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 August, 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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GENMAB SERONO
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO AND GENMAB ANNOUNCE GLOBAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
FOR HUMAX-CD4
HuMax-CD4 currently in Phase III Clinical Trial for Cutaneous T-Cell Lymphoma
and Phase II Clinical Trial for Non-Cutaneous T-Cell Lymphoma
GENEVA, SWITZERLAND AND COPENHAGEN, DENMARK - AUGUST 18, 2005 -
Serono (virt-x: SEO and NYSE: SRA) and Genmab A/S (CSE: GEN) announced today an
agreement under which Genmab has granted Serono exclusive worldwide rights to
develop and commercialize Genmab's HuMax-CD4. HuMax-CD4 is a fully human
monoclonal antibody in development for the treatment of cutaneous and
non-cutaneous T-cell lymphomas. It is currently being evaluated in a pivotal
Phase III clinical trial for cutaneous T-cell lymphoma (CTCL) under the US Food
and Drug Administration's Special Protocol Assessment process and has Fast Track
designation from the FDA. HuMax-CD4 is also being studied in a Phase II trial
for non-cutaneous T-cell lymphoma (NCTCL). HuMax-CD4 is directed against the CD4
antigen and causes depletion of certain T-cells through antibody-dependent
cellular cytotoxicity.
Under the terms of the agreement, Genmab will receive a license fee of USD 20
million, and Serono will make a USD 50 million investment in Genmab common
stock, at a premium to the market price. Genmab may receive up to USD 215
million in total payments, including the initial license fee and equity
purchase, milestone payments for regulatory submissions and approvals of
HuMax-CD4 in CTCL and NCTCL in the US, Europe and Japan, and payments based on
the achievement of certain sales milestones. Genmab will be entitled to receive
royalties on global sales of HuMax-CD4. Serono will be responsible for all
future development costs for HuMax-CD4 and for future manufacturing of the
product. Genmab will continue to conduct the ongoing clinical trials as
described above.
"Serono's proficiency in bringing biotechnology products to market as well as
their established presence in highly specialized dermatology clinics, which play
a significant role in the diagnosis and treatment of CTCL, makes the company an
excellent strategic partner," said Lisa N. Drakeman, Ph.D., Chief Executive
Officer of Genmab.
"We are committed to building a strong oncology pipeline through partnerships
with leading companies such as Genmab, and through our own internal research,"
said Ernesto Bertarelli, Chief Executive Officer of Serono. "HuMax-CD4 is an
important addition to Serono's oncology portfolio, which now consists of four
different clinical-stage products being investigated across a broad range of
indications."
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Simultaneously with this release, Genmab will publish a separate stock exchange
release containing more information regarding the placement of Genmab shares to
Serono, which is made in direct connection with the Global Development and
Commercialization Agreement regarding HuMax-CD4.
ABOUT CTCL AND NCTCL
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Cutaneous T-cell lymphomas (CTCL) are a group of lymphomas characterized by
abnormal accumulation of malignant T-cells in the skin, potentially resulting in
the development of rashes, plaques and tumors. The most common types of CTCL
include mycosis fungoides (MF) and Sezary syndrome (SS). CTCL result from
errors in the production of T-lymphocytes or transformation of T-lymphocytes
into malignant cells. Abnormal, uncontrolled growth and multiplication of
malignant T-lymphocytes result in accumulation of these lymphocytes in the skin
and may in some cases spread and affect the lymph nodes and other body tissues
and organs, resulting in life-threatening complications.
Non-cutaneous T-cell lymphomas (NCTCL) are defined by highly malignant disease,
which has localized to the lymph nodes even at the earliest stage of
presentation, and include angioimmunoblastic T-cell lymphoma, anaplastic large
cell lymphoma (ALCL) and unspecified peripheral T-cell lymphoma. NCTCL is
characterized by aggressive progression with average survival time of
approximately two years.
ABOUT HUMAX-CD4 (ZANOLIMUMAB)
-------------------------------
HuMax-CD4 is a human monoclonal antibody currently in Phase III development for
cutaneous T-cell lymphoma (CTCL) and in Phase II for non-cutaneous T-cell
lymphoma. These types of lymphomas express the CD4 receptor, which is the target
of HuMax-CD4. In April 2005, Genmab and the United States Food and Drug
Administration (FDA) reached an agreement on the design of its pivotal study
protocol for HuMax-CD4 to treat CTCL under the Special Protocol Assessment
process (SPA). The pivotal study will include patients with mycosis fungoides
(MF) who are refractory to or intolerant of Targretin(R) and one other standard
therapy, and will treat a total of 88 patients.
In March 2004, Genmab announced that HuMax-CD4 had been designated a Fast Track
Product by the US Food and Drug Administration (FDA). This designation covers
patients with CTCL for whom no available therapy exists, i.e. have failed at
least two systemic treatment regimens. HuMax-CD4 for the treatment of MF has
also been granted Orphan Drug status in the US and Europe.
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GENMAB FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. The words "believe",
"expect", "anticipate", "intend" and "plan" and similar expressions identify
forward looking statements. Actual results or performance may differ materially
from any future results or performance expressed or implied by such statements.
The important factors that could cause our actual results or performance to
differ materially include, among others, risks associated with product discovery
and development, uncertainties related to the outcome and conduct of clinical
trials including unforeseen safety issues, uncertainties related to product
manufacturing, the lack of market acceptance of our products, our inability to
manage growth, the competitive environment in relation to our business area and
markets, our inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and proprietary rights,
our relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other factors. Genmab is
not under an obligation to up-date statements regarding the future following the
publication of this release; nor to confirm such statements in relation to
actual results, unless this is required by law.
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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.
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ABOUT GENMAB A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies
for the treatment of life-threatening and debilitating diseases. Genmab has
numerous products in development to treat cancer, infectious disease, rheumatoid
arthritis and other inflammatory conditions, and intends to continue assembling
a broad portfolio of new therapeutic products. At present, Genmab has multiple
partnerships to gain access to disease targets and develop novel human
antibodies including agreements with Roche and Amgen. A broad alliance provides
Genmab with access to Medarex, Inc.'s array of proprietary technologies,
including the UltiMAb(R) platform for the rapid creation and development of
human antibodies to virtually any disease target. Genmab has operations in
Copenhagen, Denmark, Utrecht, the Netherlands, and Princeton, New Jersey in the
US. For more information about Genmab, visit www.genmab.com.
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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).
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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GENMAB
Helle Husted
Director, Investor Relations
T: +45 33 44 77 30
M: +45 25 27 47 13
E: hth@genmab.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)
August 18, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer