Abstral is expected to be launched during the second half of 2009 in France and Spain, following pricing and reimbursement negotiations with the relevant authorities, by ProStrakan, Orexo’s exclusive licensing partner for Abstral in Europe and North America.
The two new approvals mean that Abstral has been approved in five European markets including Sweden, the UK and Germany since March of 2008, with further approvals anticipated in 2009. The approvals in France and Spain trigger milestone payments of E1.3 million to Orexo.
Abstral has received a positive recommendation for approval in Europe by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2008. It is currently launched in reference country Sweden, the UK and Germany.
Torbjorn Bjerke, president and CEO of Orexo, said: “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 US approval for the product in 2009. We look forward to continuing our successful partnership with ProStrakan in Europe and North America in the near future.”