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BioMarin genetic disease drug OK'd
California company says Naglazyme gets FDA marketing approval, to be launched in about a month.
June 1, 2005: 6:39 AM EDT

NOVATO, Calif. (Dow Jones) - BioMarin Pharmaceutical Inc. (BMRN) received marketing approval from the Food and Drug Administration for its Naglazyme drug candidate.

In a press release Wednesday, the biopharmaceutical company said Naglazyne was approved for the treatment of MPS VI, a life-threatening genetic disease caused by the deficiency of an enzyme.

Naglazyme has been granted orphan drug status in the U.S., which confers seven years of market exclusivity. BioMarin plans to launch Naglazyme in the U.S. in about 30 days.

Separately, BioMarin also said that it had settled its proxy contest with Orimed and affiliated funds for the election of directors at the biopharmaceutical company. The Orimed group, which has an 8.22% stake in BioMarin, previously said that it intended to nominate three directors to the company's board.

Under the terms of the agreement, the BioMarin slate of nominees for election at the 2005 annual meeting will consist of Jean-Jacques Bienaime, Franz L.Cristiani, Elaine J. Heron, Pierre Lapalme and Erich Sager, all of whom currently serve on the board. In addition, two Orimed candidates, Joseph Klein III and Alan J. Lewis, will be nominated for election at the 2005 annual meeting.

OrbiMed Advisors and its affiliated funds have agreed to vote their shares in favor of these nominees and to terminate their solicitation of proxies.

After the 2005 annual meeting, BioMarin said it will appoint an additional director who is "reasonably acceptable" to OrbiMed.

OrbiMed's nominee Richard B. Brewer has agreed to withdraw his candidacy.

BioMarin's annual meeting will be held on June 28 .

-By Anjali Cordeiro, Dow Jones Newswires; 201-938-5400; AskNewswires@ dowjones.com Dow Jones Newswires 06-01-05 0502ET Copyright (C) 2005 Dow Jones & Company, Inc. All Rights Reserved.  Top of page

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