GENEVA, Switzerland and WALTHAM, Massachusetts, March 31
/PRNewswire-FirstCall/ -- Serono (virt-x: SEO and NYSE: SRA) and Syntonix
Pharmaceuticals Inc. announced today that they have entered into an agreement
under which Serono has licensed worldwide exclusive rights to Syntonix'
Transceptor(TM) and Synfusion(TM) technologies for the development and
commercialization of interferon-beta:Fc products.
    Syntonix' technologies may enable the development of an interferon-beta
therapy for multiple sclerosis (MS) that can be administered by inhalation.
It has been demonstrated that certain Fc constructs can facilitate transport
of therapeutic proteins across the lung epithelium through neonatal Fc
receptor-mediated uptake. In in vivo experiments conducted by Syntonix and
Serono, a proprietary interferon-beta:Fc molecule produced by Syntonix
exhibited pharmacokinetic and pharmacodynamic properties that justify further
development.
    Serono currently markets Rebif(R), a high-dose, high-frequency interferon
beta-1a therapy for relapsing forms of MS, which is administered three times
weekly via subcutaneous injection. Rebif(R) is the leading treatment for MS
outside the US and the fastest growing treatment for MS in the US.
    "Serono has a long-term commitment to people living with multiple
sclerosis, as demonstrated by our continual product enhancements and
educational support services, and we are constantly investigating new
therapies and improvements to current options," said Tim Wells, Head of
Research of Serono. "We believe that interferon-beta:Fc represents a
promising approach to enable delivery of interferon beta-1a by inhalation,
and has the potential to provide an easier way to administer therapy in the
future."
    "Serono's commitment to multiple sclerosis combined with its global
leadership in biotechnology make them an important partner for Syntonix,"
stated Garen Bohlin, President and CEO of Syntonix. "We are pleased that our
Transceptor(TM) and SynFusion(TM) technologies have provided Serono with an
opportunity to extend its already highly successful product franchise in the
multiple sclerosis field."
    Under the terms of the agreement, Serono will be responsible for all
further development and commercialization of the product. Syntonix will
receive an upfront license fee and will be eligible for development
milestones and royalties upon commercialization. Additional financial terms
were not disclosed.
    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 active receptor-dependent uptake of
these drugs. Specifically, this enables the development of longer-acting
protein therapeutics by facilitating the recirculation of proteins through
the FcRn pathway, delaying catabolism (the natural processes through which
the body breaks down proteins) and extending their circulating half-life.
    Syntonix' Transceptor technology uses the FcRn transport pathway to
enable the pulmonary delivery of its novel Fc-fusion drugs. Syntonix'
pulmonary drug formulations work with existing marketed inhaler devices and
do not require changes to Fc fusions that are longer acting injectable drugs.
    About Rebif(R)
    Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the body's
immune system, fight disease and reduce inflammation.
    Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. In the United States,
Rebif(R) is co-marketed by Serono, Inc. and Pfizer Inc. In 2004, Rebif(R)
sales amounted to US$1.1 billion.
    Rebif(R) has been proven to reduce MRI lesion activity and area(1),
reduce the frequency of relapses, and delay the progression of disability.
Rebif(R) is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe
and can be stored at room temperature for up to 30 days if a refrigerator is
not available.
    Most commonly reported side effects are injection site disorders,
flu-like symptoms, elevation of liver enzymes and blood cell abnormalities.
Patients, especially those with depression, seizure disorders, or liver
problems, should discuss treatment with Rebif(R) with their doctors.
    About multiple sclerosis
    Multiple sclerosis is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease in young
adults. Multiple sclerosis may affect approximately two million people
worldwide. While symptoms can vary, the most common symptoms of multiple
sclerosis include blurred vision, numbness or tingling in the limbs and
problems with strength and coordination. The relapsing forms of multiple
sclerosis are the most common.
    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 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,
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 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).
    About Syntonix
    Syntonix is developing next generation biopharmaceuticals that enable
better treatment options for patients with devastating chronic diseases such
as hemophilia, anemia and autoimmune disorders. The company applies its core
expertise around a critical biological pathway to enhance important existing
drugs and to discover novel therapeutics. The resulting proteins, peptides
and antibodies are being commercialized through internal development programs
and collaborations with biotechnology and pharmaceutical partners. More
information is available at http://www.syntnx.com.
    (1) The exact relationship between MRI findings and the clinical status
of patients is unknown.

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