Scotland-based speciality pharma ProStrakan Group has been boosted by an earlier-than-expected in the UK for the cancer drug Abstral a week after US regulators backed Sancuso, a patch for the prevention of chemotherapy-induced nausea and vomiting.
The Galashiels-based firm has announced that the Medicines and Healthcare products Regulatory Agency has issued a marketing authorisation for Abstral, a fast-dissolving formulation of fentanyl for breakthrough cancer pain. This means that ProStrakan can complete UK pricing negotiations and launch planning by the end of 2008.
Abstral, formerly branded as Rapinyl, is licensed from the Swedish pharmaceutical company, Orexo. The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the drug in June and ProStrakan and Orexo launched Abstral in Sweden, the reference state, in August through their Nordic joint venture.
Wilson Totten, chief executive of ProStrakan, said Abstral is expected “to generate significant revenues”. Its early UK approval “means that we can bring Abstral to our home market even sooner than had been planned and we expect it to make a material contribution in 2009”.
The UK approval for Abstral comes on the back of last week’s announcement of US approval from the Food and Drug Administration for Sancuso (granisetron). The latter will be launched before the end of the year and Sancuso will be marketed by 67-strong sales force, currently being established by ProStrakan in collaboration with Quintiles unit NovaQuest.
Dr Wilson added that as oncology support products, Abstral and Sancuso “are particularly complementary and, alongside our existing successful European business, will further underpin our objective of achieving profitability by 2010”.
