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 May, 2005
Serono S.A.
-----------------------------------------------
(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
---------------------------------------
(Address of Principal Executive Offices)
1-15096
-------------------------
(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
--- ----
(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
---- ----
(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82- )
------
[GRAPHIC OMITED]
SERONO BIOMARIN
MEDIA RELEASE
FOR IMMEDIATE RELEASE
---------------------
BIOMARIN AND SERONO FORM STRATEGIC ALLIANCE FOR
THE DEVELOPMENT AND COMMERCIALIZATION OF PHENOPTIN(TM) AND PHENYLASE(TM)
PHENOPTIN CURRENTLY IN PHASE 3 TRIALS
NOVATO, CALIFORNIA, AND GENEVA, SWITZERLAND, MAY 16, 2005 - BioMarin
Pharmaceutical Inc. (Nasdaq and SWX: BMRN) and Serono (virt-x: SEO and NYSE:
SRA) announced today that they have formed a strategic alliance for the further
development and commercialization of two BioMarin product candidates, Phenoptin
(sapropterin hydrochloride) and Phenylase (phenylalanine ammonia lyase). Both
products have shown potential in the treatment of phenylketonuria (PKU), and
there is preliminary clinical evidence that suggests that the active ingredient
in Phenoptin, a synthetic form of the naturally occurring enzyme cofactor
6R-BH4, may also be useful in the treatment of other serious diseases, including
diabetes and cardiovascular diseases.
By the terms of their agreement, Serono acquires exclusive rights to market the
products in all territories outside the United States and Japan. BioMarin
retains exclusive rights to market the products in the United States. Serono
will make an upfront payment of $25 million to BioMarin, and will make
additional milestone payments of up to $232 million based on the successful
development and registration of both products in multiple indications, of which
$45 million are associated specifically with Phenoptin in PKU. Serono will also
pay BioMarin undisclosed royalties on its net sales of the products. The
companies will share equally all development costs following successful
completion of Phase 2 trials for each product candidate in each indication.
BioMarin is currently investigating Phenoptin, an orally administered product,
in a Phase 3 clinical trial for the treatment of PKU. PKU is an inherited
metabolic disease caused by a deficiency of the enzyme phenylalanine
hydroxylase, resulting in elevated levels of phenylalanine in the blood, which
can result in serious neurological damage. There is currently no approved drug
to treat PKU, which affects at least 50,000 diagnosed patients under the age of
40 worldwide. Phenylase, an enzyme substitution therapy for the treatment of
severe forms of PKU, is currently in preclinical development.
Emil Kakkis MD, PhD, Senior Vice President of Business Operations at BioMarin
commented, "We are very pleased to enter into this partnership with Serono, a
top-tier biotechnology company with strong global development capabilities and
commercial operations. Serono's expertise in developing and marketing novel
products for metabolic and genetic diseases will be an invaluable asset for this
partnership."
"We are delighted to partner with BioMarin for the further development and
commercialization of Phenoptin and Phenylase, products that fit very nicely into
our metabolic endocrinology franchise," said Franck Latrille, Senior Executive
Vice President Global Product Development at Serono. "PKU is a severely
debilitating condition afflicting patients from birth and throughout their
lives. Serono's strategy is to invest in bringing to market innovative products
like Phenoptin and Phenylase that address significant unmet medical needs."
1/3
ABOUT BIOMARIN
BioMarin develops and commercializes innovative biopharmaceuticals for serious
diseases and medical conditions. The company's product portfolio is comprised of
two approved products, Aldurazyme(R) (laronidase) for mucopolysaccharidosis I
(MPS I), and Orapred(R) (prednisolone sodium phosphate oral solution) for severe
asthma, and multiple product candidates including rhASB (galsulfase), a
BLA/MAA-stage product candidate for the treatment of mucopolysaccharidosis VI
(MPS VI), and Phenoptin(TM) (sapropterin hydrochloride), a Phase 3 product
candidate for the treatment of phenylketonuria (PKU). For additional
information, please visit www.BMRN.com. Information on BioMarin's website is
------------
not incorporated by reference into this press release.
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).
#####
FORWARD-LOOKING STATEMENTS
FOR BIOMARIN
This press release contains forward-looking statements about the business
prospects of BioMarin Pharmaceutical Inc., including, without limitation,
statements about: the development of its product candidates Phenoptin and
Phenylase; expectations related to the possible use of Phenoptin for the
treatment of indications other than PKU; and the possible milestone revenue from
development of these product candidates. These forward-looking statements are
predictions and involve risks and uncertainties such that actual results may
differ materially from these statements. These risks and uncertainties include,
among others: the results of preclinical and clinical trials related to
Phenoptin and Phenylase, both for the treatment of PKU and for indications other
than PKU; results and timing of current and planned clinical trials of Phenoptin
for the treatment of PKU; the content and timing of decisions by the U.S. Food
and Drug Administration, the European Medicines Agency and other regulatory
authorities concerning Phenoptin and Phenylase; the ability to develop suitable
formulations of Phenylase; the ability to develop commercial scale manufacturing
for Phenoptin and Phenylase; and those factors detailed in BioMarin's filings
with the Securities and Exchange Commission, including, without limitation, the
factors contained under the caption "Factors That May Affect Future Results" in
BioMarin's 2004 Annual Report on Form 10-K and the factors contained in
BioMarin's reports on Forms 10-Q and 8-K. Stockholders are urged not to place
undue reliance on forward-looking statements, which speak only as of the date
hereof. BioMarin is under no obligation, and expressly disclaims any obligation,
to update or alter any forward
FOR 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.
2/3
#####
Aldurazyme(R) is a registered trademark of BioMarin/Genzyme LLC.
Orapred(R) is a registered trademark of Medicis Pediatrics, Inc., and is used
under license.
CONTACTS:
FOR BIOMARIN:
Investors Media
Joshua A. Grass Susan Ferris
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 506-6777 (415) 506-6701
http://www.bmrn.com
FOR 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
------------------------
3/3
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 16, 2005 By: /s/ Stuart Grant
------------------------------
Name: Stuart Grant
Title: Chief Financial Officer