Biogen Inc. reported Monday it is discontinuing development ofHirulog, an anti-coagulant, following Phase III trial results thatrevealed the drug failed to achieve a statistically significant effect onangioplasty patients when compared with heparin.The company, which also released its third quarter financial results,said that included in its expenses for the quarter was a pre-tax chargeof $25 million related to dropping the Hirulog program, includingreserves for manufacturing the drug and ending the clinical trials.For the quarter ending Sept. 30, Cambridge, Mass.-based Biogenreported a net loss of $26.4 million, or 80 cents per share, comparedwith a net income of $11.3 million, or 33 cents a share for the sameperiod last year. Revenues for the third quarter of 1994 were $31.8million compared with $37.3 million a year ago.Kathryn Bloom, Biogen's director of communications, saiddiscontinuing Hirulog will not result in layoffs. Instead, she said,Biogen "expects to move back in the black" in the fourth quarter ofthis year.In a prepared statement, Jim Vincent, Biogen's chairman and CEOsaid, "While we are obviously disappointed in the Hirulog results,we are very positive about our beta interferon in the multiplesclerosis market."With the release earlier this year of successful Phase III trial resultsof beta interferon, Bloom said Biogen plans to file for marketapproval of the drug in the U.S. and Europe in the first half of 1995.Jay Silverman, of Wertheim Schroder & Co. Inc., in New York, saidif Hirulog were successful it would have been "icing on the cake" forBiogen. "Now you just have the cake, which is beta interferon," headded.The Phase III trials of Hirulog, Biogen said, failed to show statisticalsignificance when compared with heparin in reducing complicationsassociated with angioplasty, such as death, myocardial infarction,repeat angioplasty and emergency bypass surgery.Hirulog is a compound based on hirudin, which is a natural anti-coagulating enzyme secreted by leeches. It was being developed as areplacement therapy for heparin, which is marketed worldwide as ananti-coagulant.Bloom said Biogen isn't abandoning the drug altogether. Thecompany plans to look for a marketing partner to continuedevelopment, but no timetable has been set.Although statistical significance was not shown in the Hirulog trial,Biogen said "positive efficacy benefits were seen in selected patientpopulations."The double-blinded, placebo-controlled trial involved about 4,700patients at 113 hospitals in the U.S. and Europe. The findings will bereported Nov. 13 in Dallas at an American Heart Associationmeeting.Biogen released the Hirulog trial results after the market closed. Thestock (NASDAQ:BGEN) closed Monday at $49, up $1.75. n
-- Charles Craig
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