ISTA gains license for conjunctivitis formulation

ISTA Pharmaceuticals acquired from Senju Pharmaceuticals an exclusive North American license to an eye-drop formulation containing bepotastine, an investigational ophthalmic treatment for allergic conjunctivitis. This is ISTA Pharmaceuticals' first license for the ophthalmic allergy field.

Bepotastine is a non-sedating, selective antagonist of the histamine 1 receptor, has a stabilizing effect on mast cells, and suppresses the migration of eosinophils into inflamed tissues. These mechanisms are believed to make the drug an effective treatment against allergic conjunctivitis.

Under the agreement, ISTA Pharmaceuticals will pay Senju Pharmaceuticals an upfront payment and aggregate development and approval milestones of about $6 million, in addition to royalties on future product sales. ISTA Pharmaceuticals is responsible for all costs associated with developing bepotastine in ophthalmology in North America, including clinical trials, FDA filings, manufacturing, and if the product is approved, marketing and sales activities.

"We are pleased with the ongoing success of our business development initiatives this year to expand ISTA's pipeline strategically in critical market segments, including glaucoma and the allergy market. The ophthalmic allergy market is a tremendous new opportunity for ISTA," said ISTA Pharmaceuticals President and CEO Vicente Anido Jr. "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."

ISTA Pharmaceuticals anticipates that phase III clinical trials for the drug will start in the United States early next year. This is dependent upon extensive preclinical research and early-stage clinical evaluations by Senju Pharmaceuticals. Assuming timely completion and success of the trials, ISTA hopes to file a New Drug Application with the FDA in late 2007 or early 2008.