Ista acquires license to investigational ocular allergy treatment

IRVINE, Calif. — Ista Pharmaceuticals Inc. has licensed the exclusive North American rights to an ophthalmic formulation of bepotastine from Senju Pharmaceutical Co. Ltd., the company announced.

Bepotastine is currently being investigated as a treatment for allergic conjunctivitis. The compound is a non-sedating, selective antagonist of the histamine 1 receptor, which has a stabilizing effect on mast cells and suppresses migration of eosinophils into inflamed tissues, according to a press release.

The license agreement represents the company’s entrance into the allergy treatment area. It is the third product candidate licensed to Ista this year, according to the company.

Under the terms of the agreement, Ista will make an upfront payment to Senju and make aggregate development and approval milestone payments of approximately $6 million in addition to royalties on future sales. Ista is also responsible for all costs associated with developing bepotastine for ophthalmic indications in North America, including clinical trials, U.S. Food and Drug Administration filings, manufacturing and, if approved, marketing and sales activities.

Ista expects to begin phase 3 U.S. clinical studies in early 2007, based upon preclinical research and early-stage clinical evaluations done in Japan by Senju. Assuming timely completion and success of the trials, the company anticipates filing a New Drug Application with the FDA in late 2007 or early 2008, according to the release.

Bepotastine was codeveloped by Tanabe Seiyaku Co. Ltd. and Ube Industries Ltd. Tanabe Seiyaku granted Senju exclusive worldwide rights to develop and market the drug for ophthalmic use in 2001, with the exception of certain Asian countries. The drug is currently approved in Japan for treating allergic rhinitis and uriticaria/puritus, and remains marketed by Tanabe Seiyaku under the brand name Talion, according to the release.