Date: Dec 05, 2013 Author: Don Seiffert Source: bizjournals (
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Don Seiffert
Burlington, Mass.-based biotech Dyax Corp. has received orphan drug designation — with the potential for faster approval and longer market exclusivity — for what it hopes will be a longer-lasting drug to treat the rare condition that causes painful swelling, hereditary angioedema (HAE).
Dyax is now developing its second drug to treat HAE, after getting approval for its first — now marketed as Kalbitor — in 2010. Jennifer Robinson, spokeswoman for the company, said that while Kalbitor is intended to be administered within a few hours of a flare-up of the disease, DX-2930 is intended as an injection to be administered just once or twice a month to prevent inflammation.
DX-2930 began an early-stage trial in 32 patients with the disease in August, and results are expected next spring.
Several drugs developed by companies, including Shire and ViroPharma Biologics, have been approved in the past four years to treat HAE. Robinson said that one other company, Durham, N.C-based Biocryst Pharmaceuticals, is in clinical trials with a longer-lasting drug to treat HAE.
Orphan drug designation is reserved for potential drugs to treat diseases afflicting less than 200,000 patients in the U.S. About 10,000 people in the United States have HAE.
As of 2 p.m., Dyax stock was trading at $8.34 a share, down nearly a percent for the day but up 131 percent for the year so far, and within a dollar of its all-time high of $9.27.
