Lev Pharmaceuticals Inc., the company developing Cinryze to treat a rare genetic disorder, fell the most in 20 months in over-the-counter trading after U.S. regulators delayed approval of the drug.
Lev dropped 54 cents, or 33 percent, to $1.09 at 3:59 p.m. New York time, its biggest loss (LEVP:US) since May 31, 2006.
The Food and Drug Administration asked for more data on how well the drug works and information about its chemistry, manufacturing and controls, Lev said in a statement yesterday. Cinryze is being considered to treat and prevent attacks of hereditary angioedema, or HAE, a disorder that causes debilitating swelling of the face, airways or intestinal tract in about 10,000 Americans.
``All along, we have projected the timing for approval to be in the latter part of the year because few small companies pass through the FDA process in one shot,'' said Alex To, an analyst at Natixis Bleichroeder in New York, in a note to clients today. ``We do not think this delay will pose a significant threat to the company's prospect of being the dominant player in the HAE market.''
To recommends buying shares on the stock's weakness today and doesn't own any. He expects sales of the drug to reach $144 million by 2010.
Lev, based in New York, said in its statement that the FDA hasn't asked for any new studies. The company will answer the agency's concerns ``in a timely manner'' and hopes to win approval by the middle of this year, it said.
Race to Market
No drugs have been approved in the U.S. for attacks of hereditary angioedema, and Lev has been in a race with companies including Jerini AG and Pharming Group NV (PHARM) to be the first with a product on the market. Cinryze was granted priority review under an FDA program to speed approval of products that offer significant improvement over existing therapies.
The drug is Lev's leading product candidate and is also being developed as a treatment for heart attacks.
Hereditary angioedema is caused by a genetic defect that affects a protein called C1 inhibitor. The protein is normally responsible for regulating inflammation in the body, and malfunctions can lead to rapid swelling or even death if airways become blocked. Cinryze, given intravenously, replaces the deficient protein.
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