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 May, 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).)
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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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[GRAPHIC OMITED]
Media Release
FOR IMMEDIATE RELEASE
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4SC AG AND SERONO SIGN WORLDWIDE AGREEMENT
TO DEVELOP AND COMMERCIALIZE ORALLY ACTIVE COMPOUNDS
FOR THE TREATMENT OF AUTOIMMUNE DISORDERS
LEAD COMPOUND SC12267 COMPLETING PHASE I CLINICAL TRIALS
MARTINSRIED, GERMANY AND GENEVA, SWITZERLAND - MAY 4, 2004 -
4SC AG ("4SC"), a German-based drug discovery and development company, and
Serono (virt-x: SEO and NYSE: SRA) announced today that they have signed an
agreement under which 4SC grants Serono exclusive worldwide rights to develop
and commercialize 4SC's program of dihydroorotate dehydrogenase (DHODH)
inhibitors. This program comprises a series of small molecules with potential as
orally active treatments in autoimmune disorders, such as rheumatoid arthritis
and multiple sclerosis. The agreement covers lead compound SC12267, which is
currently completing Phase I clinical trials, as well as further back-up
compounds and related intellectual property.
Under the terms of the agreement, 4SC will receive an upfront payment, research
funding and potential milestone payments related to development progress,
regulatory submissions, marketing authorizations and commercial sales
achievements. If products are successfully developed, registered and
commercialized 4SC could receive up to USD 67 million from Serono. 4SC will also
receive undisclosed royalties on product sales.
4SC will be responsible for completion of the current multiple dose Phase I
study on SC12267, while Serono will be solely responsible for further
development, regulatory approvals and commercialization, both of SC12267 and of
any other products deriving from the collaboration.
Dr Ulrich Dauer, CEO of 4SC commented "Gaining Serono as a partner committed to
strongly expanding its presence in autoimmune disorders demonstrates the success
of our business model in providing attractive drug candidates to major
companies". He added "Revenues resulting from this partnership will contribute
to the sustainable growth of our small molecule drug discovery and development
pipeline".
"This partnership with 4SC will further strengthen our development portfolio in
autoimmune diseases, building on Serono's existing commitment to this area of
significant medical need" said Franck Latrille, Serono's Head of Product
Development.
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ABOUT SC12267
SC12267, a novel, selective and orally available, small molecule inhibitor of
dihydroorotate dehydrogenase (DHODH), interferes with cell proliferation through
blocking the synthesis pathway of pyrimidines. Its mode-of-action is of
therapeutic relevance for the treatment of autoimmune disorders such as
rheumatoid arthritis and multiple sclerosis. 4SC was able to reach clinical
trials with SC12267 in less than 3 years through application of its proprietary
virtual screening platform and state of the art discovery capabilities in
medicinal chemistry and relevant disciplines. SC12267 has shown activity in in
vitro and in vivo models. Ongoing Phase I studies indicate favorable
pharmacokinetic properties, suggesting a likely once daily dosing regime of the
well tolerated compound.
ABOUT AUTOIMMUNE DISORDERS
Autoimmune disorders are a severe medical problem. In general they are caused by
an over reactive immune response. Examples of this kind of disorder are multiple
sclerosis (MS) and rheumatoid arthritis (RA). MS is a disease of the central
nervous system (CNS), which includes the brain, the spinal cord and the optic
nerves. It is usually diagnosed between the ages of 20 and 40 and is twice as
common in women as in men. RA is a very common disease affecting almost 6
million people around the world. It is characterized by inflammation of multiple
joints, cartilage loss and bone erosion, which leads to joint destruction and
ultimately reduced joint function. Fewer than 50% of patients diagnosed with RA
can continue to work or function normally on a day to day basis after ten years.
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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 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 25, 2004. 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.
###
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 4SC
4SC is a drug discovery and development company that uses its
cheminformatics-based technological platform for the discovery and development
of new drug candidates. By combining the disciplines of chemistry and biology
with the proprietary virtual High Throughput Screening technology, 4SCan(R), the
time and cost of advancing a drug candidate to the development phase can be
significantly reduced. The company's therapeutic focus centers on
hyperproliferative and infectious diseases. The drug candidate SC12267 for
treatment of rheumatoid arthritis from 4SC's most advanced project is currently
being tested in clinical Phase I. Additional research programs in disease areas
of cancer, inflammation, and bacterial infections are currently at the discovery
and preclinical evaluation stage. 4SC, which was founded in 1997, today employs
60 people and is based in Martinsried, near Munich, Germany.
