BioMarin Pharmaceutical Inc. Announces U.S. FDA Acceptance Of Orapred ODT Filing
NOVATO, Calif., Oct. 19 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets), a new formulation of Orapred(R) (prednisolone sodium phosphate oral solution). Prednisolone is commonly used to reduce inflammation seen in numerous medical conditions including asthma, arthritis and cancer. The FDA will take action on the application, under the Prescription Drug User Fee Act (PDUFA), by June 1, 2006.
Orapred ODT utilizes proprietary oral disintegrating tablet technology to provide a taste-masked, non-refrigerated and easy-to-administer formulation of prednisolone. There are currently no prednisolone oral disintegrating tablets on the U.S. market.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio is comprised of three approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme(TM) (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin, Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), and Orapred(R) (prednisolone sodium phosphate oral solution) for inflammatory conditions. Investigational product candidates include Phenoptin(TM) (sapropterin hydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). For additional information, please visit www.BMRN.com.
Information on BioMarin's website, www.BMRN.com, is not incorporated by reference into this press release.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development of Orapred ODT and BioMarin's other product candidates; the continued development and commercialization of the Orapred brand; filings with and actions by regulatory authorities; and BioMarin's Orapred operations. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: the content and timing of decisions by the FDA concerning Orapred ODT and Phenoptin; our success in the continued commercialization of Orapred; the market for Orapred and Orapred ODT; our ability to successfully develop our product candidates; the results of current and future clinical trials of Phenoptin; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Factors That May Affect Future Results" in BioMarin's 2004 Annual Report on Form 10-K and the factors contained in BioMarin's reports on Forms 10-Q and 8-K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts: Joshua A. Grass Susan Ferris BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. 415-506-6777 415-506-6701
BioMarin Pharmaceutical Inc.CONTACT: Joshua A. Grass, +1-415-506-6777, or Susan Ferris,+1-415-506-6701, both of BioMarin Pharmaceutical Inc.
Web site: http://www.bmrn.com/