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"As allergies affect both the eyes and the nose, we acquired the NorthAmerican rights to nasal dosage forms of bepotastine to provide us theopportunity to offer both nasal and ocular formulations to patients. As manyof you know, we have close relationships with the ophthalmic community, and,based upon our interactions with our thought leaders, we determined thatcomplementing our ophthalmic formulation with a nasal formulation ofbepotastine would potentially allow patients to experience relief from bothocular and nasal allergy symptoms," stated Vicente Anido, Jr., President andCEO of ISTA. "Further, the medical community has experience treating ocularallergy symptoms with a nasal formulation antihistamine.
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"As we now have four product candidates in our pipeline, T-Pred(TM),ecabet sodium, ophthalmic bepotastine and nasal bepotastine, that will be ofinterest to a broader audience, we will look to maximize the value of ourassets beyond the non-ophthalmic community by exploring options to work withothers to expand our sales reach. However, it is our intention that ISTA willremain committed to the ophthalmologist and retain our ophthalmic specialistfocus."
ISTA anticipates completing the formulation of nasal bepotastine in 2008and entering into clinical development in late 2008 or early 2009. Bepotastinehas three primary mechanisms of action. It is a non-sedating, selectiveantagonist of the histamine 1 (H1) receptor, it has a stabilizing effect onmast cells, and it suppresses the migration of eosinophils into inflamedtissues. The compound's primary mechanisms of action are believed to make itan effective treatment for the symptoms of ocular and nasal allergies.
Under the terms of ISTA's license agreement with Tanabe, ISTA will pay anupfront payment to Tanabe of $2 million, additional payments based onachievement of development and approval milestones, and royalties on futureproduct sales. ISTA is responsible for all costs associated with developingnasal bepotastine for North America, including clinical trials, FDA filings,manufacturing, and, if the product is approved, marketing and salesactivities. ISTA also obtained the right to develop other nasal bepotastineproducts, including a fixed combination with a steroid, and a future right tonegotiate for a North American license to oral dosage forms of bepotastine forallergy treatment.
Conference Call
ISTA will host a conference call with a simultaneous webcast on September26 at 5 PM Eastern Time to discuss today's announcement regarding ISTA'slicense of exclusive North American rights to nasal dosage forms ofbepotastine. To access the live conference call, U.S. and Canadianparticipants may dial (800) 599-9795; international participants may dial(617) 786-2905. The access code for the live call is 89370716. To access the24-hour audio replay, U.S. and Canadian participants may dial (888) 286-8010;international participants may dial (617) 801-6888. The access code for thereplay is 21178468. This conference call will also be webcast live andarchived on ISTA's website for 30 days at http://www.istavision.com.
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