Lead Compound SC12267 Completing Phase I Clinical Trials
MARTINSRIED, Germany, and GENEVA, May 4 /PRNewswire-FirstCall/ -- 4SC AG
("4SC"), a German-based drug discovery and development company, and Serono
(virt-x: SEO and NYSE: SRA) 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.
About SC12267
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.
About Serono
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).
About 4SC
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.
SOURCE Serono International S.A.
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Related links:
http://www.seronousa.com
http://www.serono.com http://www.4sc.de
CONTACT:
Serono in Geneva, Switzerland, Media,
+41-22-739-36-00, or Fax, +41-22-739-30-85, or Investors,
+41-22-739-36-01, or Fax, +41-22-739-30-22; or Serono, Inc.,
Rockland, MA, Media, +1-781-681-2340, or Fax, +1-781-681-2935, or
Investors, +1-781-681-2552, or fax, +1-781-681-2912; or Bettina
von Klitzing of 4SC AG, +49-89-700-763-0, or fax,
+49-89-700-763-29
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