BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN) today announced that Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets), the first FDA-approved orally disintegrating tablet form of prednisolone, is now commercially available in the United States. The Orapred product line, which includes Orapred ODT and Orapred(R) (prednisolone sodium phosphate oral solution) is marketed by Alliant Pharmaceuticals, Inc., pursuant to a North American license and acquisition agreement entered into on March 15, 2006.
Orapred is prescribed primarily for acute exacerbations of asthma in children, and is also used to control severe, persistent asthma and to reduce inflammation seen in numerous medical conditions including arthritis and cancer. Orapred ODT utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, non-refrigerated and convenient formulation of prednisolone.
"We are pleased that Orapred ODT is now commercially available in the United States and look forward to working along side Alliant in their effort to achieve a successful product launch," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin.
Under the terms of the agreement, BioMarin has received a $4 million milestone payment in association with product launch and will receive a final $4 million milestone payment on June 1, 2007, the one year anniversary of the approval of Orapred ODT. Additionally, BioMarin will receive royalties on Orapred products sales. BioMarin will retain commercial rights to the Orapred product line outside of North America.
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio is comprised of two 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, and Aldurazyme(R) (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation. Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU), and 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of poorly controlled hypertension. 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 sales and marketing expectations of Orapred; and the continued development and commercialization of Orapred, including Orapred ODT. 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: Alliant's success in the commercialization of Orapred; the market for each of these products and particularly Orapred ODT; actual sales of Orapred; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2005 Annual Report on Form 10-K, as amended, and the factors contained in BioMarin's reports on Form 10-Q and Form 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.
NOTE: Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Orapred(R) is a registered trademark of Medicis Pediatrics, Inc. and is used under license.
Contacts: Investors Media Joshua A. Grass Susan Ferris Senior Director, Business Senior Manager, Corporate Communications Development & Finance BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc. 415-506-6701 415-506-6777
SOURCE: BioMarin Pharmaceutical Inc.
CONTACT: investors, Joshua A. Grass, Senior Director, Business
Development & Finance, +1-415-506-6777, or media, Susan Ferris, Senior
Manager, Corporate Communications, +1-415-506-6701, both of BioMarin
Web site: http://www.bmrn.com/