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BioMarin and Alliant Announce FDA Approval of Orapred ODT
NOVATO, C.A. -- June 2, 2006 -- BioMarin Pharmaceutical Inc. 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 Orapred(R) (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.
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.
SOURCE: BioMarin Pharmaceutical Inc.
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