This change of partner in North America follows the decision made by Endo Pharmaceuticals Holdings following its own internal strategy changes to return all rights for Rapinyl (Abstral) to Orexo. Endo has invested approximately $40 million in the development of Rapinyl, and Orexo has received an additional $26.9 million in licensing payments. Endo will finalize and finance the current Phase III studies of Rapinyl expected to end in December 2008.
ProStrakan is currently Orexo’s exclusive partner for sales and marketing of Rapinyl in most of Europe. Rapinyl received a positive opinion in June 2008, recommending the product’s approval, from the committee for medicinal products for human use of the European Medicines Agency. The plan is to launch the product, branded as Abstral, in Sweden in the third quarter of 2008, with further EU launches taking place from the end of 2008.
Under the terms of the new agreement with Orexo covering North America, ProStrakan will commit to upfront and certain regulatory and sales milestone payments totaling $29 million, including a $2 million signing fee.
In connection with the new agreement, the approval milestones for the five biggest markets in Europe will change from E5 million to $5 million. Royalties for Europe have been increased by 7 to 9% units and the royalty rate for North America will be increased by the same percent units compared to the agreement with Endo.
Wilson Totten, CEO of Prostrakan, said: “This deal allows us to leverage our extensive knowledge of this product and potentially provides us with a further oncology support product to be marketed by our specialist US sales force.”