BioMarin And Serono Form Strategic ALLIANCE for the Development and Commercialization of Phenoptin(TM) and Phenylase(TM)
May 16 2005 - 1:30AM
PR Newswire (US)
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 /PRNewswire-FirstCall/ -- 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." 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 http://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. 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.
DATASOURCE: Serono International S.A. CONTACT: Contacts: For
BioMarin: Investors, Joshua A. Grass, BioMarin Pharmaceutical Inc.
+1-(415)-506-6777 http://www.bmrn.com/ Media, Susan Ferris,
BioMarin Pharmaceutical Inc. +1-(415)-506-6701, For Serono:
Corporate Media Relations: Tel: +41-22-739-36-00 Fax:
+41-22-739-30-85 http://www.serono.com/ Media Relations, USA: Tel:
+1-781-681-2340 Fax: +1-781-681-2935 http://www.seronousa.com/
Corporate Investor Relations: Tel: +41-22-739-36-01 Fax:
+41-22-739-30-22 Investor Relations, USA: Tel: +1-781-681-2552 Fax:
+1-781-681-2912
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