Healthcare Industry News: orally disintegrating tablet
News Release - March 15, 2006
BioMarin and Alliant Pharmaceuticals Announce North American Licensing Agreement for OrapredNOVATO, Calif, March 15 (HSMN NewsFeed) -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN News) and Alliant Pharmaceuticals, Inc., a privately held specialty pharmaceutical company located in Alpharetta, Georgia, announced today that they have entered into a licensing and acquisition agreement pertaining to exclusive North American rights to the OrapredŽ (prednisolone sodium phosphate oral solution) product line, including Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets).
Orapred ODT is expected to commercially launch in the United States during the second half of 2006. Under the terms of the agreement, BioMarin will receive payments and royalties based on the product's approval, launch and level of sales. BioMarin will retain commercial rights outside of North America.
"This partnership aligns well with both BioMarin and Alliant's business strategy," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "Orapred no longer fits well with our core business of developing and commercializing novel products for serious genetic and metabolic diseases. Alliant is a high quality specialty pharmaceutical company currently focused exclusively on the pediatric market. They have the capabilities and commercial infrastructure that positions them to quickly capitalize on the superior product profile of Orapred ODT."
"We strive to provide products that are innovative as well as improve the lives of our pediatric patients. Orapred is well aligned with our vision and is a strategically sound addition to our line of products," added Mark Pugh, Chief Executive Officer of Alliant Pharmaceuticals.
Orapred is the leading brand of liquid prednisolone sodium phosphate used to treat exacerbations of asthma and other inflammatory diseases and conditions in children. In 2003, approximately 2.4 million prescriptions of Orapred were written in the United States, representing greater than 50 percent market share, and net product sales of approximately $49 Million.
Orapred ODT, a new formulation of Orapred currently under review by the U.S. Food and Drug Administration (FDA), utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, non-refrigerated and easy-to-administer formulation of prednisolone. In August 2005, BioMarin filed a New Drug Application for Orapred ODT with the FDA. Pursuant to the Prescription Drug and Pharmaceutical Act, the FDA will take action on the application by June 1, 2006. If approved, Orapred would be the first orally disintegrating tablet corticosteroid dosage form available in the United States.
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). Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU) and 6R-BH4, a clinical-stage product candidate for the treatment of cardiovascular indications. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.
About Alliant Pharmaceuticals
Alliant Pharmaceuticals, Inc. is a Specialty Pharmaceutical company formed to develop and market a portfolio of innovative pharmaceutical products to pediatricians and pediatric specialty physicians. Alliant Pharmaceuticals focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs. Additional information about Alliant Pharmaceuticals in available online at: http://www.alliantpharma.com .
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: the sales expectations of Orapred; the continued development and commercialization of Orapred, including Orapred ODT; and actions by regulatory authorities, including actions related to 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 content and timing of decisions by the U.S. Food and Drug Administration concerning Orapred ODT; 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: 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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