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North American Licensing Agreement for Orapred Product Line
In March 2006, BioMarin and Alliant Pharmaceuticals, a privately held specialty pharmaceutical company located in Alpharetta, Georgia, entered into a licensing and acquisition agreement relating to the Orapred® (prednisolone sodium phosphate oral solution) product line.
Pursuant to the terms of the agreement, Alliant will receive exclusive North American rights to the Orapred product line, including Orapred ODT™ (prednisolone sodium phosphate orally disintegrating tablets), and BioMarin will retain rights in all other regions. In exchange, Alliant will pay BioMarin a $2.5 million upfront payment and $15.5 million in milestone payments, which are primarily contingent upon approval and launch of Orapred ODT in the United States. Additionally, Alliant will pay BioMarin royalties ranging from 25 percent to 30 percent on net sales of Orapred ODT, net of the royalties owed to CIMA LABs for use of their proprietary, taste-masking oral disintegrating tablet technology used in Orapred ODT. BioMarin will retain commercial rights outside of North America.
On June 1, 2006, BioMarin and Alliant announced
that the U.S. Food and Drug Administration granted
market approval of Orapred ODT, making it the first
orally disintegrating tablet form of prednisolone
available in the United States. Alliant launched
Orapred ODT in the United States in August 2006.
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