Symphogen and Swedish Orphan Biovitrum receive U.S. orphan drug designation for Rozrolimupab in ITP


Copenhagen, Denmark and Stockholm, Sweden - October 6, 2010 - Symphogen and
Swedish Orphan Biovitrum (STO:SOBI)  today announced that the United States Food
and Drug Administration (FDA) has granted orphan drug designation to
rozrolimupab (Sym001) for the treatment of primary Immune Thrombocytopenia
(ITP).

An FDA Orphan Drug designation provides tax benefits and an exemption from user
fees, eligibility for grant funding, the opportunity of protocol assistance, the
possibility to receive a fast track and expedited review process, as well as a
seven-year period of market exclusivity after product approval.

ITP is an autoimmune bleeding disorder characterized by abnormally low platelet
levels, making it difficult for the blood to clot normally.

"Orphan drug designation provides us with valuable regulatory support for the
development of Sym001 in ITP that will be beneficial in our ambition to develop
this innovative treatment for chronic ITP patients and provide an alternative
treatment to them," says Peter Edman, Chief Scientific Officer, Swedish Orphan
Biovitrum.

"Sym001 is the first ever recombinant polyclonal antibody product to have
entered human clinical trials," stated Kirsten Drejer, PhD., Chief Executive
Officer of Symphogen. "Sym001 is currently being studied in a Phase II dose
finding trial. We intend to develop it as an alternative to plasma derived anti
D and immunoglobulins".

About primary immune thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (previously called Idiopathic Thrombocytopenic
Purpura) (ITP) is a rare, chronic and debilitating autoimmune disorder
associated with increased bleeding risk and impaired quality of life. The
primary cause of long-term morbidity and mortality in patients with ITP is
hemorrhage(1). The prevalence of ITP in the United States is estimated to be
34,200.
(1)Danese MD et al. Cost and mortality associated with hospitalizations in
patients with immune thrombocytopenic purpura. Am J Hematol. Jul 16 2009.

About Sym001
Rozrolimupab (Sym001) is a recombinant polyclonal composition of 25 different
Rhesus D specific antibodies for the treatment of primary Immune
Thrombocytopenia (formerly designated Idiopathic Thrombocytopenic Purpura) (ITP)
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 November 2008 Symphogen and Biovitrum reported the
results of a clinical study which demonstrated proof of concept in healthy
volunteers. The results showed that Sym001 cleared the RhD-positive red blood
cells and that the clearance was dose dependent. The ongoing phase II clinical
trial evaluates the safety and efficacy, and explores the dose range of Sym001
in immune thrombocytopenia patients.

About Symphogen
Symphogen is developing superior antibody therapeutics (monoclonal, monoclonal
mixtures and polyclonal) to help people with serious diseases and significant
unmet medical needs. With its proprietary, unique Symplex(TM) discovery and
Sympress(TM) manufacturing platforms, the company captures the diversity and
specificity of the natural immune response in rationally designed recombinant
antibody compositions. Symphogen is maturing a diversified pipeline of internal
and partnered products across multiple indications including cancer, autoimmune
and infectious disease. Symphogen is a private biopharmaceutical company
headquartered in Copenhagen, Denmark, with a US subsidiary in Princeton, New
Jersey.

About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum 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 pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer
supportive care and inherited metabolic disorders. Swedish Orphan Biovitrum had
pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The
head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ
OMX Stockholm. For more information please visitwww.sobi.com.

For more information please contact:
Symphogen A/S
Kirsten Drejer, Chief Executive Officer
Phone: +45 45 26 50 59 (office) or +45 22 10 99 59 (cell)
E-mail:kd@symphogen.com

Jørgen Petersen, Chief Development Officer
Phone: +45 45 26 50 71 (office) or +45 21 37 19 16 (cell)
E-mail:jpe@symphogen.com

Swedish Orphan Biovitrum AB (publ):
Peter Edman, Chief Scientific Officer
Phone. +46 8 697 21 77
E-mail:peter.edman@sobi.com

Erik Kinnman, Vice President Investor Relations
Phone: +46 73 422 15 40
E-mail:erik.kinnman@sobi.com

Swedish Orphan Biovitrum 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 6, 2010 at 8:30 a.m. CET.



[HUG#1449351]


Attachments

Press release in PDF format.pdf