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news.United Research Laboratories/Mutual Pharmaceutical Company, a private generic and branded drug firm, and specialty pharmaceutical firm Collegium Pharmaceutical have entered into a product development agreement for an undisclosed product.
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Collegium’s business model is to develop differentiated, patent-protected or high barrier to entry products, complete ‘proof of concept’ studies and then out-license the products for commercialization by a strategic marketing partner.
Under the terms of this agreement, Collegium will be responsible for all aspects of formulation development, process development, analytical development, manufacturing of clinical batches and pilot bioavailability for the product.
After this point, Collegium will transfer the technology to URL/Mutual for pivotal bioavailability, commercial manufacturing and commercialization. URL/Mutual will also be responsible for all required regulatory filings.
The agreement calls for Collegium to be paid certain milestones associated with the development of the product in addition to royalties on net sales.
The companies expect that the product will be available for launch in late 2006 or early 2007.