Healthcare Industry News: enzyme replacement therapy
News Release - January 10, 2006
BioMarin Establishes Commercial Operations in EuropeWilliam Aliski Appointed Vice President and General Manager, European Operations
NOVATO, Calif., and LONDON, Jan. 10 (HSMN NewsFeed) -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN News) announced today that it has established commercial operations in Europe in anticipation of receiving European marketing approval for Naglazyme(TM) (galsulfase), an enzyme replacement therapy for the treatment of mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome), in the first quarter of 2006. BioMarin Europe Ltd. is headquartered in London, with branch offices located in Spain, Switzerland and Italy.
William E. Aliski has been appointed Vice President and General Manager of European Operations, responsible for overseeing European commercialization efforts. Prior to joining BioMarin, Mr. Aliski served as Vice President of Commercial Operations at Transkaryotic Therapies, a biotechnology company that, prior to its acquisition by Shire Pharmaceuticals Group in July 2005, focused on the development and commercialization of products to treat rare diseases. In this role, Mr. Aliski managed worldwide drug distribution, inventory management and patient support for the company's lead product, Replagal, an enzyme replacement therapy for Fabry disease. Earlier in his career, Mr. Aliski worked at Genzyme Corporation, a biopharmaceutical company focused on serious diseases, including genetic disorders, where he served as Vice President of Health Systems and Vice President of Patient and Product Services, responsible for overseeing the development and implementation of reimbursement planning and launch for multiple products, including Cerezyme and Ceredase.
"We are pleased that Mr. Aliski has joined the BioMarin team and believe that his experience in the global commercialization of products for rare diseases further positions us for a successful European commercial launch of Naglazyme for MPS VI, pending final regulatory approval," stated Steve Aselage, Senior Vice President of Global Commercial Operations of BioMarin. "With BioMarin Europe now in place, we look forward to commencing our first European product launch and to making Naglazyme available to the European MPS VI community in the not too distant future."
BioMarin Europe, an Irish subsidiary, will be responsible for overseeing the sales and distribution of Naglazyme to the 25 member states of the European Union, Iceland and Norway. Those wishing to correspond with BioMarin Europe should contact:
BioMarin Europe Ltd.
23-24 Warwick Street
BioMarin, headquartered in Novato, California, 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, AldurazymeŽ (laronidase) for mucopolysaccharidosis I (MPS I), and OrapredŽ (prednisolone sodium phosphate oral solution) for inflammatory conditions. Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU). For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the development and commercialization of Naglazyme, particularly in Europe, and Phenoptin; and actions by regulatory authorities, particularly actions by the EMEA related to Naglazyme. 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: possible delays in launching Naglazyme in the E.U. and slow market penetration in the E.U.; the content and timing of decisions by the FDA and the EMEA and other regulatory authorities concerning Naglazyme and Phenoptin; 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. AldurazymeŽ is a registered trademark of BioMarin/Genzyme LLC.
OrapredŽ is a registered trademark of Medicis Pediatrics, Inc. and is used under license.
Source: BioMarin Pharmaceutical
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