Actelion/Roche S1P1 alliance achieves clinical milestone
Dose-finding Phase IIb study started in patients with multiple sclerosis
Actelion Ltd announced that the selective S1P1 receptor agonist ACT-128800/ RG3477 has achieved an important clinical milestone. Actelion's first-in-class selective S1P1 (Sphingosine-1-phosphate) receptor agonist has entered into a Phase IIb dose-finding study in patients suffering from multiple sclerosis. This triggers a milestone payment by Roche to Actelion of USD 20 million.
Actelion and Roche entered into an exclusive worldwide collaboration in July 2006 to jointly develop and commercialize Actelion's selective S1P1 receptor agonist, an immunomodulator with the potential for once-a-day oral dosing. The two companies plan to jointly develop and commercialize this novel compound for multiple autoimmune disorders. For the current selective S1P1 receptor agonist, Actelion will fully fund all development activities up to the end of Phase II for the first two indications. All subsequent development and commercialization costs will be shared equally between Roche and Actelion. Both companies will co-promote any product resulting from this collaboration and will equally share profit.
This S1P1 collaboration covers both the current selective S1P1 receptor agonist in clinical development, as well as any other selective S1P1 receptor agonists resulting from Actelion's research efforts in the field. Actelion received an upfront payment of USD 75 million in July 2006. In the case of future development and approval milestones being achieved, Actelion will be eligible to receive further payments of up to USD 535 million for the first compound for all targeted indications. Further development and approval milestone payments are due for additional compounds. Roche will pay Actelion undisclosed royalties on all product sales.
Sphingosine-1-phosphate (S1P) is a phospholipid released by platelets, mast cells and other cells. It is currently established that S1P stimulates at least five different G-protein coupled receptors (GPCRs): S1P1,2,3,4, and 5. Activation of these GPCRs mediates a complex variety of biological responses, such as lymphocyte migration, endothelial cell proliferation, blood vessel constriction and heart rate modulation.
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