CHICAGO, Dec 12 (Reuters) - Biotechnology company Myogen Inc. ( MYOG ) said on Monday its experimental drug for a rare vascular disease met the primary goal in a late-stage study, sending shares up 40 percent.
The news weighed heavily on shares of rival drugmakers Actelion (ATLN.S) of Switzerland and Houston-based Encysive Pharmaceuticals Inc.( ENCY )
The Myogen drug, ambrisentan, helped improve exercise capacity and delay worsening of pulmonary arterial hypertension, or PAH, a blood vessel disorder of the lungs in which pressure in the pulmonary artery rises above normal levels. Myogen, which is based in suburban Denver, said the drug also was generally well tolerated.
Myogen said ambrisentan had no apparent effect on the activity or dosage of warfarin-type anticoagulants commonly prescribed for patients with the condition.[This is a key advantage vs ENCY’s Thelin.]
Based on what he said were "extremely strong" results, CIBC World Markets analyst Bret Holley said he expects the drug ambrisentan to be approved in early 2007.
The news sent shares of Myogen up $7.90 to $27.14 on the Nasdaq, while shares of Actelion, maker of rival drug Tracleer, tumbled 19.2 percent in late trading on Monday in Switzerland.
Bill Freytag, Myogen's chief executive, said results from a second pivotal-stage trial of ambrisentan are expected in the second quarter of next year.
If that trial is also successful, "it wouldn't be unusual to be able to file with the FDA (U.S. Food and Drug Administration) within three or four months," the CEO said.
He said Myogen will seek a 6-month priority review by the FDA and will file at the same time for European regulatory approval of ambrisentan.
An Actelion spokeswoman said its flagship drug should continue to have a leadership role in treating PAH.
It was the second blow in as many weeks for Actelion, whose shares dived on Nov. 28 after a clinical trial found Tracleer failed to help patients with pulmonary fibrosis, a serious lung disease. "People have been too optimistic on Tracleer, in our view, and sentiment is against them," said Karl Keegan, a biotech analyst with Canaccord Capital in London.
Shares of Encysive Pharmaceuticals, which is seeking regulatory approval in Europe and the United States for its PAH treatment, called Thelin, also took a hit on Myogen's news, falling $3.20, or 28.62 percent, to $7.98 in Monday trade on Nasdaq.
Pfizer Inc. ( PFE ) in June received FDA approval to sell Revatio, a drug that uses the active ingredient in erectile dysfunction treatment Viagra, as a treatment for PAH, which affects about 200,000 people worldwide.
Revatio and ambrisentan work by two different mechanisms of action and may eventually be used together, much as heart failure patients are now treated with a combination of therapies, Freytag said.
"At some point in the future, we will do that study," he said.
Patients with pulmonary arterial hypertension experience extreme shortness of breath as the heart struggles to pump against high pressure in the lungs, causing such patients to ultimately die of heart failure.
Myogen is also developing a treatment for resistant hypertension, darusentan, for which it is now talking with regulators about the design of a pivotal-stage trial. <<
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