Biovitrum and Syntonix Dose First Hemophilia B Patient in Clinical
Trial of a Novel Factor IXFc Treatment
Stockholm, Sweden and Waltham, MA - May 27, 2008. Biovitrum AB
(STO:BVT) and Syntonix Pharmaceuticals, Inc., a subsidiary of
Biogen/Idec (NASDAQ: BIIB) today announced the initiation of a phase
I/IIa open-label, dose escalation study of a long-acting, recombinant
Factor IXFc (FIXFc) protein in patients with hemophilia B. The study
is ongoing at clinics in the United States and will assess the
safety, tolerability and pharmacokinetics of Factor IXFc in this
patient population.
This FIXFc compound, which pre-clinical studies have shown to have an
extended half-life, could enable effective treatment with less
frequent injections for both prophylaxis and on-demand therapy in
hemophilia B. The current global market for Factor IX products is USD
600 million per year."We are excited about developing FIXFc together with Syntonix since
hemophilia is a prioritized therapeutic and business area within
Biovitrum. In addition, we are developing a recombinant Factor VIIIFc
hemophilia product with Syntonix. Both these programs fit well with
Biovitrum's long experience and broad knowledge within the area of
protein therapeutics and our specialist care business strategy." said
Martin Nicklasson, CEO of Biovitrum."We are pleased to have moved the FIXFc program, which is based on
our SynFusionTM technology, into clinical studies. The purpose of
both the FIXFc and Factor VIIIFc programs is to improve the lives of
hemophilia patients and their families," said Matt Ottmer, General
Manager of Syntonix.
About Hemophilia
Hemophilia is a rare hereditary disorder in which the ability of
patients' blood to clot is impaired. As a result, the patient suffers
from excessive bleeding and uncontrolled internal bleeding, leading
to pain and eventual permanent damage to joints and muscles. One
form, Hemophilia B results from mutations that impair the production
of Factor IX. It has been reported that even with "proper treatment"
the life expectancy of hemophilia patients is about 10 years less
than for individuals without hemophilia. Increasingly, the normal
mode of treatment for younger patients is a prophylaxis regimen where
patients are infused two or three times per week to maintain a better
circulating level of coagulation factor. Long term studies
demonstrate that such regimens greatly reduce if not eliminate
progressive joint deterioration.
About SynFusionTM Technology
The SynFusion technology is based on Syntonix's proprietary Fc-fusion
technologies to create longer-acting biopharmaceuticals. Well-known
and validated traditional Fc-fusion drugs, such as Enbrel®
(etanercept) for the treatment of rheumatoid arthritis, consist of
two copies of a biopharmaceutical linked to the Fc region of an
antibody to improve pharmacokinetics, solubility, and production
efficiency. SynFusion drugs consist of a novel Fc-fusion construct,
called a monomer that links only a single copy of the drug to the Fc
region on an antibody to optimize the pharmacokinetic and
pharmacodynamic properties of the biopharmaceutical when compared to
traditional Fc-fusion constructs
About Biovitrum
Biovitrum is a specialty pharmaceutical company with operations in
Sweden and in the UK. Biovitrum markets a range of specialist
pharmaceuticals primarily in the Nordic countries. The company has a
research portfolio with several projects in clinical and preclinical
phases for a number of well defined specialist indications. Biovitrum
has the expertise and experience to take its projects all the way to
the market. Biovitrum develops and produces protein-based drugs and
also has small molecule research expertise and capabilities.
Biovitrum has revenues of approximately SEK 1.2 billion and around
500 employees. Biovitrum's share is listed on the OMX Nordic Exchange
in Stockholm. For more information see www.biovitrum.com.
About Syntonix
Syntonix Pharmaceuticals, Inc. (Waltham, MA, USA) is a wholly-owned
subsidiary of Biogen Idec. Syntonix is developing next generation
biopharmaceuticals that enable better treatment options for patients
with devastating chronic diseases such as hemophilia and autoimmune
disorders. The company applies its core technologies to develop
long-acting biopharmaceuticals that may be injected less frequently,
and to discover novel 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. More information is available at http://www.syntnx.com/.
For more information please contact:
Biovitrum AB (publ)
Erik Kinnman, Vice President Investor Relations
Phone: +46 73 422 15 40
erik.kinnman@biovitrum.com
Martin Nicklasson, CEO
Phone. +46 8 697 20 00
martin.nicklasson@biovitrum.com