Serono and Syntonix Sign Worldwide Agreement to Develop and Commercialize an Inhaleable Interferon-Beta Therapy for Multiple Scl
March 31 2005 - 1:00AM
PR Newswire (US)
Serono and Syntonix Sign Worldwide Agreement to Develop and
Commercialize an Inhaleable Interferon-Beta Therapy for Multiple
Sclerosis 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. 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/, Corporate Investor
Relations: Tel: +41-22-739-36-01, Fax: +41-22-739-30-22; Media
Relations, USA: Tel: +1-781-681-2340, Fax: +1-781-681-2935,
http://www.seronousa.com/; Investor Relations, USA: Tel:
+1-781-681-2552, Fax: +1-781-681-2912; Syntonix: Media Relations:
Kari Lampka, MacDougall Biomedical Communications, Tel:
+1-508-647-0209, , Corporate and Investor Relations: Garen Bohlin,
Chief Executive Officer, Tel: +1-781-547-5248,
http://www.syntnx.com/
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