FDA News Lifts Dyax Slightly - Analyst Blog

Shares of Dyax Corp. DYAX were up slightly to close the trading session on April 4 at $8.64 per share following the U.S. Food and Drug Administration's (FDA) decision to approve the company's subcutaneous treatment KALBITOR (ecallantide) for a wider patient population the day before.

KALBITOR, a plasma kallikrein inhibitor, was originally approved by the FDA in late 2009 for treating acute attacks of hereditary angioedema HAE in patients aged 16 years and above. Following the FDA's move, the drug can be used to treat acute HAE attacks in patients aged 12 years and above. Following the FDA approval, KALBITOR becomes the first and only subcutaneous therapy for treating acute HAE attacks in patients aged 12 years and above. Dyax also stated in its press release that the drug is the sole approved therapy that is not purified from human plasma for treating this patient population.

The U.S. regulatory body's decision to expand the target population of KALBITOR, Dyax's sole marketed product, was based on encouraging data from 2 phase III trials EDEMA3 and EDEMA4 (which were completed previously) in addition to data from the DX-88/19 study. We note that the DX-88/19 study was underway when the drug was originally approved in Dec 2009.

KALBITOR recorded net sales of $40.5 million in 2013. The company expects net sales in the range of $44 million–$49 million from the product in 2014. Following the FDA approval of the drug for a wider HAE population, we believe that the guidance will be achieved easily. Dyax is developing DX-2930 for the prevention of HAE attacks (phase Ia completed; phase Ib scheduled to start in mid-2014).

HAE, a rare genetic deficiency, is characterized by severe, debilitating and often painful swelling. The swelling can occur in the abdomen, face, hands, feet and airway.  According to data released by the U.S. Hereditary Angioedema Association, approximately 6,500 people are currently affected by this disease in the U.S. Apart from KALBITOR, the HAE market includes Shire's SHPG Cinryze and Firazyr.

Dyax carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare industry include Alexion Pharmaceuticals, Inc. ALXN and Gilead Sciences, Inc. GILD all carrying a Zacks Rank #1 (Strong Buy).