Biogen Idec and Biovitrum Announce Decision to Advance Long-Acting Hemophilia B Therapy into a Registrational Trial

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Mon Oct 19, 2009 2:30am EDT

CAMBRIDGE, Mass. & STOCKHOLM--(Business Wire)--
Biogen Idec (NASDAQ: BIIB) and Biovitrum AB (STO: BVT) today announced that they
plan to advance the companies` long-acting, fully-recombinant Factor IX Fc
fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B
patients. The decision to advance the program is based on promising data from a
Phase I/IIa open-label, multi-center, safety dose-escalation and pharmacokinetic
study of intravenous rFIXFc in severe, previously-treated hemophilia B patients.
rFIXFc was well tolerated in the study. In addition, rFIXFc demonstrated a
prolonged half-life compared to historical data for existing therapies,
supporting advancement of the program. 

Hemophilia B requires frequent injections, creating a significant burden for the
majority of individuals with the disorder. The potential of rFIXFc, which is
based on Biogen Idec's novel and proprietary monomeric Fc-fusion technology, to
prolong protection from bleeding and reduce the frequency of injections for both
prophylaxis and on-demand therapy will be evaluated in the registrational trial.


The global trial is being designed to assess the safety, pharmacokinetics and
efficacy of rFIXFc in the prevention and treatment of bleeding in hemophilia B
patients. The trial will commence following communications with regulatory
authorities. rFIXFc has received orphan medicinal product designation for the
treatment of hemophilia B from both the European (EMEA) and US (FDA)
authorities. 

"rFIXFc is an example of Biogen Idec`s commitment to developing innovative
therapies to address significant unmet medical needs. The rFIXFc program has the
potential to improve the lives of individuals with hemophilia B and we are
excited about advancing the program," said Glenn Pierce, Vice President and
Chief Medical Officer of Biogen Idec`s hemophilia therapeutic area. 

"The Phase I/II results are very encouraging. The decision to initiate our first
registrational program represents true progress in our efforts to offer
hemophilia B patients treatment that makes a significant difference and is also
an important milestone in the ongoing development of Biovitrum," said Martin
Nicklasson, CEO of Biovitrum. 

About Hemophilia

Hemophilia is a rare, inherited disorder in which the ability of a person`s
blood to clot is impaired. Hemophilia B occurs in about 1 in 25,000 male births
annually and is caused by having substantially reduced or no factor IX protein,
which is needed for normal blood clotting. People with hemophilia B therefore
need injections of factor IX to restore the coagulation process and prevent
frequent bleeds that could otherwise lead to pain, irreversible joint damage and
life-threatening hemorrhages. Prophylaxis treatment with infusions two or three
times per week to maintain a sufficient circulating level of coagulation factor
is being increasingly used, and long-term studies demonstrate that such regimens
increase the patient`s life expectancy and greatly reduce if not eliminate
progressive joint deterioration. 

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet
medical needs. Biogen Idec is a global leader in the discovery, development,
manufacturing, and commercialization of innovative therapies. Patients in more
than 90 countries benefit from Biogen Idec's significant products that address
diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For
product labeling, press releases and additional information about the company,
please visit www.biogenidec.com. 

About Biovitrum

Biovitrum is an international pharmaceutical company that markets specialist
pharmaceuticals in several regions globally. The company head office is located
in Sweden. Using its expertise and experience Biovitrum takes scientific
innovation to patients with significant medical need. Research expertise and
capabilities are focused on development and production of biotechnology
therapeutics within our prioritized areas of hemophilia, inflammation/autoimmune
diseases and malabsorption. The company has revenues of approximately SEK 1.2
billion and around 400 employees. It is listed on the OMX Nordic Exchange in
Stockholm. For more information go to www.biovitrum.com.

Safe Harbor

This press release contains forward-looking statements regarding the development
of long-acting, recombinant Factor IX Fc fusion as a potential treatment for
hemophilia B. These statements are based on the companies` current beliefs and
expectation. 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 we may not fully enroll our planned clinical
trials, unexpected concerns may arise from additional data or analysis,
regulatory authorities may require additional information, further studies, or
may fail to approve the drug, or the companies 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 filed with the Securities and Exchange Commission. The
companies assume no obligation to update any forward-looking statements, whether
as a result of new information, future events or otherwise. 

Biovitrum AB (publ) may be required to disclose the information provided herein
pursuant to the Swedish Securities Markets Act. The information was provided for
public release on October 19, 2009 at 08:30 a.m. CET.

Biogen Idec Media Contact:
Tracy Vineis, 617-914-6524
Senior Manager, Public Affairs
or
Biogen Idec Investor Relations Contact:
Eric Hoffman, 617-679-2812
Director, Investor Relations
or
Biovitrum AB (publ)
Erik Kinnman, +46 73 422 15 40
Vice President Investor Relations
erik.kinnman@biovitrum.com
or
Martin Nicklasson, +46 8 697 20 00
CEO
martin.nicklasson@biovitrum.com



Copyright Business Wire 2009

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