SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of October, 2005
Serono S.A.
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(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
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(Address of Principal Executive Offices)
1-15096
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(Commission File No.)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.)
Form 20-F X Form 40-F
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(1).)
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(7).)
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(Indicate by check mark whether the registrant by furnishing the
information contained in this form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes No X
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(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82- )
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CancerVax(TM) Serono
Media Release
FOR IMMEDIATE RELEASE
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DATA AND SAFETY MONITORING BOARD RECOMMENDS
DISCONTINUATION OF CANVAXIN(TM) PHASE 3 CLINICAL TRIAL
FOR PATIENTS WITH STAGE III MELANOMA
GENEVA, SWITZERLAND AND CARLSBAD, CALIFORNIA, USA - OCTOBER 3, 2005 - 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.
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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).
ABOUT CANCERVAX CORPORATION (WWW.CANCERVAX.COM)
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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 (617) 213-8858
(international). The passcode is 70660579. A replay of the conference call can
be accessed by dialing (888) 286-8010 (domestic) or (617) 801-6888
(international). The passcode for the replay is 42654318. The webcast will also
be archived on CancerVax's website.
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FORWARD-LOOKING STATEMENTS
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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.
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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.
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CancerVax(R) is a registered trademark of CancerVax Corporation.
Canvaxin(TM) is a trademark of CancerVax Corporation.
FOR MORE INFORMATION, PLEASE CONTACT:
SERONO
CORPORATE MEDIA RELATIONS: CORPORATE INVESTOR RELATIONS:
Tel: +41 22 739 36 00 Tel: +41 22 739 36 01
Fax: +41 22 739 30 85 Fax: +41 22 739 30 22
http://www.serono.com Reuters: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA:
Tel: +1 781 681 2340 Tel: +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
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CANCERVAX CONTACT:
William R. La Rue
CancerVax Corporation
Chief Financial Officer
+1 760-494-4200
http://www.cancervax.com
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SERONO S.A.
a Swiss corporation
(Registrant)
October 3, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer