Print This Story  Email This Story  Save this Link View PR Newswire's RSS Feed  Blogs Discussing this News Release  Search Blogs that Mention this News Release  Click this link to view linked Bookmarking Services Click this link to view linked Blogging Services


Serono and Syntonix to Pursue the Development of a Long-Acting, Inhaleable FSH Therapy to Treat Infertility

    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.


SOURCE Serono International S A




Back to Topback to top

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, kwatson@macbiocom.com; Corporate and Investor
Relations: John Ripple, Chief Executive Officer, Tel:
+1-781-547-5288, http://www.syntnx.com