ISTA expands pipeline in allergy treatments

Under the terms of the agreement, ISTA will pay an upfront payment of $2 million to Tanabe, additional payments based on achievement of development and approval milestones, and royalties on future product sales.

ISTA is responsible for all costs associated with developing nasal Bepotastine for North America, including clinical trials, FDA filings, manufacturing, and, if the product is approved, marketing and sales activities. ISTA also obtained the right to develop other nasal Bepotastine products, including a fixed combination with a steroid, and a future right to negotiate for a North American license to oral dosage forms of Bepotastine for allergy treatment.

Vicente Anido, president and CEO of ISTA said: “As allergies affect both the eyes and the nose, we acquired the North American rights to nasal dosage forms of Bepotastine to provide us the opportunity to offer both nasal and ocular formulations to patients. We determined that complementing our ophthalmic formulation with a nasal formulation of Bepotastine would potentially allow patients to experience relief from both ocular and nasal allergy symptoms.”

ISTA anticipates completing the formulation of nasal Bepotastine in 2008 and entering into clinical development in late 2008 or early 2009. Bepotastine has three primary mechanisms of action. It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor, it has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound’s primary mechanisms of action are believed to make it an effective treatment for the symptoms of ocular and nasal allergies, according to ISTA.