Lead Compound SC12267 Completing Phase I Clinical Trials
May 4, 2004
Source: Serono International S.A.
4SC AG, a German-based drug discovery and development company, and Serono announced today that they have signed an agreement under which 4SC grants Serono exclusive worldwide rights to develop and commercialize 4SC's program of dihydroorotate dehydrogenase (DHODH) inhibitors. This program 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 authorizations and commercial sales achievements. If products are successfully developed, registered and commercialized 4SC could receive up to USD 67 million from Serono. 4SC will also receive 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 commercialization, both of SC12267 and of any other products deriving from the collaboration.
Dr Ulrich Dauer, CEO of 4SC commented "Gaining Serono as a partner committed to strongly expanding its presence in autoimmune disorders demonstrates the success of our business model in providing attractive drug candidates to major companies". He added "Revenues resulting from this partnership will contribute to the sustainable growth of our small molecule drug discovery and development pipeline".
"This partnership with 4SC will further strengthen our development portfolio in autoimmune diseases, building on Serono's existing commitment to this area of significant medical need" said Franck Latrille, Serono's Head of Product Development.
SC12267, a novel, selective and orally available, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH), interferes with cell proliferation through blocking the synthesis pathway of pyrimidines. Its mode-of-action is of therapeutic relevance for the treatment of autoimmune disorders such as rheumatoid arthritis and multiple sclerosis. 4SC was able to reach clinical trials with SC12267 in less than 3 years through application of its proprietary virtual screening platform and state of the art discovery capabilities in medicinal chemistry and relevant disciplines. SC12267 has shown activity in in vitro and in vivo models. Ongoing Phase I studies indicate favorable pharmacokinetic properties, suggesting a likely once daily dosing regime of the well tolerated compound.
About autoimmune disorders
Autoimmune disorders are a severe medical problem. In general they are caused by an over reactive immune response. Examples of this kind of disorder are multiple sclerosis (MS) and rheumatoid arthritis (RA). MS is a disease of the central nervous system (CNS), which includes the brain, the spinal cord and the optic nerves. It is usually diagnosed between the ages of 20 and 40 and is twice as common in women as in men. RA is a very common disease affecting almost 6 million people around the world. It is characterized by inflammation of multiple joints, cartilage loss and bone erosion, which leads to joint destruction and ultimately reduced joint function. Fewer than 50% of patients diagnosed with RA can continue to work or function normally on a day to day basis after ten years.
Serono forward-looking statements
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2004. These factors include any failure or delay in Serono's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. Serono has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
Serono is a global biotechnology leader. The Company has seven recombinant products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Serostim(R), Saizen(R) and Zorbtive(TM) (Luveris(R) is not approved in the USA). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are approximately 30 ongoing development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net income of US$390.0 million, making it the third largest biotech company in the world. Its products are sold in over 90 countries. Bearer shares of Serono S.A., the holding company, are traded on the virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
4SC is a drug discovery and development company that uses its cheminformatics-based
technological platform for the discovery and development of new drug candidates.
By combining the disciplines of chemistry and biology with the proprietary
virtual High Throughput Screening technology, 4SCan(R), the time and cost
of advancing a drug candidate to the development phase can be significantly
reduced. The company's therapeutic focus centers on hyperproliferative
and infectious diseases. The drug candidate SC12267 for treatment of rheumatoid
arthritis from 4SC's most advanced project is currently being tested in
clinical Phase I. Additional research programs in disease areas of cancer,
inflammation, and bacterial infections are currently at the discovery and
preclinical evaluation stage. 4SC, which was founded in 1997, today employs
60 people and is based in Martinsried, near Munich, Germany.
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