Serono and Rigel Sign Agreement to Develop and Commercialize Aurora Kinase Inhibitors
October 25 2005 - 2:01AM
PR Newswire (US)
Rigel to File IND for Lead Product Candidate R763 by end of 2005
SOUTH SAN FRANCISCO, California and GENEVA, Switzerland, October 25
/PRNewswire-FirstCall/ -- Rigel Pharmaceuticals, Inc (NASDAQ:RIGL)
and Serono (virt-x: SEO and NYSE: SRA) today announced that they
have signed an agreement under which Serono has been granted an
exclusive license to develop and commercialize product candidates
from Rigel's Aurora kinase inhibitor program. The license is
worldwide, except for Japan, which Serono has an option to include
at any time within the next two years. Rigel's Aurora kinase
inhibitor program includes R763, for which Rigel expects to file an
investigational new drug (IND) application in December 2005. R763
is a highly potent, orally-available multi-Aurora kinase inhibitor
that has been shown in vitro and in in vivo tumor xenograft models
to inhibit proliferation and trigger apoptosis in several tumor
cell lines including the cervix, colon, lung, pancreas and
prostate. Under the terms of the agreement, Rigel will receive
initial payments totaling $25 million, comprised of a license fee
of $10 million and purchase of $15 million of Rigel's common stock,
at a premium to the market price. With additional development and
sales-based milestone payments for R763, Rigel could receive up to
$160 million in total, as well as royalties on any eventual product
sales of R763 and other Aurora kinase inhibitors developed under
the agreement. Serono will be responsible for the further
development and commercialization of R763, as well as any other
product candidates arising from Rigel's Aurora kinase inhibitor
program. "This partnership with Rigel further strengthens our
portfolio of R&D projects in oncology, and confirms our
commitment to develop specialist drugs to tackle significant areas
of unmet medical need", said Dr Tim Wells, Senior Executive Vice
President, Research and Development, Serono. "We believe that
inhibition of Aurora kinase is a promising approach to treating
cancer and Rigel has produced some of the most promising candidates
we have seen. We look forward to moving R763 into the clinic in
2006." "Serono has been extraordinarily proactive in building and
advancing its portfolio in oncology," said Donald G Payan, MD,
Executive Vice President and Chief Scientific Officer of Rigel.
"R763 is a potent, selective inhibitor of Aurora kinase and fits
well into Serono's oncology strategy. We are confident that Serono
will be equally proactive in realizing the potential of this
product candidate." Aurora Kinase and Cancer The over-expression of
Aurora kinase can cause cells to rapidly develop an abnormal number
of chromosomes. Elevated levels of Aurora kinase are frequently
associated with various human cancers, such as cancers of the
breast, bladder, colon, ovary, head and neck, and pancreas.
Inhibition of Aurora kinase arrests cell division and promotes
programmed cell death (apoptosis). Increased knowledge of Aurora
kinase and its regulation may result in future treatments for
cancer. Rigel's lead oncology drug candidate, R763, is a highly
potent inhibitor of Aurora kinase, that has been shown to potently
inhibit proliferation and trigger apoptosis in several tumor cell
lines including cervix, colon, lung, pancreas and prostate. Rigel
discovered R763 using its proprietary cell-based PAD assays applied
to tumor cell lines. About Serono Serono is a global biotechnology
leader. The Company has eight biotechnology products, Rebif(R),
Gonal-f(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Serostim(R),
Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the
world leader in reproductive health, Serono has strong market
positions in neurology, metabolism and growth and has recently
entered the psoriasis area. The Company's research programs are
focused on growing these businesses and on establishing new
therapeutic areas, including oncology. Currently, there are
approximately 30 ongoing development projects. In 2004, Serono
achieved worldwide revenues of US$2,458.1 million, and a net income
of US$494.2 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 Rigel Rigel is a late-stage
drug development company that discovers and develops novel,
small-molecule drugs for the treatment of inflammatory diseases,
cancer and viral diseases. Our goal is to move one new product
candidate for a significant indication into the clinic each year.
We have achieved this goal since 2002. Our pioneering research
focuses on intracellular signaling pathways and related targets
that are critical to disease mechanisms. Rigel's productivity has
resulted in strategic collaborations with large pharmaceutical
partners to develop and market our product candidates. We have
three product development programs in allergy/asthma, rheumatoid
arthritis and cancer. The agreement with Serono represents Rigel's
fifth collaboration in oncology. Rigel has signed oncology
partnerships with Merck on various ubiquitin ligase targets (signed
2004), Daiichi on a specific ubiquitin ligase target (2002),
Novartis on anti-angiogenesis targets (2000) and Johnson &
Johnson on cell cycle inhibition (1998). In addition, this is
Rigel's third major collaboration in the last 12 months. 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
S.A. 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 16, 2005. 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, the outcome of government
investigations and litigation 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. Rigel Forward-looking statements This press
release contains "forward-looking" statements, including statements
related to Rigel's potential receipt of milestone and royalty
payments for R763 and royalties on global sales and the potential
efficacy of product candidates. Any statements contained in this
press release that are not statements of historical fact may be
deemed to be forward-looking statements. Words such as "plans,"
"intends," "expects" and similar expressions are intended to
identify these forward-looking statements. There are a number of
important factors that could cause Rigel's results to differ
materially from those indicated by these forward-looking
statements, including risks associated with the timing and success
of pre-clinical or clinical development or commercialization of the
affected product candidates or research programs, as well as other
risks detailed from time to time in Rigel's SEC reports, including
its Quarterly Report on Form 10-Q for the quarter ended June 30,
2005. Rigel does not undertake any obligation to update
forward-looking statements. DATASOURCE: Serono International S.A.
CONTACT: Serono in Geneva, Switzerland: Media Relations: Tel:
+41-22-739-36-00, Fax: +41-22-739-30-85; Investor Relations: Tel:
+41-22-739-36-01, Fax: +41-22-739-30-22, Media Relations: Tel.
+1-781-681-2340, Fax: +1-781-681-2935, Investor Relations: Tel.
+1-781-681-2552, Fax: +1-781-681-2912. Rigel Pharmaceuticals
Contact: Raul Rodriguez, Phone: +1-650-624-1302 Email: , Media
Contact: Carolyn Bumgardner Wang, WeissComm Partners, Inc., Phone:
+1-415-946-1065, Email:
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