Biovitrum and Symphogen Report Positive Clinical Results in Novel Rh-immunization Prevention Project

STOCKHOLM, Sweden  and  COPENHAGEN,  Denmark  -  November  20,  2008.
Biovitrum AB (publ)  (STO:BVT) and Symphogen  A/S have completed  the
first part of a clinical proof of mechanism study of the  recombinant
human polyclonal  antibody product  Sym001 for  future prevention  of
Hemolytic Disease of the Newborn (HDN) that can occur in RhD-negative
mothers carrying a  RhD-positive fetus.  This can lead  to an  immune
reaction causing destruction of the  red blood cells in the  newborn,
which may give rise to severe anemia, jaundice, and even cause  heart
failure and fatality.

This part of  the first  clinical study investigated  the ability  of
Sym001 to clear RhD-positive red  blood cells given intravenously  to
24   RhD-negative   healthy   males.   Positive   control   was   the
plasma-derived  product  Rhophylac®,  given   to  12  subjects.   The
preliminary results demonstrate that the recombinant human polyclonal
antibody product is able  to clear RhD-positive  blood cells at  five
days after dosing in a dose dependent manner.
Biovitrum and Symphogen  are now planning  for the next  step of  the
clinical programme which should lead to a decision to initiate  phase
III studies  in the  intended  label population,  namely  Rh-negative
mothers carrying an Rh-positive fetus"Clearance of RhD-positive red blood  cells from the circulation  is
key for the prevention of  HDN and thereby constitutes a  significant
medical need. It is therefore  with great satisfaction we note  these
positive results which  advances the development  of this  innovative
biotechnology therapy to prevent newborns from developing HDN.", said
Martin Nicklasson, CEO of Biovitrum."Sym001 is  the  first  ever recombinant  human  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  human  polyclonal  antibodies  as  well  as   single
monoclonal antibodies which opens an exciting avenue for  development
of antibody therapeutics addressing unmet medical needs."

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
Mobile: +46 73 422 15 40
erik.kinnman@biovitrum.com


To the Editor:

About the Sym001 red blood cell challenge study
The results show that Sym001 cleared the RhD-positive red blood cells
and that the clearance is dose  dependent. At the highest dose  level
of Sym001 studied (900  µg) the clearance at  five days after  dosing
(primary end-point) was comparable to that of Rhophylac®. Sym001  was
found to be safe and well-tolerated at all doses studied.

The study included 24 subjects at three dose levels of Sym001 and  12
subjects given 300  µg Rhophylac®.  The study  was carried  out at  a
single center in Berlin.

The study was a dose-adjusting, randomized1 and partly  double-blind2
clinical trial.  Sym001 was  compared with  an active  control3.  The
primary objective  was  to  study  the ability  of  Sym001  to  clear
RhD-positive red  blood  cells,  following  their  administration  to
RhD-negative healthy subjects (so-called  RBC challenge4) as a  model
for Anti-D prophylaxis.

The full trial comprises two parts: In the first part (just completed
with  interim  results  presented   above)  Sym001  or  control   was
administered intravenously  to a  36 healthy  male subjects.  In  the
second part administration is planned to be done intramuscularly to a
maximum of 30  healthy male  subjects. The  trial is  conducted at  a
clinic in Germany.

1 Volunteers are divided between experimental and control groups at
random
2 Neither individuals nor researchers know who belongs to the control
group and the experimental group during the active phase of the
trial..
3 Results will be compared with individuals treated with an active
agent with the desired effect on RhD-positive red blood cells.
4 Administration of RhD-positive red blood cells aimed at provoking
an immune response, i.e. generation of anti-D antibodies.

About Anti- D Prophylaxis (ADP) and Hemolytic Disease of the Newborn
(HDN)
HDN 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 in the newborn, i.  e.
hemolytic disease. Anti-D prophylaxis (ADP) means prevention of  such
maternal antibody  response  by  administration  of  anti-D  products
(Rh-immunization)  which  clear  fetus's  RBC  before  they   trigger
sensitization of the maternal immune system.


 About Sym001
This novel intervention 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.

Sym001 is a human recombinant polyclonal composition of 25  different
human IgG1 (Rhesus-D specific) antibodies for anti-RhD prevention  of
Hemolytic Disease  of the  Newborn and  for the  treatment of  Immune
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
polyclonal antibody  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. The company markets a range of specialist  pharmaceuticals
primarily in the Nordic countries. Using its expertise and experience
Biovitrum takes scientific innovation all  the way to the market  and
to specialist  indication  patients with  significant  medical  need.
Research  expertise   and   capabilities  include   development   and
production of biotechnology therapeutics,  as well as small  molecule
discovery and  development. With  revenues of  approximately SEK  1.3
billion and around 500 employees, Biovitrum is a significant European
specialty pharmaceutical player. Biovitrum's  share is listed on  the
OMX  Nordic  Exchange  in  Stockholm.  For  more  information  go  to
www.biovitrum.com

About Symphogen
Symphogen is  the leader  in developing  recombinant  humanpolyclonal
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.