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