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Dyax Gets FDA Approval For Genetic Disorder Drug - Stocks To Watch

12/2/2009 2:16:16 AM
(RTTNews)  Dyax Corp. (DYAX) said the FDA has approved its Kalbitor for treating acute attacks of rare genetic disorder hereditary angioedema or HAE in patients 16 years of age and older. Kalbitor is the first injectable treatment approved for the disorder in the U.S., Dyax noted.

HAE attacks, which occur on average more than 20 times annually, are unpredictable. An acute episode may occur in one or more anatomical sites, sometimes moving from one site to another. The disorder is estimated to affect 1:10,000 to 1:50,000 individuals.

As part of the approval, the company set up a program to inform users about the risk of anaphylatic shock and the importance of determining the difference between hypersensitivity to the drug and a hereditary angioedema attack.

The drug, which is Dyax' first product, is also being evaluated for the prevention of blood loss during a certain type of heart surgery by Cubist Pharmaceuticals, Dyax' partner.

For the most recent third quarter, the company cut its loss by more than half to $12.2 million or 17 cents per share, from year-ago $26.6 million or 43 cents per share. Although revenues declined to $4.5 million from $5.5 million last year, the company was able to narrow its loss by lowering research and development expenses drastically to $7.1 million from $16.5 million last year.

As of September 30, 2009, Dyax had cash, cash equivalents, and short-term investments of $41.1 million, excluding, restricted cash. Also, the company raised net proceeds of $20.5 million through an equity offering completed on October 5, 2009. Dyax believes that it has the cash and resources to support ongoing operations through 2010.

Recently, Sanofi-Aventis licensed an eye drug and a cancer drug from Dyax collaborators. Dyax already has a relationship with Sanofi-Aventis from February 2008, when the latter licensed a Dyax antibody called DX-2240, as well as the rights to technology that helps identify potential drug candidates. That deal is worth up to $500 million, including a $25 million payment to Dyax last year.

by RTT Staff Writer

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