Biovitrum and Symphogen Initiates a Second Clinical study with a Novel Treatment of Hemolytic Diseases



STOCKHOLM, Sweden  and  COPENHAGEN,  Denmark -  Biovitrum  AB  (publ)
(Ticker: STO:BVT) and Symphogen A/S today announced the initiation of
a clinical proof  of mechanism  study to demonstrate  the ability  of
Sym001 (RhD  polyclonal antibody)  to  clear RhD-positive  red  blood
cells  from  the  circulation  of  RhD-negative  healthy  volunteers.
Clearance of  red  blood cells  by  RhD antibodies  is  an  important
treatment in preventing  hemolytic disease  in RhD-positive  newborns
with RhD-negative mothers.

Sym001 is a  new class  of biopharmaceuticals for  the prevention  of
hemolytic disease of the newborn by anti-D prophylaxis (ADP), and for
the treatment of Idiopathic Thrombocytopenic Purpura (ITP)."Sym001 is an exciting development candidate that represents a novel
and attractive therapeutic option for ADP and ITP. The present  study
will further contribute to the advancement of our project  portfolio,
which presently includes nine  clinical projects. The Sym001  project
fits well with Biovitrum's long experience and broad knowledge within
the protein  therapeutic  area  and is  perfectly  aligned  with  our
specialist care  products  focus",  said Martin  Nicklasson,  CEO  of
Biovitrum."Sym001 is the first ever recombinant polyclonal antibody product  to
have entered human clinical trials and this red blood cell  challenge
study is an  important step  in the further  development of  Sym001",
said  Kirsten  Drejer,  CEO   of  Symphogen.  "Symphogen's   antibody
technology platform offers the  opportunity to generate  compositions
of recombinant  polyclonal antibodies  as well  as single  monoclonal
antibodies which opens an exciting avenue for development of antibody
therapeutics addressing unmet medical needs."

This novel treatment  does not  carry with  it the  risks of  current
immunoglobulin  therapies  related  to  their  blood  donor   origin.
Symphogen  and  Biovitrum  are  jointly  developing  Sym001  under  a
co-development and commercialization  agreement. A  phase 1  clinical
study completed in February 2008 showed that Sym001 is safe and  well
tolerated in healthy volunteers.
For further information please contact:

Symphogen A/S
Kirsten Drejer, CEO
Phone: +45 45 26 50 59, Mobile: +45 22 10 99 59
kd@symphogen.com

Christian Meyer, Vice President, Clinical Research, Medical and
regulatory affairs
Phone: +45 45 26 63 70, Mobile: +45 26 16 53 70
cme@symphogen.com


Biovitrum AB (publ)
Martin Nicklasson, CEO
Phone: +46 8 697 20 00
martin.nicklasson@biovitrum.com

Erik Kinnman, Vice President, Investor Relations & Public Affairs
Phone: +46 73 422 15 40
erik.kinnman@biovitrum.com




To the Editor:

About the Sym001 red blood cell challenge study
The  trial  will  be  a  dose-adjusting,  partly  double-blind1   and
randomized2 study. Sym001 will be  compared with an active  control3.
The primary objective is to study the ability of Sym001 to clean  out
RhD-positive red  blood cells,  following an  RhD-positive red  blood
cell challenge4  to  RhD-negative healthy  subjects  as a  model  for
Anti-D prophylaxis. The study is divided  into two parts:  1) In  the
first part Sym001 or control will be administered intravenously to  a
maximum  of  36  healthy  male  subjects.  2)  In  the  second   part
administration will  be  done  intramuscularly to  a  maximum  of  30
healthy male subjects. The trial is conducted at a clinic in  Germany
and interim results are expected at the end of 2008.
1Neither individuals nor researchers know who belongs to the  control
group and  the experimental  group  during the  active phase  of  the
trial.
2Volunteers are divided between experimental and control groups at
random.
3Results will be compared with individuals treated with an active
agent with the desired effect on RhD-positive red blood cells.
4Administration of RhD-positive red blood cells aimed at provoking an
immune response, i.e. generation of anti-D antibodies.

About Rh-immunization and Idiopathic Thrombocytopenic Purpura
Hemolytic disease of  the newborn occurs  when an RhD-negative  woman
becomes sensitized to RhD when carrying an RhD-positive fetus.   This
immune  reaction  can  trigger   a  maternal  antibody  response   in
subsequent RhD-positive pregnancies, causing  the breakdown of  fetal
red blood cells, i. e. hemolytic disease.

Idiopathic  Thrombocytopenic   Purpura   is   a   bleeding   disorder
characterized  by  an  autoimmune  reaction  induced  abnormally  low
platelet level, making it difficult for the blood to clot.

About Sym001
Sym001 is a recombinant polyclonal composition of 25 different Rhesus
D antibodies  for anti-RhD  prevention of  hemolytic disease  of  the
newborn and for the treatment of Idiopathic Thrombocytopenic Purpura.
Preclinical studies  of Sym001  demonstrated  a binding  potency  and
biological  function  similar  to  existing  plasma-derived  anti-RhD
products. A phase 1 clinical trial was completed in February 2008 and
the results showed that Sym001 is safe and well tolerated in  healthy
volunteers.

About the Market
Conventional immunoglobulin products are  isolated from the blood  of
donors. They are subject to potential  safety issues due to the  risk
of disease transmission, relatively  low batch to batch  consistency,
as well as to  supply shortages caused by  dependency on donor  blood
availability.    Biovitrum's  and  Symphogen's  recombinant     human
 product Sym001 can be  produced in unlimited  supply, it carries  no
known risk  of  viral or  prion  transmission and  the  manufacturing
process brings the composition  of antibodies under control,  product
qualities which  the Companies  believe makes  it a  more  attractive
therapeutic option for both ITP and ADP.

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 Symphogen
Symphogen  is  the  leader   in  developing  recombinant   polyclonal
antibodies (pAb), a new class of biopharmaceuticals for the treatment
of serious  human diseases.   By  employing its  pioneering  antibody
discovery  and   manufacturing  technologies,   Symphogen   generates
recombinant antibody  compositions  that capture  the  diversity  and
effectiveness of the natural immune  system. Symphogen is building  a
proprietary product pipeline within several disease areas,  including
infectious   diseases   and   cancer.   Symphogen   has   established
collaborations with international pharmaceutical companies.

Symphogen is a private biopharmaceutical company employing 85 people,
based in Copenhagen, Denmark. Refer to www.symphogen.com for  further
information on Symphogen.

Attachments

Sym001_Full_Release