Scotland-based specialty pharmaceuticals group ProStrakan says that talks with US regulators concerning Sancuso, its transdermal patch for the prevention of chemotherapy-induced nausea and vomiting have proved highly fruitful and a planned launch in the second half of the year is very much on track.

The company noted that as a result of continuing discussions with the US Food & Drug Administration, it believes that there are “now no outstanding technical questions” from the agency's review of Sancuso (granisetron) other than those which will be dealt with in labelling negotiations. ProStrakan submitted a New Drug Application for Sancuso in June 2007 and the FDA originally assigned an action date of May 2 this year.

However, due to “internal resource constraints at the FDA”, the date was amended to June 10 but it has become clear that “the remaining processes and procedural steps” cannot be completed by that date. As such, the current estimate is that these will be sorted out around July 7.

Wilson Totten, ProStrakan's chief executive, stated that the FDA review “is clearly now at a very advanced stage” and “we are increasingly confident of gaining US approval for Sancuso in the next few weeks”. He added that “we are now working with our manufacturers and suppliers to commit to manufacture of launch materials and maintain focus on our planned launch date, which remains scheduled for the second half of this year”.

The Galashiels-based firm recently signed up JapanBridge to commercialise Sancuso in several nations throughout South-East Asia and in return will receive more than $26 million in upfront and milestone payments.