Roche and Actelion announced that they have entered into an exclusive worldwide collaboration to jointly develop and commercialize Actelion's selective S1P1 receptor agonist, an immunomodulator with the potential for once-a-day oral dosing.
The compound is currently being developed in phase I. The two companies plan to jointly develop and commercialize this novel compound for multiple autoimmune disorders.
"We are very pleased to partner with Actelion in this area where there are still a number of high unmet medical needs and only few treatment options are available," said Roche chairman and CEO Franz B. Humer. "This collaboration is a further step to strengthen our emerging autoimmune disease franchise."
Jean-Paul Clozel, MD and chief executive officer of Actelion commented: "I am very proud about our collaboration with Roche, an excellent partner to develop and promote multiple indications in parallel. Together, we are well prepared to turn Actelion's scientific breakthrough in selective S1P1 receptor agonists into a treatment that has the potential to dramatically improve medical care for patients with autoimmune disorders."
The S1P1 collaboration covers both the current selective S1P1 receptor agonist in phase I as well as any other selective S1P1 receptor agonists resulting from Actelion's research efforts in the field. Roche will pay Actelion an upfront payment of USD 75 million in the second half of 2006. In the case of future development and approval milestones being achieved, Actelion will be eligible to receive payments of up to USD 555 million for the first compound for all targeted indications. Further development and approval milestone payments are due for further compounds. On all product sales, Roche will pay Actelion undisclosed royalties.
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 equally share profit.
Sphingosine-1-phospate (S1P) is a phospholipid released by platelets, mast 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, heart rate modulation and others.
Actelion's efforts in the field of selective S1P1 receptor agonists started in 1999 by focusing on receptors found on the endothelium, the inner lining of blood vessels. The result of these research efforts is Actelion's orally active selective S1P1 receptor agonist currently undergoing phase I safety and tolerability testing.
Additional discovery and early pre-clinical development efforts in the field of selective S1P1 receptor agonists are underway at Actelion's research facilities in Allschwil, Switzerland.
Autoimmune disorders are diseases caused by the body producing an immune response against its own tissues. The cause of autoimmune disorders is unknown. Some of the most common types of autoimmune disorders include psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and rejection of transplanted organs. These disorders affect millions of people worldwide.