Guilford Pharmaceuticals Inc has licensed exclusive European development and commercialization rights for Dopascan Injection, its proprietary diagnostic imaging agent for Parkinson's disease, to MAP Medical Technologies of Finland.
Under the terms of the agreement, MAP and its affiliated companies will receive exclusive development, marketing, sales and distribution rights to Dopascan Injection for all European Union Member States and other select markets. Under the agreement, MAP will be responsible for seeking regulatory approvals, and for manufacturing, marketing and selling Dopascan Injection in these countries. In turn, Guilford will receive an initial upfront payment, milestone payments, and royalties on future product sales of Dopascan Injection within MAP's territories.
"Our agreement with MAP Medical Technologies represents a significant step in the international commercialization of Dopascan Injection," commented Craig R. Smith, President and Chief Executive Officer of Guilford. "MAP already has experience supplying Dopascan Injection for clinical investigative purposes in Finland and several other countries. We look forward to MAP's early filing for regulatory approval of Dopascan Injection in its home market, and subsequently in other EU markets."
"Dopascan Injection is an important addition to our product portfolio that now includes over two dozen radiopharmaceutical and radiochemical agents, which we manufacture and market throughout the European Union," commented Jukka Hiltunen, President and Chief Executive Officer of MAP. "Our intention is to move expeditiously to apply for regulatory approval of Dopascan Injection in Finland, and use any Finnish approval as the basis for applying for regulatory approval in other European countries."
Dopascan Injection is a novel diagnostic test for Parkinson's disease. The underlying technology was originally invented by Research Triangle Institute in Research Triangle Park, North Carolina, and licensed to Guilford Pharmaceuticals to develop. The product is a radiopharmaceutical, administered by injection, which allows physicians to image and quantitatively measure the density of dopamine nerve terminals in the brain, which deteriorate with disease progression in Parkinson's disease. By directly measuring this deterioration, Dopascan Injection may allow a more accurate diagnosis to be made earlier in the course of the disease, when diagnosis can be most difficult, as well as monitoring of disease progression, and possibly the effect of any disease therapy. Dopascan Injection has completed Phase II clinical trials in the United States and is in Phase III clinical trials in Japan, and has to date been administered to over 1,600 patients worldwide.
Parkinson's disease is a serious, debilitating neurodegenerative disorder afflicting more than one million people in the U.S. and an estimated 1.3 million people in Europe. In the United States, there is currently no approved diagnostic test for Parkinson's disease; therefore, diagnoses must be made from clinical observation. Unfortunately, this can result in misdiagnosis, in which Parkinson's disease is often confused with other non- Parkinson's conditions.
In 1996, Guilford licensed Dopascan Injection to Daiichi Radioisotope Laboratories (DRL), one of the leading radiopharmaceutical companies in Japan. Under the agreement, DRL received exclusive marketing, sales, and distribution rights to Dopascan Injection for Japan, Korea, and Taiwan.