Irvine, CA—ISTA Pharmaceuticals Inc. has licensed exclusive North American rights to nasal dosage forms of bepotastine, an investigational product for the treatment of allergy symptoms, from Tanabe Seiyaku Co. Ltd. ISTA said it expects to complete the formulation of nasal bepotastine next year and begin clinical development in late 2008 or early 2009.
Last year, ISTA obtained exclusive North American rights to ophthalmic allergy applications of bepotastine and has been developing an ocular formulation of bepotastine to treat the symptoms of ocular itching that accompany reactions to allergens.
“Based upon our interactions with our thought leaders, 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,” stated Vicente Anido Jr., president and chief executive officer of ISTA. “Further, the medical community has experience treating ocular allergy symptoms with a nasal formulation antihistamine.” The company intends to continue to specialize in ophthalmology-related products, he added.
Bepotastine has three primary mechanisms of action, according to the company:
• It is a non-sedating, selective antagonist of the histamine 1 receptor.
• It has a stabilizing effect on mast cells.
• It suppresses the migration of eosinophils into inflamed tissues.
Under the terms of the license agreement, ISTA will make an upfront payment of $2 million to Tanabe, additional payments based on the achievement of development and approval milestones, and royalties on future product sales. ISTA is responsible for all costs associated with developing the drug 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.
Bepotastine was approved in Japan for use in the treatment of allergic rhinitis in 2000 and urticaria/pruritus in 2002. The drug is marketed there by Tanabe under a brand name (Talion). The drug was co-developed by Tanabe and Ube Industries Ltd., which discovered bepotastine. In 2001, Tanabe granted Senju Pharmaceutical Co. Ltd. exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture, and market bepotastine for ophthalmic use. ISTA licensed the North American rights to ophthalmic allergy applications of bepotastine from Senju in 2006.