Biogen Idec (NASDAQ: BIIB) and Syntonix Pharmaceuticals today
announced that the companies have signed a definitive agreement for
the acquisition of Syntonix by Biogen Idec. Syntonix, a privately held
biopharmaceutical company focused on discovering and developing
long-acting therapeutic products to improve treatment regimens for
chronic diseases, has multiple pre-clinical programs in hemophilia.
Syntonix uses proprietary technologies to harness the human body's
natural pathways for protecting antibodies against premature
destruction and for transporting antibodies across cell barriers such
as those in the lungs. These technologies may enhance the delivery of
biopharmaceuticals through less frequent injections or by enabling
pulmonary delivery.
Syntonix's lead product, FIX:Fc, is a proprietary long-acting
factor IX product for the treatment of hemophilia B. It has the
potential to reduce the frequency of intravenous injections required
for disease management. Syntonix is expected to file an
investigational new drug application with the Food and Drug
Administration for FIX:Fc in 2007.
"With this transaction, we continue to deliver on our strategic
initiative to enhance our pipeline and expand into additional
specialized markets," said James C. Mullen, Biogen Idec's President
and Chief Executive Officer (CEO). "Syntonix brings promising science
and technology to areas of unmet medical need such as hemophilia, and
we look forward to building on their expertise with Biogen Idec's
global development, manufacturing, and commercial capabilities."
"In pursuing next steps for Syntonix, joining forces with Biogen
Idec was the best option for all stakeholders, including - over the
long-term - patients," said John W. Ripple, CEO of Syntonix. "As a
global leader in biomanufacturing and serving niche markets, Biogen
Idec is well-poised to deliver on the promise of hemophilia therapies
that require less frequent dosing."
The transaction is expected to close in the first quarter of 2007.
Upon completion, Biogen Idec will acquire all of the issued and
outstanding shares of the capital stock of Syntonix for $40 million,
payable at closing, and potential additional payments of up to $80
million upon the achievement of certain development milestones.
Contingent on the closing of the acquisition, Biogen Idec plans to
maintain Syntonix's 25,000 square-foot facility in Waltham, MA for the
continuing operation of Syntonix programs. The transaction, which has
been approved by the boards of directors of both companies, is subject
to customary closing conditions.
About Syntonix's Hemophilia Programs and Technology Platforms
FIX:Fc is being developed for the treatment of hemophilia B in a
strategic alliance with Biovitrum AB of Sweden with the companies
sharing equally the costs and profits of development and
commercialization. After regulatory approval, Syntonix is responsible
for marketing FIX:Fc in North America and Biovitrum is responsible for
marketing FIX:Fc in Europe, Russia, and the Middle East.
Syntonix is pursuing other early-stage programs, including a
long-acting factor VIII program, with the potential to improve the
treatment of hemophilia A. In developing novel and improved
treatments, the company uses propriety technology, including the
SynFusion(TM) and Transceptor(TM) platforms.
SynFusion drugs are based on proprietary Fc-fusion technology to
create long-acting biopharmaceuticals with reduced dosing frequencies.
Specifically, the SynFusion technology links a single copy of the drug
to the Fc region on an antibody to optimize the pharmacokinetic and
pharmacodynamic properties of the biopharmaceutical and extending its
circulating half-life.
Transceptor is a proprietary technology that enables pulmonary
delivery of a SynFusion or Fc-fusion drug. The natural FcRn pathway
transports antibodies and Fc-fusion drugs across the epithelial cell
barrier in the lungs.
About Hemophilia
Hemophilia is a rare, inherited bleeding disorder that is caused
by mutations that impair or eliminate the production of essential
clotting factors naturally found in the blood. Hemophilia B, caused by
mutations in the factor IX gene, affects approximately 3,600 people in
the Unites States. Hemophilia A, caused by mutations in the factor
VIII gene, affects approximately 14,500 people in the U.S. Both forms
of hemophilia are characterized by spontaneous or prolonged bleeding
for which there is no cure.
Today a majority of hemophilia patients are treated with
recombinant-derived factor VIII and IX products. Increasingly, younger
patients are prescribed prophylaxis regimens with these products to
prevent bleeding, rather than receiving treatment at the time of a
bleed ("on-demand"). Long-term studies have demonstrated that
maintaining a better circulating level of coagulation factor by
infusing patients two or three times a week greatly reduces
progressive joint deterioration commonly seen in hemophilia patients
as a result of the bleeding.
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 technologies to develop long-acting SynFusion
drugs that may be inhaled or injected less frequently. 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
www.syntnx.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology
and immunology. As a global leader in the development, manufacturing,
and commercialization of novel therapies, Biogen Idec transforms
scientific discoveries into advances in human healthcare. For product
labeling, press releases and additional information about the company,
please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding
the acquisition of Syntonix Pharmaceuticals and the development of
FIX:Fc. These statements are based on the companies' current beliefs
and expectations. Drug development involves a high degree of risk.
Factors which could cause actual results to differ materially from the
companies' current expectations include: the risk that unexpected
concerns may arise
from additional data or analysis, that regulatory authorities may
require additional information, further studies, or may fail to
approve the drug, or that the company may encounter other unexpected
hurdles. For more detailed information on the risks and uncertainties
associated with Biogen Idec's drug development and other activities,
see the periodic reports of Biogen Idec Inc. filed with the Securities
and Exchange Commission. Biogen Idec assumes no obligation to update
any forward-looking statements, whether as a result of new
information, future events or otherwise.
