Swedish Orphan Biovitrum agrees with Fresenius Biotech to distribute Removab®

Thursday, 27. January 2011 08:31
Stockholm, Sweden - January 27, 2011 - Swedish Orphan Biovitrum (STO: SOBI)
today announced a Removab(® )distribution agreement with Fresenius Biotech.
Under the agreement Swedish Orphan Biovitrum (Sobi) will distribute Removab(®
)exclusively in 15 European countries over 7 years.

Removab(®) was granted marketing authorization by the European Commission in
April 2009 for the treatment of malignant ascites associated with cancer  and
 has been launched in Germany and Austria so far. The territories in which Sobi
will distribute Removab(®) are Sweden, Denmark, Norway, Finland, Iceland,
Poland, Czech Republic, Slovakia, Slovenia, Romania, Bulgaria, Hungary, Estonia,
Latvia and Lithuania.

"Removab(®) is an innovative product that holds great value to patients with
high medical needs. We are looking forward to the Fresenius Biotech partnership
and the additional growth potential Removab(®) will add to our business.
Moreover, Removab(®) is a perfect fit with our cancer product portfolio such as
Yondelis(®) which is distributed in similar territories," said Kennet Rooth, CEO
of Sobi.

"The agreement with SOBI is part of our strategy of complementing our own
marketing and sales activities with strong partnerships in additional
territories. We appreciate that more patients are now able to benefit from
Removab® ," said Christian Schetter, CEO of Fresenius Biotech.

About Removab(®) (catumaxomab)
Removab® is a registered trade mark by Fresenius Biotech GmbH. It is the first
drug worldwide with a regulatory label for the treatment of malignant ascites.
Removab® is a tri-functional antibody licensed from TRION Pharma GmbH. The
therapeutic objective of Removab® is to generate a strong immune reaction
against cancer cells resulting in their elimination.

The EU approval is based on the results of a large international phase II/III
pivotal study which demonstrated a statistically significant four-fold increase
in puncture-free survival over a therapy with puncture alone. Removab®
effectively destroys cancer cells in the peritoneal cavity and therefore attacks
the primary cause of ascites formation.  This leads to a prolongation to the
time to next paracentesis, a reduction of the number of painful and burdensome
punctures and an improvement of the patients' quality of life and daily
function. In addition, the results of the study indicate a positive impact on
overall survival.

Removab® is approved for the treatment of malignant ascites in patients with
EpCAM (Epithelial Cell Adhesion Molecule) positive carcinomas where standard
therapy is not available or no longer feasible.

EpCAM is a tumor-associated antigen expressed on the vast majority of carcinomas
(epithelial tumors). Furthermore, the vast majority of carcinoma-induced
malignant ascites contain EpCAM positive tumor cells. In healthy tissue, EpCAM
is not accessible to binding, which makes it an attractive antigen for tumor
specific targeting.

About malignant ascites
Malignant ascites is the accumulation of fluid in the abdominal cavity mainly
due to abdominal spread of cancer cells and it is associated with a poor
prognosis. Malignant ascites can be caused by different carcinomas. It is most
common in ovarian, pancreatic and gastric cancers with an incidence of 20 to
50% of all cases. Malignant ascites develops late in the course of the cancer
disease and regularly has a strong impact on the patient's quality of life. The
most commonly used treatment of malignant ascites is puncture (paracentesis),
which has to be carried out repeatedly and can lead to complications such as
infection and fluid or protein deprivation.

About Fresenius and Fresenius Biotech
Fresenius is a health care group with international operations, providing
products and services for dialysis, hospital and outpatient medical care. In
2009, Group sales were approximately €14.2 billion. On Sept. 30, 2010, the
Fresenius Group had 136,458 employees worldwide. For more information visit the
Company's website atwww.fresenius.com.

Fresenius Biotech, a company of the Fresenius health care group, is focused on
the development, marketing and commercialization of biopharmaceuticals in the
fields of oncology and transplantation medicine. Fresenius Biotech is a German
company with headquarters in Munich. For more information please
visitwww.fresenius-biotech.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 pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and
inherited metabolic disorders. Sobi 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:

Swedish Orphan Biovitrum AB (publ)
Erik Kinnman, VP Investor Relations
Phone: +46 73 422 15 40
erik.kinnman@sobi.com


Kennet Rooth, CEO
Phone: +46 8 697 38 82

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 January 27, 2011 at 8:30 a.m. CET.



Press release in pdf format:
http://hugin.info/134557/R/1482798/418117.pdf




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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE

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Author:
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