Actelion's selective S1P1 receptor agonist moves into advanced clinical development in psoriasis

Roche to leave S1P1 alliance following comprehensive portfolio review and prioritization

09-Dec-2009 - Switzerland

Actelion Ltd announced that the company has decided to proceed with advanced clinical development with its orally available and selective S1P1 receptor agonist (ACT-128800) in psoriasis. ACT-128800 is already in advanced clinical development for multiple sclerosis, where a dose-finding study has started recruiting patients in early October 2009.

Actelion will move forward in developing ACT-128800 in these two programs and other autoimmune indications. Basel-based Roche informed Actelion that it does not wish to continue the S1P1 alliance, following a comprehensive portfolio review. Since the integration of the Genentech portfolio, Roche has been carrying out extensive reviews of its combined R&D portfolio.

The decision by Roche to leave the alliance results in accelerated recognition of the deferred revenues from milestones previously paid to Actelion. As of the date of termination, the amount of unrecognized revenue was USD 88.7 million, which will be recognized over the 6 months starting in December of this year.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "I would like to thank Roche for their contribution and their expertise in progressing this program to the present stage. Today, Actelion has all the assets at hand - medical know-how, global development, global sales and marketing capabilities and strong cash flow - to successfully develop and commercialize our promising selective S1P1 receptor agonist in several indications."

Actelion's decision to advance its selective S1P1 receptor agonist for the treatment of psoriasis is based on a recently concluded Phase IIa proof-of-concept study. While this short term study did not reach statistical significance, sufficient information was obtained to proceed with a first pivotal study in psoriasis.

The Phase IIa study also extended the safety information of ACT-128800, previously established in healthy volunteers, to a larger group of psoriasis patients for up to six weeks of treatment. Full study results will become available through future presentation at major scientific meetings and subsequent scientific publication.

https://www.bionity.com/en/news/110553/actelion-s-selective-s1p1-receptor-agonist-moves-into-advanced-clinical-development-in-psoriasis.html