Orexo received marketing authorization from the regulatory authorities of France and Spain for Abstral, its treatment for breakthrough cancer pain. The two additional approvals bring the total number of authorized European markets to five and trigger milestone payments of €1.3 million, or about $1.6 million, from ProStrakan. The drug is expected to launch in these two countries during the second half.
In June 2008, Abstral received a positive recommendation for approval in Europe by the EMEA and is currently distributed in Sweden, the U.K., and Germany by ProStrakan, the company's licensing and distribution partner in Europe and North America. The company expects more approvals to follow in the near future.
"The royalty stream that this product will generate will bring us closer to our goal of becoming a sustainable, profitable pharmaceutical company," says Torbjörn Bjerke, president and CEO of Orexo. "ProStrakan is doing an excellent job of rolling out Abstral to the major European markets, and together we are anticipating to be in a position to file for USA approval for the product in 2009."
Recently Orexo signed a licensing and distribution agreement for the drug with NovaMed and Neopharm for the Chinese and Israeli markets, respectively. The company has other partnerships for Abstral in Eastern Europe and the Commonwealth of Independent States with Gedeon Richter, in Japan with Kyowa Hakkoo Kirin, and in Southeast Asian territories with Hospira.
Abstral is a sublingual medication that administers fentayl, an opiod used to treat cancer pain, to patients who are already receiving opoid analgesics.