Ista CEO Eyes Bepreve Launch In 2009
This article was originally published in The Pink Sheet Daily
Executive Summary
CEO Vince Anido tells “The Pink Sheet” DAILY that the firm plans to file an NDA for the allergic conjunctivitis treatment in the second half of 2008.
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Ista Pharmaceuticals will file an NDA for its allergic conjunctivitis treatment Bepreve (bepotastine ophthalmic solution) in the second half of 2008 as a result of the initiation of a Phase III trial and FDA's acceptance of a Phase II trial that was powered as a Phase III, CEO Vince Anido told "The Pink Sheet" DAILY. The exec also said that the firm is anticipating approval by mid-2009. During a Nov. 1 earnings call, Anido told investors that the candidate had the potential to take market share away from two heavyweights in the space, Alcon's Pataday and Patanol (olapatadine ophthalmic solution). "Those two products combined are now generating revenues of well over $450 million in annual sales, and we believe that Bepreve could be a strong competitor to this franchise," he said. Anido told the DAILY that the Phase III trial will eventually enroll "several hundred" patients, and top-line results are expected in spring 2008. Irvine, Calif.-based Ista has high expectations for Bepreve in other indication as well. The firm also has its sights set on Bepreve for nasal allergies. In a deal announced in late September, Ista licensed the North American rights to bepotastine for the allergy indication from Japanese pharma Tanabe Seiyaku (1 (Also see "Ista Gains North American Rights To Bepotastine For Nasal Allergies From Tanabe Seiyaku" - Pink Sheet, 27 Sep, 2007.)). Ista VP-Corporate Development Lauren Silvernail said that due to the additional costs associated with initiating the Phase III Bepreve clinical trial, the firm is expecting a net loss larger in the fourth quarter than the third. Ista reported a third-quarter loss of $8.2 million, However, Ista achieved its highest quarterly net revenues in company history of $15.9 million, a 92 percent increase over the third quarter of 2006, driven by a 117 percent revenue gain in sales of Xibrom (bromfenac ophthalmic solution) for treatment of post-operative inflammation. - Jonathan M. Block ([email protected]) [Editor's note: An exclusive interview with Ista CEO Vince Anido will appear in an upcoming issue of "The Pink Sheet" DAILY.] |