Wednesday, September 24, 2008

Dyax moves HAE treatment toward FDA approval

By Mass High Tech Staff

Biotherapeutics company Dyax Corp. has completed its biologics license application to get U.S. Food and Drug Administration approval for the company’s treatment for hereditary angiodema (HAE), an inflammatory condition that causes swelling. The drug treatment, DX-88 (ecallantide) is a recombinant small protein that had previously been given orphan drug status and fast track status by the FDA.

In its biologic license application, Dyax (Nasdaq: DYAX) requested priority review, given to companies and treatments addressing unmet medical issues, in order to speed the process toward commercialization, setting an FDA decision date six months out from the application receipt date.

Results from two Phase 3 clinical studies, Dyax officials reported, led to DX-88 showing improvements compared to placebo tests at two different study points. Caused by low plasma kallikrein inhibitor levels, HAE has swelling symptoms that may affect the extremities, gastrointestinal tract and larynx.

Dyax announced in August that it had named George Migausky as executive vice president and chief financial officer, who will be replacing Steve S. Galliker, who is retiring. Also last month, the company said it had secured a $50 million loan with equity firm Cowen Healthcare Royalty Partners LP. Some of the funds will be used to buy back its interest from a previous royalty agreement made in August 2006 with Paul Royalty Fund II LP.

Dyax reported a 2007 net loss of $56.3 million on revenue of $26.1 million. It employs a total of 177 workers.