Encysive Holds Hope For Thelin Despite Receiving Second “Approvable” Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Company says it does not anticipate having to collect additional data on the pulmonary arterial hypertension drug.
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Encysive will meet with FDA in the next 30 days to discuss a second "approvable" letter for its pulmonary arterial hypertension treatment Thelin (sitaxsentan), CEO Bruce Given said during a July 25 conference call. The company received a second "approvable" letter for Thelin July 24 after submitting an existing data set to FDA in May in response to an initial March approvable letter (1 (Also see "Encysive Avoids Additional Trials For Thelin NDA" - Pink Sheet, 25 May, 2006.)). Of the substantive items raised by FDA in the March 24 letter, one item remains unresolved, Encysive said. The company declines to disclose the nature of the item. "I feel that the agency clearly left the door open for further discourse on this point," Given said. "I feel like we're just at the top of the hill, and we need to get over the hill. We need to get over that hump to get approval." Given predicted that the FDA action will not impact a potential European launch. Encysive plans to begin selling Thelin (sitaxsentan) in Europe this fall once it is approved. On June 2, the European Medicine Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for the treatment; a final EU decision is pending (2 (Also see "Thelin Gets EMEA Committee Approval Recommendation" - Pink Sheet, 3 Jun, 2006.)). "I don't see how this has any impact at all on Europe, frankly," Given said. "I think that we're now at the phase where the regulatory authorities...have completed their work and we're at the European Commission stage of ratifying the work of the EMEA." In FDA's second letter, the agency again suggested additional clinical trial work. However, Given said: "Our goal is to not do a clinical trial, and frankly, we don't think that's the right outcome here. From our perspective, that would be a substantial delay." Given said the company will continue to support a sales force of more than 50 reps for Thelin. One encouraging point raised in the letter was FDA's "thorough" feedback on the company's risk management plan for the drug. Actelion's Tracleer (bosentan), an endothelin receptor agonist approved for PAH, has a risk management program requiring patients to receive liver function tests. Shares of Encysive closed July 25 down 40 to $3.69. -Jonathan Block |