Healthcare Industry News: phenylketonuria
News Release - June 1, 2006
BioMarin and Alliant Announce FDA Approval of Orapred ODTNOVATO, Calif., June 1 (HSMN NewsFeed) -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN News) and Alliant Pharmaceuticals, Inc., a privately held pediatric specialty pharmaceutical company located in Alpharetta, Georgia, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets), the first orally disintegrating tablet form of prednisolone available in the United States. Alliant expects to begin marketing Orapred ODT in the United States in August or September of 2006.
The Orapred product line, which includes OrapredŽ (prednisolone sodium phosphate oral solution) and Orapred ODT, is prescribed primarily for acute exacerbations of asthma in children. The Orapred product line 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 the FDA has granted marketing approval of Orapred ODT, giving physicians a new way to administer prednisolone to children experiencing severe exacerbations of asthma and to individuals with other inflammatory conditions," stated Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "With Alliant as our partner, we are well positioned to maximize the value of the Orapred product line."
"We are excited about the approval of Orapred ODT. This product addition fits perfectly into Alliant's strategy and vision of providing high quality products to market that best serve our pediatric patients," commented Mark Pugh, Chief Executive Officer of Alliant Pharmaceuticals.
On March 15, 2006, BioMarin and Alliant entered into a North American licensing and acquisition agreement relating to the Orapred product line. Under the terms of the agreement, BioMarin will receive payments and royalties based on the product's launch and percent of sales. BioMarin will retain commercial rights outside of North America.
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.
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 AldurazymeŽ (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. 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 and marketing 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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.
Related News ItemsBioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
U.S. FDA Placed a Clinical Hold on BMN 307 Phearless Phase 1/2 Gene Therapy Study in Adults with PKU Based on Interim Pre-clinical Study Findings
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close