ProStrakan faces Abstral production shortage and FDA hold-up of Sancuso, as CEO resigns

Galashiels, Scotland-based specialty drugmaker ProStrakan Group (LSE: PSK) has provided investors with an update on the previously announced manufacturing status of Sancuso, a transdermal patch that delivers granisetron, and the company's discussions with the US Food and Drug Administration on its review of Abstral (fentanyl), which has been delayed by a request from the agency for additional information (The Pharma Letters August 18 and June 3).

This double dose of bad news, along with the resignation of the drugmakers chief executive, caused a 32.5% nosedive to 53 pence in the company's stock, and Piper Jaffray analys Sam Fazeli commented that ProStrakan may have trouble meeting its debt obligations.

On 19 August 2010, ProStrakan informed investors that the Company noted that it had been advised by Aveva Drug Delivery Systems, the manufacturer of Sancuso, that following an FDA inspection of the facility at which the drug is manufactured, Aveva had elected to cease manufacturing of all products at this facility for eight to12 weeks in order to make changes to its internal quality assurance systems. Following additional discussions with Aveva, ProStrakan has assessed that the manufacturing interruption, coupled with existing demand for Sancuso in the USA, will result in insufficient stocks held by the company and its distributors to meet customer demand from early October 2010. Aveva has informed ProStrakan that it plans to deliver a new batch of Sancuso patches as soon as possible and ProStrakan expects to recommence distribution in the first quarter of 2011. The shortfall is expected to adversely impact ProStrakan's operating profit for the 12 months to 31 December 2010 by up to £5.0 million ($7.7 million)