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:
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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4SC AG
Bettina von Klitzing
Tel: +49-89-700 763 0
Fax: +49-89-700 763 29
http://www.4sc.de
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[GRAPHIC OMITED]
Media Release
FOR IMMEDIATE RELEASE
---------------------
SERONO LAUNCHES ZORBTIVE(TM), FIRST DRUG PRODUCT FOR TREATMENT OF
SHORT BOWEL SYNDROME
USE OF RECOMBINANT HUMAN GROWTH HORMONE REDUCES PATIENT DEPENDENCE ON PARENTERAL
NUTRITION
GENEVA, SWITZERLAND AND ROCKLAND, MA, MAY 4, 2004 - SERONO (VIRT-X: SEO AND
NYSE: SRA) -Serono, Inc., the US affiliate of Serono, announced today the
launch of Zorbtive(TM) [somatropin (rDNA origin) for injection] for use in the
treatment of patients with short bowel syndrome.
Short bowel syndrome (SBS) is a rare and potentially life-threatening condition
in which the ability of the small intestine to absorb the nutrition a person
needs from food is impaired. Short bowel syndrome can occur after surgical
removal of part of the intestine, due to trauma or because the intestine is
diseased.
"Many patients with SBS receive their basic nourishment by parenteral nutrition,
which means they can spend eight to ten hours a day hooked up to an intravenous
feeding line," says Kareem M. Abu-Elmagd, MD, PhD, FACS, Professor of Surgery,
Director of The Intestinal Rehabilitation and Transplant Center at the Thomas E.
Starzl Transplantation Institute in Pittsburgh, Pennsylvania. "Reduction in
dependence on parenteral nutrition is an important therapeutic goal for
patients. Treatment with Zorbtive(TM) may help to achieve this."
Results from a pivotal clinical trial showed that a four-week regimen of
Zorbtive(TM), Serono's brand of recombinant human growth hormone for use in SBS
given in conjunction with specialized nutritional support, could significantly
reduce a person's dependence on intravenous feeding as measured by total volume,
total calories and frequency of infusion. Patients taking Zorbtive(TM) and a
supplemented specialized diet reduced the average number of days they had to use
intravenous nutrition by 4.2 days per week versus baseline, which was a
significant reduction compared to the average reduction seen in the control
group. Additionally, the proportion of patients who were able to completely
discontinue intravenous feeding was greater among those who received
Zorbtive(TM). Results persisted at the 12-week post-treatment follow-up
assessment.
There are an estimated 10,000-20,000 people in the US who are receiving
intravenous parenteral nutrition for SBS who could potentially benefit from
Zorbtive(TM) treatment. Zorbtive(TM) was granted a seven-year orphan drug
exclusivity for use in the treatment of patients with SBS by the US Food and
Drug Administration.
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ADDITIONAL PRODUCT INFORMATION
Zorbtive(TM) is the only drug product approved by the US Food and Drug
Administration specifically for the treatment of SBS in patients receiving
specialized nutritional support. Optimal management of SBS may include dietary
adjustments, enteral feedings, parenteral nutrition, and fluid and micronutrient
supplements, as needed. The recommended dose is 0.1 mg/kg daily up to a maximum
of 8 mg per day for a treatment period of four weeks. Zorbtive(TM) is available
in an 8.8 mg vial and is administered by subcutaneous injection.
The most commonly reported adverse events during the clinical trial included
mild injection-site reactions, gastrointestinal disturbances, muscle and joint
pain, and edema/swelling. Patients with a history of hyperglycemia or other
risk factors for glucose intolerance should be monitored closely. Transient
increases in glucose levels occur early in treatment and should be monitored.
Use of growth hormone is contraindicated in treatment of patients in intensive
care units due to complications following open-heart surgery or abdominal
surgery, multiple accidental trauma or acute respiratory failure; patients with
active neoplasia; and patients with known hypersensitivity to growth hormone.
More information about Zorbtive(TM) can be found in the full prescribing
information and Treatment Guideline available online at www.zorbtive.com or by
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calling SeroCare at 1-800-714-2437. Patients should be instructed to read the
Patient Handbook and the patient package insert leaflet accompanying the
product.
2/3
ABOUT SERONO
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global
biotechnology leader, headquartered in Geneva, Switzerland. Serono has seven
recombinant products, Rebif(R) (interferon beta-1a), Gonal-F(R) (follitropin
alfa for injection), Luveris(R) (lutropin alfa), Ovidrel(R)/Ovitrelle(R)
(choriogonadotropin alfa injection), Serostim(R) [somatropin (rDNA origin) for
injection], Saizen(R) [somatropin (rDNA origin) for injection] and Zorbtive(TM)
[somatropin (rDNA origin) for injection]. (Luveris(R) is not approved in the
USA.)(1) In addition to being the world leader in reproductive health, Serono
has strong market positions in neurology, metabolism and growth. Serono'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).
###
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 25, 2004. 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.
###
FOR MORE INFORMATION, PLEASE CONTACT:
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel. +1 781 681 2481 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
------------------------
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: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
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(1) Package inserts for Serono's US marketed products are available at
www.seronousa.com or by calling 1-888-275-7376.
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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)
May 4, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary