Galashiels, Scotland, 28 September, 2007 – ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, today provides the market with an update on the progress of a number of products undergoing EU approvals processes following yesterday’s EMEA meetings:
· Rapinyl EU approval process enters extended phase · Droperidol receives EU approval
Rapinyl – breakthrough cancer pain. This patient-friendly formulation of fentanyl, a long-established opioid used for the management of episodes of severe breakthrough pain experienced by cancer patients who are already receiving opioid analgesics, entered the EU Decentralised Procedure (DCP) last year. Of the 25 member states involved in the DCP for Rapinyl, 21 consider this product to be approvable. Because consensus among all 25 member states has been required in the process so far, the product will now be referred for review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), where a majority decision is sufficient to gain approval. The exact timings of the CHMP process are not yet clear, but the Company believes that the approval process will extend into 2008. First launches are now likely to commence from the end of 2008.
Droperidol (Xomolix) – post-operative nausea and vomiting. This branded, injectable drug, used primarily in hospitals for the prevention and treatment of post-operative nausea and vomiting, has now successfully completed the European Decentralised Procedure (DCP). Droperidol is already marketed in eight European countries, including France, The Netherlands and Portugal. Today’s news means ProStrakan can market Droperidol (branded as Xomolix) across other EU markets, including Germany, Italy and Spain, once national licences have been issued. We intend to commence EU launches in 2008.
Further enquiries:
ProStrakan Dr Wilson Totten, Chief Executive Callum Spreng, Corporate Comms Director Tel: +44 (0) 1896 664100
Financial Dynamics David Yates/Ben Brewerton Tel: +44 (0) 20 7831 3113
