Serono and Syntonix to Pursue the Development of a Long-Acting, Inhaleable FSH Therapy to Treat Infertility
September 18 2006 - 2:00AM
PR Newswire (US)
GENEVA, Switzerland and WALTHAM, Massachusetts, September 18
/PRNewswire-FirstCall/ -- - Second Agreement Between Companies
Builds on Interferon-beta SynFusion(TM) Program Serono (virt-x: SEO
and NYSE: SRA) and Syntonix Pharmaceuticals Inc. announced today
that they have entered into an agreement under which the companies
will evaluate Syntonix' FSH:Fc SynFusion(TM) products for further
development. Syntonix' SynFusion and Transceptor(TM) technologies
may enable the development of a long-acting FSH therapy for the
treatment of infertility that can be inhaled and dosed less
frequently, instead of injected daily. Under the terms of the
agreement, Syntonix has provided Serono with an exclusive option to
license exclusive, worldwide rights for the development and
commercialization of Syntonix' FSH:Fc SynFusion drugs. Serono will
decide whether to exercise the option after further evaluation of
the FSH:Fc candidates. Serono will pay Syntonix a collaboration and
option fee. If Serono exercises the option, Syntonix will receive
an additional upfront license fee and will be eligible for
milestone fees (total fees worth up to $54 million) as well as
royalties upon commercialization. Additional financial terms were
not disclosed. Serono is the world leader in the treatment of
infertility and currently markets GONAL-f(R) (follitropin alfa), a
highly consistent recombinant human follicle-stimulating hormone
(r-hFSH). GONAL-f(R) has been approved in over 90 countries
worldwide including Europe and the US with indications of
stimulation of the growth of ovarian follicles and ovulation in
women. It is the most widely prescribed gonadotropin in the world.
"Serono is the only company to offer a comprehensive portfolio of
state-of-the-art fertility medications for every stage of the
treatment process for both men and women, and we are constantly
investigating new therapies and improvements to current options,"
said Steve Arkinstall, Head of the Serono Research Institute in
Rockland, MA, headquarters of Serono's Reproductive Health
research. "We have been pleased with our collaboration with
Syntonix for the development of interferon-beta:Fc SynFusion
products and we are excited about the potential to provide patients
with a more convenient way to administer FSH therapy in the
future." "Serono's leading position in the fertility market
combined with its global leadership in biotechnology make them an
important partner for Syntonix," stated John Ripple, CEO of
Syntonix. "We look forward to expanding our relationship with
Serono with this new opportunity to extend its highly successful
product franchise in the field of reproductive health. This second
collaboration with Serono and fifth corporate partnership validates
the broad application of Syntonix' technologies." About Syntonix'
SynFusion(TM) and Tranceptor(TM) Technologies Syntonix' SynFusion
technology links the Fc region of an antibody to a drug in a novel
manner, resulting in long-acting therapeutic proteins or peptides
that can be dosed less frequently. Syntonix' Transceptor technology
uses the FcRn transport pathway to enable the pulmonary delivery of
its novel SynFusion drugs with high systemic bioavailability.
Syntonix' pulmonary drug formulations allow patients to breath
normally using existing marketed inhaler devices. The Role of Human
Follicle Stimulating Hormone in the Body Human follicle stimulating
hormone (FSH) is responsible for the development of follicles in
the ovaries, an essential step in the development of mature oocytes
(eggs), capable of being fertilized. It is also necessary for the
production of healthy spermatozoa in men. Low or lack of secretion
of human FSH is a major cause of infertility. Serono's
forward-looking statement 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 February 28, 2006. 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 any
government investigations and litigation. Serono is providing this
information as of the date of this press release, and 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 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 and
autoimmune diseases. In 2005, Serono, whose products are sold in
over 90 countries, achieved worldwide revenues of US$2,586.4
million. Reported net loss in 2005 was US$106.1 million, reflecting
a charge of US$725 million taken relating to the settlement of the
US Attorney's Office investigation of Serostim. Excluding this
charge as well as other non-recurring items, adjusted net income
grew 28.4% to US$565.3 million in 2005. 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). http://www.serono.com/ http://www.seronousa.com/
About Syntonix Syntonix is developing next generation
biopharmaceuticals that enable better treatment options for
patients with devastating chronic diseases such as hemophilia,
anemia, multiple sclerosis, and autoimmune disorders. The company
applies its core technologies to develop long-acting SynFusion(TM)
drugs that may be inhaled or injected less frequently, and to
discover novel SynTagonist(TM) drugs to treat antibody-mediated
autoimmune and inflammatory disorders. The resulting proteins,
peptides and antibodies are being commercialized through internal
development programs and collaborations with biotechnology and
pharmaceutical partners. Syntonix' lead product is a long-acting
Factor IX product for the treatment of Hemophilia B, which is being
developed in a strategic alliance with Biovitrum AB of Sweden. Upon
approval, Syntonix will market the product in North America. More
information is available at http://www.syntnx.com/. DATASOURCE:
Serono International S A CONTACT: For more information, please
contact: 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, Reuters: SEO.VX / SRA,
Bloomberg: SEO VX / SRA US; Investor Relations, USA: Tel:
+1-781-681-2552, Fax: +1-781-681-2912; Syntonix: Media Relations:
Kari Watson, MacDougall Biomedical Communications, Tel:
+1-508-647-0209, ; Corporate and Investor Relations: John Ripple,
Chief Executive Officer, Tel: +1-781-547-5288,
http://www.syntnx.com/
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