Symphogen and Biovitrum have Initiated a Novel Treatment Study in Autoimmune Bleeding Disorder (ITP) Patients



COPENHAGEN, Denmark and STOCKHOLM, Sweden- July 16, 2008.
 Symphogen A/S and Biovitrum AB (publ) (STO:BVT) today announced  the
recruitment of  the first  patient into  a Phase  II clinical  trial,
initiated in June, to evaluate  the safety and efficacy, and  explore
the dose range of Sym001 in Idiopathic Thrombocytopenic Purpura (ITP)
patients. Sym001 is a recombinant, polyclonal anti-Rhesus D  antibody
product candidate.  Symphogen and  Biovitrum are  jointly  developing
Sym001 under a 50/50  co-development and commercialization  agreement
announced in February 2006."A recombinant  polyclonal Anti-D  product will  provide an  improved
treatment alternative  for  ITP  patients compared  to  the  existing
plasma derived  Anti-D immunoglobulins,  as supplies  of the  current
products are limited and subject to potential safety concerns due  to
their blood  plasma origin.  The initiation  of the  second phase  II
trial with Sym001 this year is  a major step to further validate  the
potential of recombinant polyclonal antibodies as a new class of drug
and to highlight progress in our pipeline." said Kirsten Drejer,  CEO
of Symphogen."The potential  of  Sym001 as  a  new treatment  modality  for  unmet
medical  needs  fits  well  with  Biovitrum's  specialist  care   and
biopharma focus and strengths. Moreover, the initiation of this Phase
II trial is a successful milestone in our working collaboration  with
Symphogen." said Martin Nicklasson, CEO of Biovitrum.

About the Sym001 Phase II Study
Up to 55 RhD-positive adult non-splenectomized patients with ITP will
be enrolled in this first exploratory open label safety, efficacy and
dose-finding trial. The study objective is to evaluate the safety  of
Sym001 following a  single intravenous dose.  In addition, the  study
will determine the  appropriate dose range  in preparation for  Phase
III trials by assessing the  increase in platelet levels and  explore
the mechanism of  action of Sym001  by assessing its  binding to  red
blood cells. Symphogen  is sponsor for  the Phase II  study which  is
being conducted at 23 sites in Europe.

About Sym001
Sym001 is a recombinant polyclonal composition of 25 different Rhesus
D   specific   antibodies   for    the   treatment   of    Idiopathic
Thrombocytopenic  Purpura  and  for  Anti-RhD  prophylaxis  (ADP)  in
prevention of Hemolytic  Disease of  the Newborn.  In February  2008,
Symphogen  and   Biovitrum   reported   results  from   a   Phase   I
dose-escalation, placebo-controlled trial, demonstrating that  Sym001
was safe and  well tolerated.  In April  2008, a  proof of  mechanism
study for ADP was initiated to  demonstrate the ability of Sym001  to
clear  RhD-positive  red   blood  cells  from   the  circulation   of
RhD-negative healthy volunteers.


About Idiopathic Thrombocytopenic Purpura
Idiopathic  Thrombocytopenic  Purpura   is  an  autoimmune   bleeding
disorder characterized by abnormally  low platelet levels, making  it
difficult for  the blood  to  clot normally.  ITP  is a  chronic  and
debilitating disease,  associated with  increased bleeding  risk  and
impaired quality of life.

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  is  a  private  biopharmaceutical  company  with  over  80
employees, based in Copenhagen,  Denmark. Refer to  www.symphogen.com
for further information on Symphogen.

About Biovitrum
Biovitrum is a  specialty pharmaceutical company  with operations  in
Sweden and  in  the  UK.  Biovitrum markets  a  range  of  specialist
pharmaceuticals primarily in the Nordic countries. The company has  a
research portfolio with several projects in clinical and  preclinical
phases for a number of well defined specialist indications. Biovitrum
has the expertise and experience to take its projects all the way  to
the market. Biovitrum develops  and produces protein-based drugs  and
also  has  small  molecule   research  expertise  and   capabilities.
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. For more information see www.biovitrum.com


For more information please contact:

Kirsten Drejer, CEO of Symphogen: +45 45 26 50 59 or +45 22 10 99 59
(cell) kd@symphogen.com

Christian Meyer, Vice President Clinical Research, Medical and
Regulatory Affairs of Symphogen: +45 26 16 53 70 (cell)
cme@symphogen.com

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

Attachments

Full release ITP phase II.pdf