GENEVA, Switzerland and CARLSBAD, California, October 3
/PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) and CancerVax
Corporation (NASDAQ: CNVX) announced today their decision to discontinue the
Phase 3 clinical trial of Canvaxin(TM) in patients with Stage III melanoma
based upon the recommendation of the independent Data and Safety Monitoring
Board (DSMB), which recently completed its planned, third, interim analysis
of the data from this study. The DSMB found that the data are unlikely to
provide significant evidence of an overall survival benefit for patients with
Stage III melanoma who were treated with Canvaxin(TM) versus those who
received placebo.
    "This news is particularly disappointing because we understand the
devastating impact of this disease on patients with advanced-stage melanoma,
as well as their families and friends. We are extremely grateful for the
strong support we have received for this clinical trial from the clinicians,
nurses, study coordinators and, especially, the patients who participated in
this clinical trial," said David F. Hale, President and CEO of CancerVax
Corporation. "We will discontinue all further development and manufacturing
operations for Canvaxin(TM), but we currently plan to continue to further the
development of the other product candidates in our product pipeline, which we
believe hold promise for the treatment of patients with cancer."
    "The Phase 2 results were promising, and we were thus hopeful that this
highly innovative product would be successful in a Phase 3 clinical trial in
patients with Stage III melanoma," said Franck Latrille, Senior Executive
Vice President, Corporate Global Product Development of Serono. "We continue
to have a strong pipeline with five Phase 3 programs and significant newsflow
expected in the next year. Serono remains committed to oncology with
Humax-CD4, adecatumumab and TACI-Ig with study results from all three
programs expected in 2006."
    There were no significant safety issues identified with either the Phase
3 clinical trial of Canvaxin(TM) in patients with Stage III melanoma, or with
the Phase 3 clinical trial of Canvaxin(TM) in patients with Stage IV
melanoma, which was discontinued earlier this year. The recommendations to
close both of these clinical trials were not made because of any potential
safety concerns. Once the data from these clinical trials are fully analyzed,
they will be presented at appropriate scientific meetings.
    About the DSMB and Interim Analyses
    The DSMB consists of independent experts in medical and surgical
oncology, statistics and medical ethics who are not participating in the
clinical trials, whose primary responsibility is to monitor, on a periodic
basis, the data emerging from a clinical trial and to provide recommendations
to the sponsor on whether a study should be modified or discontinued.
    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).
    http://www.serono.com
    About CancerVax Corporation (http://www.cancervax.com)
    CancerVax Corporation is a biotechnology company focused on the research,
development and commercialization of novel biological products for the
treatment and control of cancer. CancerVax has been evaluating Canvaxin(TM)
in a Phase 3 clinical trial for the treatment of patients with Stage III
melanoma in collaboration with Serono. CancerVax also has a pipeline of
product candidates and technologies that are being developed for the
potential treatment of cancer. These include SAI-EGF, a product candidate
that targets the epidermal growth factor (EGF) receptor signaling pathway;
and D93, CancerVax's lead anti-angiogenic humanized monoclonal antibody.
CancerVax plans to file an Investigational New Drug (IND) application for
clinical trials of D93 in early 2006, and to initiate a clinical trial with
SAI-EGF in patients with advanced non-small-cell lung cancer in 2006.
    CANCERVAX CORPORATION
    CONFERENCE CALL AND WEBCAST TUESDAY, OCTOBER 4, AT 9:00 EASTERN TIME
    CancerVax management will host a conference call on Tuesday, October 4,
at 9:00 a.m. Eastern Time to discuss the DSMB recommendation to discontinue
the Canvaxin Phase 3 clinical trial for patients with Stage III melanoma. A
live audio webcast of management's presentation will be available at
http://ir.cancervax.com. Alternatively, callers may participate in the
conference call by dialing (866)-831-6270 (domestic) or +1-(617)-213-8858
(international). The passcode is 70660579. A replay of the conference call
can be accessed by dialing (888) 286-8010 (domestic) or +1-(617)-801-6888
(international). The passcode for the replay is 42654318. The webcast will
also be archived on CancerVax's website.
    Forward-Looking Statements
    Serono
    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.
    CancerVax Corporation
    CancerVax cautions you that statements included in this press release
that are not a description of historical facts are forward-looking
statements. For example, statements about the timing of the initiation of
clinical trials with any of CancerVax's product candidates, and plans and
objectives of management, are all forward-looking statements. The inclusion
of forward-looking statements should not be regarded as a representation by
CancerVax that any of its plans will be achieved. Actual results may differ
materially from those set forth in this release due to the risks and
uncertainties inherent in CancerVax's business including, without limitation:
the progress, timing and outcome of its clinical trials; its ability to
obtain additional financing to support its operations, which could adversely
affect its ability to continue to operate as a going concern; the risk that
the collaboration agreement for Canvaxin(TM) may be terminated by Serono in
certain instances; the risk that CancerVax may be required to pre-pay the
debt incurred to expand its manufacturing capacity prior to the termination
of the loan because of a failure to comply with covenants included in the
loan agreement; unexpected adverse side effects or inadequate therapeutic
efficacy of its product candidates that could delay or prevent product
development or commercialization, or that could result in recalls or product
liability claims; competition from other pharmaceutical or biotechnology
companies; CancerVax's limited experience in manufacturing and testing
biological products, which may result in delayed development or
commercialization of its product candidates, as well as lost revenue; and
other risks detailed in CancerVax's Securities and Exchange Commission
filings, including CancerVax's Annual Report on Form 10-K for the fiscal year
ended December 31, 2004, and Quarterly Report for the fiscal quarter ended
June 30, 2005. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary
statement and CancerVax undertakes no obligation to revise or update this
news release to reflect events or circumstances after the date hereof. This
caution is made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995.
    CancerVax(R) is a registered trademark of CancerVax Corporation.
    Canvaxin(TM) is a trademark of CancerVax Corporation.

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