SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________
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 February, 2004
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).) ______
(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).) ______
(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-______)
SERONO INDEX
Pharmaceuticals AB
Media Release
FOR IMMEDIATE RELEASE
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SERONO AND SWEDISH BIOTECH COMPANY INDEX PHARMACEUTICALS
SIGN WORLDWIDE AGREEMENT TO DEVELOP AND COMMERCIALIZE
NOVEL ULCERATIVE COLITIS TREATMENT
AGREEMENT FOR NOVEL GASTROENTEROLOGY THERAPY CURRENTLY IN PHASE II
GENEVA, SWITZERLAND AND STOCKHOLM, SWEDEN - FEBRUARY 24, 2004 -
Serono (virt-x: SEO and NYSE: SRA) and InDex Pharmaceuticals AB ("InDex")
announced today that they have signed an agreement under which Serono receives
exclusive worldwide rights to develop and commercialize InDex' product
Kappaproct(R) for the treatment of ulcerative colitis and potentially other
inflammatory diseases. Kappaproct(R) is an antisense inhibitor of the p65
protein, a key activator of the pro-inflammatory NF-kappa B pathway.
Under the terms of the agreement, InDex will receive an initial fee upon the
effective date of the agreement and potential milestone payments related to
development progress, regulatory submissions and approvals, as well as research
and development funding. If Kappaproct(R) is successfully developed and
registered worldwide in at least one indication, the aggregate amount of these
payments could reach USD35 million. InDex will also receive undisclosed
royalties on sales of Kappaproct(R).
"Ulcerative colitis is a severe debilitating disease and represents a high unmet
medical need," said Franck Latrille, Serono's Senior Executive Vice President
Global Product Development. "Kappaproct(R) has the potential to be a significant
breakthrough by inducing clinical remission in patients with active ulcerative
colitis without compromising safety."
"As one of the world's leading biotechnology companies, Serono has an impressive
track record in the development and marketing of innovative therapeutics," said
Svante Rasmuson, CEO of InDex Pharmaceuticals. "We are confident that in Serono
we have found a strong and committed partner for completing development of this
novel approach to the treatment of ulcerative colitis".
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Kappaproct(R) is currently being tested in a Phase II clinical trial for active
ulcerative colitis which will involve 150 patients. In a completed
proof-of-concept, double-blind placebo-controlled clinical trial in patients
with therapy-resistant inflammatory bowel disease, it was shown that the
majority of these patients responded positively to a single dose of
Kappaproct(R). Patients receiving Kappaproct(R) experienced only mild adverse
effects.
Kappaproct(R) is being developed for the treatment of ulcerative colitis, a
chronic inflammatory condition involving the large bowel. This disease mainly
affects young people, with disease onset typically occurring between the ages of
20 and 30 years. The most common symptoms of ulcerative colitis are abdominal
discomfort and frequent loose stools. Patients may also experience fatigue,
weight loss, loss of appetite, rectal bleeding, loss of body fluids and
nutrients. Severely affected patients experience fever, bloody diarrhea, nausea,
and abdominal cramps. Ulcerative colitis may also cause non-intestinal problems
such as arthritis, inflammation of the eye, liver disease and anemia. Disease
management is a long-term commitment for both patient and physician, since there
is currently no cure for this condition. In a majority of cases, the disease may
be controlled with conventional drugs, including 5-aminosalicylic acid (5-ASA)
and glucocorticosteroids. However, between 25 and 40 percent of ulcerative
colitis patients are unresponsive to such treatment, and ultimately require
surgical resection of the colon. Patients with long-standing ulcerative colitis
disease are at considerable risk of developing colorectal cancer.
###
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 April 17, 2003. 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.
###
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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 INDEX PHARMACEUTICALS
InDex Pharmaceuticals develops antisense therapeutics and diagnostic/prognostic
tools for unmet medical needs within inflammation and cancer. The company,
located at Karolinska Institutet in Stockholm, was incorporated in December 2000
and has currently a staff of 26 people. Main shareholders are SEB Foretagsinvest
and Life Equity Sweden.
The company's corporate mission is to break new ground in innovative therapies
and thus become a preferred R&D partner to large industry players in the
biopharmaceutical area. The first product Kappaproct(R), developed for the
treatment of inflammatory bowel disease, has entered into phase II clinical
trials for active ulcerative colitis.
Research activities are focused on development of antisense drugs. Antisense
represents an expansion of conventional pharmacology in combination with new
findings within molecular biology. Consequently, a new class of drugs has been
created with a different approach, but the antisense technology itself also
implies a more rational design of new drugs.
FOR MORE INFORMATION, PLEASE CONTACT:
SERONO IN GENEVA, SWITZERLAND:
MEDIA RELATIONS: 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: SEOZ.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
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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INDEX PHARMACEUTICALS, STOCKHOLM, SWEDEN:
Tel: +46-8-50 88 47 30
Fax: +46-8-50 88 47 39
http://www.indexpharmab.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)
February 24, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer