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Valeant Pharmaceuticals International, Inc.

Drug Names(s): balsalazide disodium capsules, Colazide, Colazid, Premid, BalAsa, mesalazine, mesalamine, 5-ASA

Description: BioMedTracker has separate drug profiles for the tablet and capsule formulations of Colazal. Please also see Colazal tablets.

5-aminosalicyclic acid, the active component of Colazal, is unknown, but appears to be topical rather than systemic. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways and through the lipoxygenase pathways is increased in patients with chronic inflammatory bowel disease, and it is possible that 5-aminosalicyclic acid diminishes inflammation by blocking production of arachidonic acid metabolites in the colon. It is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Deal Structure: In 1992, the Company licensed balsalazide disodium from Biorex Laboratories Limited in exchange for participation in future milestone revenues, royalties and profits.

In 1993, the Company outlicensed balsalazide, which is manufactured by third parties under contract with the Company, to Astra AB (throughout the world excluding Japan, Taiwan, Korea, Italy, Spain, Portugal and Greece) and Menarini Pharmaceutical Industries s.r.l. (Italy, Spain, Portugal and Greece), in return for a combination of milestone payments, participation in research and development costs, and sales of product at an agreed formula price.

In 1999, Astra AB merged with Zeneca PLC, a British pharmaceutical company, to create AstraZeneca PLC. In December 1999, the Company and AstraZeneca signed an agreement under which the marketing and distribution rights for balsalazide disodium previously licensed by the Company to Astra would return to the Company. AstraZeneca returned all rights, intellectual property...See full deal structure in Biomedtracker

Partners: Shire Pharmaceuticals Group PLC The Menarini Group

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