Forest Laboratories and PAION sign development agreement for Desmoteplase
US-based Forest Laboratories and German company PAION have entered into an agreement for the development and marketing of PAION\'s product, desmoteplase, in the US and Canada.
US-based Forest Laboratories and German company PAION have entered into an agreement for the development and marketing of PAION's product, desmoteplase, in the US and Canada.
Desmoteplase, a novel plasminogen activator, or blood clot-dissolving agent, is currently under development in the US and Europe for treatment of acute ischemic stroke.
First in a new class of plasminogen activators, it is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. It possesses high fibrin selectivity, allowing it to dissolve a clot locally without affecting the blood coagulation system, which is thought to potentially reduce the risk of intracranial bleeding as compared to less fibrin-specific plasminogen activators.
Positive results from a Phase II study showed that the compound has the potential to treat patients up to nine hours after the onset of stroke symptoms. The only currently available clot-dissolving agent must be administered within three hours of symptom onset; however, the majority of stroke patients arrive at the hospital outside that treatment window. At present, only 11% of ischemic stroke patients are eligible for the treatment and fewer than 4% actually receive it. Desmoteplase, with a longer treatment window, could expand the number of patients who receive clot-dissolving therapy.
Under the agreement, in addition to an initial sum PAION will receive milestone payments and a royalty based on sales, and Forest will fund all continuing clinical development activities for the US and Canadian markets. Forest will be responsible for regulatory and sales and marketing activities in the US and Canada and will have development and marketing rights to other indications of the product in these territories. PAION retains commercial rights in Europe, Japan and the rest of the world.
PAION and Forest will be finalising discussions with the US FDA regarding study protocols to serve as the basis for a new Biologics License Application (BLA) filing. A Phase IIb study is likely to be initiated in the third quarter of this year. Desmoteplase was re-cently granted fast track status by the FDA If the trials are successful, it is possible that a BLA for desmote-plase would be submitted to the FDA as early as 2007.
