4SC and Serono to develop orally active compounds for autoimmune disorders

4SC, a German-based drug discovery and development company, and Swiss biotech company Serono have signed an agreement under which 4SC has granted Serono exclusive worldwide rights to develop and commercialise its programme of dihydroorotate dehydrogenase (DHODH) inhibitors.

This programme comprises a series of small molecules with potential as orally active treatments in autoimmune disorders, such as rheumatoid arthritis and multiple sclerosis. The agreement covers lead compound SC12267, which is currently completing Phase I clinical trials, as well as further back-up compounds and related intellectual property.

Under the terms of the agreement, 4SC will receive an upfront payment, research funding and potential milestone payments related to development progress, regulatory submissions, marketing authorisations and commercial sales achievements. If products are successfully developed, registered and commercialised 4SC could receive up to US$67m from Serono, as well as undisclosed royalties on product sales.

4SC will be responsible for completion of the current multiple dose Phase I study on SC12267, while Serono will be solely responsible for further development, regulatory approvals and commercialisation, both of SC12267 and of any other products deriving from the collaboration.

'Revenues resulting from this partnership will contribute to the sustainable growth of our small molecule drug discovery and development pipeline,' said Dr Ulrich Dauer, ceo of 4SC.

SC12267 is a novel, selective and orally available, small molecule inhibitor of DHODH that interferes with cell proliferation through blocking the synthesis pathway of pyrimidines. It has shown activity in in vitro and in vivo models. Ongoing Phase I studies indicate favourable pharmacokinetic properties, suggesting a likely once daily dosing regime of the well tolerated compound.