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Valeant Pharmaceuticals International, Inc.

Drug Names(s): topibromfenac ophthalmic solution, Yellox (EU)

Description: Xibrom is a member of the class of non-steroidal anti-inflammatory drugs (NSAIDS). These are aspirin-like drugs that are inhibitors of prostaglandins. These are a group of compounds that act in tissues where they are liberated to elicit various inflammatory activities. Prostaglandins are generated in most tissues by activation of the arachidonic acid pathway. Briefly, phospholipids in the cell membrane are the substrate for the enzyme phospholipase A to cause generation of arachidonic acid and, in turn, the enzymes cyclo-oxygenases and lipoxygenases act on arachidonic acid to produce a family of chemically distinct prostaglandins (cyclo-oxygenases), and leukotrienes (lipoxygenases).

Xibrom, like other NSAIDS, acts primarily to inhibit cyclo-oxygenases and prevents the formation of prostaglandins (there is evidence that bromfenac is more selective for COX-2 than COX-1). This subsequently decreases the inflammation in the site of action following drug penetration. Thus, Xibrom treatment of eyes with inflammation following cataract surgery may stop the formation of prostaglandin and halt the inflammatory response to surgical trauma.

Ista is also developing a once daily version of Xibrom called Bromday for the treatment of Ocular Inflamation and a lower concentration version of Xibrom called Remura for the treatment of Dry Eye.

Historical revenue for Xibrom/Bromday are recorded under Xibrom.

Deal Structure: ISTA and Senju
In May 2002, as part of ISTA's AcSentient asset acquisition, ISTA acquired marketing rights for Xibrom in the United States. Under the terms of the agreements with Senju, ISTA is responsible for completing development activities for bromfenac. All follow-up activities with the FDA will be handled by ISTA. ISTA is responsible for the manufacture, marketing, sales, and distribution of Xibrom in the US. ISTA is required to pay to Senju certain non-refundable milestone payments relating to the development process and regulatory approval of Xibrom.

CROMA and Senju
In November 2005, CROMA Pharma GmbH licensed European development rights to bromfenac from Senju Pharmaceutical.

Bausch & Lomb and CROMA
In September 2009, Bausch & Lomb announced that several of its pharmaceuticals subsidiaries have been granted rights from CROMA Pharma GmbH to co-promote and sell bromfenac ophthalmic solution in Europe when it becomes available to the market....See full deal structure in Biomedtracker

Partners: Senju Pharmaceutical Co., Ltd. CROMA Pharma GmbH

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