BioWorld International Correspondent

PARIS - Serono SA and the German drug discovery company 4SC AG signed an agreement granting Geneva-based Serono exclusive worldwide rights to develop and commercialize 4SC's program of dihydroorotate dehydrogenase (DHODH) inhibitors.

The program comprises a number of small molecules with the potential to become orally active treatments for autoimmune disorders such as rheumatoid arthritis and multiple sclerosis. The agreement covers the lead compound in the program, SC12267, which soon will complete a Phase I trial, as well as backup compounds and related intellectual property.

4SC, of Martinsried, will receive an undisclosed up-front payment, research funding and potential milestones related to development stages, regulatory submissions, marketing authorizations and commercial sales targets. Serono's payments to 4SC could total up to $67 million if products are successfully developed, registered and commercialized. In addition, 4SC would receive royalties on product sales.

The Phase I trial of SC12267 will be completed by 4SC, but Serono will be solely responsible for all further development both of that product and any others derived from the collaboration. Serono's head of product development, Franck Latille, said the deal would strengthen the company's "development portfolio in autoimmune diseases, building on our existing commitment to this area of significant medical need."

At 4SC, CEO Ulrich Dauer said that partnering with Serono demonstrated the success of its business model, which is to develop drug candidates for licensing out to larger companies. "Revenues resulting from this partnership will contribute to the sustainable growth of our small-molecule drug discovery and development pipeline," he added.

Meanwhile, Serono Inc., the Swiss company's U.S. subsidiary, has launched Zorbtive, an injectable formulation of the recombinant human growth hormone somatropin (rDNA origin), for the treatment of short-bowel syndrome (SBS). The FDA has granted Serono Inc., of Rockland, Mass., seven-year orphan drug exclusivity for Zorbtive in the treatment of SBS. The drug is designed to reduce the dependence of SBS patients on parenteral nutrition, as many currently spend eight to 10 hours a day hooked up to an intravenous feeding line.