatment for opioid dependence.
  
Alkermes, which employs 610 workers, reported 2008 net income of $167 million on revenue of $240.7 million.