ISTA licenses eye drop treatment for allergic conjunctivitis from Senju Pharmaceutical

By Lisa Kerner

Charlotte, N.C., Aug. 2 - ISTA Pharmaceuticals, Inc. said it has licensed exclusive North American rights to an eye drop formulation of bepotastine, an investigational ophthalmic treatment for the treatment of allergic conjunctivitis, from Senju Pharmaceutical Co., Ltd.

Under the companies' agreement, ISTA will pay Senju an upfront payment and milestones of about $6 million, plus royalties on future product sales.

ISTA is responsible for all costs related to the product's development in ophthalmology for North America, including clinical trials, regulatory filings, manufacturing, marketing and sales.

Bepotastine, the third product candidate in-licensed by ISTA this year, marks the company's entrance into the area of allergy treatments.

ISTA plans to move bepotastine into phase 3 clinical studies in the United States in early 2007 and to file a New Drug Application with the Food and Drug Administration by early 2008.

Bepotastine has a stabilizing effect on mast cells and suppresses the migration of eosinophils into inflamed tissues.

"The ophthalmic allergy market is a tremendous new opportunity for ISTA, representing approximately $450 million in prescriptions in the United States last year," president and chief executive officer Vicente Anido Jr. said in a company news release.

"We believe that bepotastine's multiple mechanisms of action and its non-sedating properties make it an ideal late-stage product candidate for ISTA to enter this important segment of the market."

Bepotastine is approved in Japan for use in the treatment of allergic rhinitis and uriticaria/puritus.

ISTA is a specialty pharmaceutical company located in Irvine, Calif.

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