WESTON, MA and STOCKHOLM, SWEDEN--(Marketwire - May 09, 2011) - Biogen Idec (NASDAQ: BIIB)
and Swedish Orphan Biovitrum (STO: SOBI) today announced that the European
Medicines Agency's (EMA) Pediatric Committee (PDCO) has adopted an opinion
agreeing to the pediatric investigational plan for the companies' long-
fully-recombinant Factor IX Fc fusion protein (rFIXFc).
In accordance with the PDCO's opinion, Biogen Idec and Swedish Orphan
plan to initiate a global pediatric trial in
previously-treated patients under
12 years of age as soon as sufficient data are available from a study of
patients. Under draft guidelines published by the EMA for the development
Factor IX products, pediatric data from this trial will be required in the
initial submission of a Marketing Authorization Application to the European
"The EMA's agreement to our pediatric investigational plan is another
in our effort to develop innovative therapies for people with hemophilia,"
Glenn Pierce, M.D., Ph.D., Senior Vice President of Hemophilia at Biogen
"With this opinion and the ongoing Phase 3 trials of our long-lasting
and Factor VIII programs, we continue to make progress toward our goal of
improving the way hemophilia is treated worldwide."
"The opinion from the EMA's Pediatric Committee is valuable for our
rFIXFc project, as it allows for the development of rFIXFc in the pediatric
population. We are excited about the potential of this innovative product
make a difference in the lives of people with hemophilia," said Peter
Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
About rFIXFc and the recombinant Fc Fusion protein hemophilia program
rFIXFc is a recombinant Factor IX Fc fusion protein developed using
fusion technology. The technology makes use of a natural mechanism that
rFIXFc in the circulation to extend its half-life. It is a fully-
clotting factor designed to replace the protein that hemophilia B patients
and to last longer in the body than commercially-available Factor IX
rFIXFc is currently being evaluated in a registrational, open-label,
trial (B-LONG) designed to evaluate its safety, pharmacokinetics and
hemophilia B patients.
Using the same proprietary monomeric Fc fusion technology as rFIXFc, Biogen
and Swedish Orphan Biovitrum are also developing a fully-recombinant, long-
lasting Factor VIII Fc fusion protein (rFVIIIFc) for the treatment of
A. rFVIIIFc is currently being evaluated in a registrational, open-label,
multicenter trial (A-LONG) designed to evaluate its safety,
efficacy in hemophilia A patients. For more information on the rFIXFc and
rFVIIIFc trials, please visit www.biogenidechemophilia.com or
About Hemophilia B
Hemophilia B is a rare, inherited disorder in which the ability of a
blood to clot is impaired. Hemophilia B occurs in about one in 25,000 male
births annually and is caused by having substantially reduced or no Factor
protein, which is needed for normal blood clotting. People with hemophilia
therefore need injections of Factor IX to restore the coagulation process
prevent frequent bleeds that could otherwise lead to pain, irreversible
damage and life-threatening hemorrhages. Prophylactic treatment with
twice per week to maintain a sufficient circulating level of coagulation
is being increasingly used, and long-term studies demonstrate that such
increase the patient's life expectancy and greatly reduce, if not
progressive joint deterioration.
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and
market therapies for serious diseases with a focus on neurology, immunology
hemophilia. Founded in 1978, Biogen Idec is the world's oldest independent
biotechnology company. Patients worldwide benefit from its leading multiple
sclerosis therapies, and the company generates more than $4 billion in
revenues. For product labeling, press releases and additional information
the company, please visit www.biogenidec.com.
About Swedish Orphan Biovitrum (Sobi)
Sobi is a Swedish-based niche specialty pharmaceutical company with an
international market presence. The company is focused on providing and
developing specialist pharmaceuticals for rare disease patients with high
medical needs. The portfolio consists of about 60 marketed products and an
emerging late-stage clinical development pipeline. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and
inherited metabolic disorders. Sobi had pro-forma revenues 2009e of about 2
and approximately 500 employees. The head office is located in Sweden and
share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information
This press release contains forward-looking statements, including
about the development of long-lasting hemophilia therapies. These
be identified by words such as "believe," "expect," "may," "plan," "will"
similar expressions, and 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
trials, unexpected concerns may arise from additional data or analysis,
regulatory authorities may require additional information, further studies,
may fail to approve the drug, or the companies may encounter other
hurdles. For more detailed information on the risks and uncertainties
with Biogen Idec's drug development and other activities, see the periodic
reports of Biogen Idec filed with the Securities and Exchange Commission.
forward-looking statements speak only as of the date of this press release
the companies assume no obligation to update any forward-looking
whether as a result of new information, future events or otherwise.
Swedish Orphan Biovitrum may be required to disclose the information
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on May 9, 2011, 11:15 a.m. CET.
Sobi Press Release May 9, 2011 in PDF format:
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originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE