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BURLINGTON, Mass., Dec. 27, 2012 (GLOBE NEWSWIRE) -- Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today the acquisition of manufacturing rights to its lead product TSO (
Trichuris suis ova or CNDO-201) from Ovamed GmbH, for North America, South America, and Japan, Coronado's licensed territory. As part of the transaction, Coronado entered into a lease agreement to establish a manufacturing facility in Woburn, MA to produce TSO.
Coronado entered into amendments to its existing license and supply agreements with Ovamed expanding Coronado's exclusive license to include TSO manufacturing rights in Coronado's territory and terminating Ovamed's exclusive supply rights once Coronado's planned manufacturing facility is operational. Build out and site preparation of the manufacturing facility are planned to commence in early 2013 and continue throughout the year to enable production of phase 3 supplies of TSO. Ovamed agreed to provide assistance in establishing the manufacturing facility and to continue to supply Coronado with clinical supplies until the facility is operational. Ovamed retains TSO manufacturing rights outside Coronado's territory, and the amendments contemplate that Coronado and Ovamed would act as second source suppliers to each other at agreed transfer prices.
Under the amendments, Coronado will pay Ovamed a total of $1.5M in three equal installments in 2014-2016, and, in lieu of product supply payments that would have been payable to Ovamed as the exclusive supplier, certain fees for product manufactured and sold by Coronado.
"The acquisition of exclusive manufacturing rights for TSO in our territories is an integral piece of our strategy for our lead product in development, and enables us to control the development and commercialization of the product," said Dr. Bobby W. Sandage, Jr., President and CEO of Coronado. "The amended agreement is not only cost effective, but also reduces product risk by having two qualified suppliers of TSO. We continue to move forward with our TRUST-I trial, the company's phase 2 Crohn's study, as well as our support for the recently initiated and planned investigator-initiated clinical trials evaluating TSO in a broad range of autoimmune diseases."