ProStrakan Group plc, the international specialty pharmaceutical company, announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a marketing authorisation for Abstral (for breakthrough cancer pain). This earlier than expected authorisation will enable ProStrakan to complete UK pricing negotiations and launch planning by the end of 2008, allowing UK sales of Abstral to make a full contribution in 2009.
Abstral (formerly branded as Rapinyl) is a fast-dissolving tablet for sub-lingual (under the tongue) administration of fentanyl intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. ProStrakan has in-licensed the exclusive rights to this product in Europe and North America from the Swedish pharmaceutical company, Orexo AB.
The committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Abstral in June 2008. ProStrakan and Orexo successfully launched Abstral in Sweden, the reference state, in August 2008 through their Nordic Joint Venture and ProStrakan plans further EU country launches as additional national licences are granted.
Commenting on the approval, Dr Wilson Totten, chief executive of ProStrakan, said, "Abstral is an important product for cancer patients suffering from the debilitating effects of breakthrough pain and is expected to generate significant revenues for ProStrakan. 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.
"Its UK approval is a major achievement for ProStrakan and comes on the back of last week's significant announcement of the US approval of Sancuso, for the prevention of chemotherapy-induced nausea and vomiting, which we also plan to launch before the end of the year. As oncology support products, these medicines are particularly complementary and, alongside our existing successful European business, will further underpin our objective of achieving profitability by 2010."
ProStrakan ProStrakan Group plc is a specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets.