Penwest Halts Beta Blocker Development Following "Not Approvable" Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm will halt development efforts for PW2101 due to FDA's concerns outlined in a "not approvable" letter and because of the limited commercial window for the product.
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Penwest has halted efforts to develop the beta blocker PW2101 following an "not approvable" letter from FDA, the company said June 29. The company filed the NDA on Aug. 30 under the 505(b)(2) approval pathway, setting a user fee deadline of June 30. The compound used Penwest's TIMERx oral controlled-release delivery system. The company sought approval for use in treating hypertension and angina. FDA issued the not approvable letter due to "the degree of kinetic variability of PW2101 observed among individuals and because beta blockade as a surrogate for efficacy was not demonstrated across the entire inter-dosing interval on an individual subject basis," Penwest said. In deciding to halt the development program, Penwest cited "FDA's concerns, the time and resources the company expects it would take to address them, and the commercial window for this product opportunity." In December, Penwest announced the results of its 110-patient pivotal efficacy trial for a low-dose strength of PW2101. Although the randomized trial did not reach statistical significance on the primary endpoint of a change in Mean Seated Office Cuff Diastolic Blood Pressure from baseline to week six, Penwest said that "the study did reach statistical significance for some of the key secondary endpoints." The NDA included three higher strengths of the beta blocker. In April, Penwest signed a licensing agreement with Prism Pharmaceuticals, giving Prism exclusive U.S. and Canadian marketing rights to PW2101. The deal included a non-refundable $4 mil. initial payment to Penwest. - Kathleen Michael |