ProStrakan Gets Complete Response From FDA For Rectogesic

The complete response letter identifies issues that would have to be addressed before re-submission, including the generation of additional clinical data. ProStrakan plans to meet with the FDA in the near future and discuss these requirements, and the potential timetable, in more detail.

Rectogesic (formerly known as Cellegesic in the US) is already approved in the EU and marketed by ProStrakan in all major European countries. Rectogesic has also been out-licensed by ProStrakan to commercial partners in 34 countries worldwide.

Wilson Totten, chief executive of ProStrakan, said: “Even though this product is approved and being successfully marketed in the EU, it was always possible that further data may be required for a US approval. With this in mind, and with our current oncology focus in the US, we had not committed to commercialising Rectogesic ourselves in the US, nor had we made any partnering commitments.

“Consequently, we had not projected any US revenues from Rectogesic in our internal budgets. However, the unmet medical need in the US for a prescription medicine for treating chronic anal fissure pain remains, and ProStrakan will evaluate viable future paths for Rectogesic in the US.

“ProStrakan’s strategy is built around a diversified portfolio of products across Europe, the US and through partnering, so our success is not dependent upon any single product. We remain firmly focused on growing the business profitably and revenue growth for the Group in the first three months of 2010 at constant currency has reached approximately 30%.

“With Abstral awaiting FDA approval and Fortesta scheduled for re-filing by Endo in mid 2010, we remain confident of further advances in our US strategy during 2010. We anticipate continued growth from Rectogesic in the EU and further out-licensing deals in non-core geographic areas.”