Biovitrum and Syntonix set to begin phase I/IIa clinical trial of long-acting recombinant Factor IXFc for the treatment of Hemophilia B

Biovitrum AB (publ), Sweden, and Syntonix Pharmaceuticals, Inc., USA,
have obtained approval from the US Food and Drug Administration to
commence a clinical phase I/IIa study of a long-acting, recombinant
Factor IXFc for the treatment of Hemophilia B.

The US Food and Drug Administration (FDA) has approved the initiation
of a phase I/IIa safety and pharmacokinetic study of intravenous,
long-acting, recombinant Factor IX (FIXFc) in previously treated
hemophilia B patients. This first in human study aims to evaluate the
safety and tolerability of FIXFc together with its pharmacokinetic
profile (primarily its plasma half-life) after a single injection of
six different doses. The study will be performed at two clinics in
the United States.

There is an increasing trend toward use of Factor IX for prophylaxis
treatment of Hemophilia B, which requires several infusions per week
with the currently available drugs. The extended half-life of this
new FIXFc product could enable effective treatment for both
prophylaxis and on-demand therapy with less frequent intravenous
injections and thereby provide a new, improved therapy for the
patients. The total market potential for Factor IX products is
estimated to be in excess of USD 600 million worldwide, per year."Hemophilia is a prioritized therapeutic and business area within
Biovitrum.  We are excited to develop FIXFc with Syntonix because we
believe that the company's' SynFusionTM technology has resulted in a
very promising, long-acting recombinant Factor IX product opportunity
that has the potential to reduce the frequency of infusions required
for Hemophilia B patients to manage their disease. The program fits
well with Biovitrum's long experience and broad knowledge within the
area of protein therapeutics and matches perfectly our focus on
specialist indications." said Martin Nicklasson, CEO of Biovitrum.


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 Biovitrum
Biovitrum is a pharmaceutical company with operations in Sweden and
in the UK. Biovitrum has currently a research portfolio with several
projects in clinical and preclinical phases for a number of well
defined specialist indications as well as for common diseases within
obesity, diabetes, inflammation and eye diseases. Biovitrum develops
and produces protein-based drugs on a contractual basis and markets a
range of specialist pharmaceuticals primarily in the Nordic
countries. 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 since September 15, 2006. 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 further information, contact:
Biovitrum AB (publ)

Martin Nicklasson, CEO
Phone. +46 8 697 20 00
martin.nicklasson@biovitrum.com

Göran Arvidson, CFO
Phone: +46 8 697 2368, Mobile: +46 70 633 30 42
goran.arvidson@biovitrum.com

Erik Walum, Director, Science Communication
Phone. +46 8 697 32 40, Mobile: +46 70 312 90 75
erik.walum@biovitrum.com