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.
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 US, representing greater than 50% market share, and net product sales of approximately $49 Million.
The deal also includes Orapred ODT, a new formulation of Orapred currently under review by the FDA, which utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, easy-to-administer formulation of prednisolone. Orapred ODT is expected to commercially launch in the United States during the second half of 2006. If approved, Orapred would be the first orally disintegrating tablet corticosteroid dosage form available in the US.
“This partnership aligns well with both BioMarin and Alliant’s business strategy,” stated Jean-Jacques Bienaime, CEO of BioMarin. “Orapred no longer fits well with our core business of developing and commercializing novel products for serious genetic and metabolic diseases.”