Swedish Orphan Biovitrum returns development rights to Sym001 to Symphogen
Stockholm, Sweden - December 30, 2010 - Swedish Orphan Biovitrum (STO:SOBI)
today announced that it has returned full development rights to Symphogen, co-
developer of Sym001, for ITP (Immune Thrombocytopenic Purpura) treatment and
for HDN (Hemolytic Disease in Newborn) prophylaxis, for strategic reasons.
Sym001 is currently in clinical phase II for treatment of ITP and in ADP (anti-D
Prophylaxis) to prevent HDN. The Sym001 program is based on Symphogen's
recombinant polyclonal technology and has been jointly developed since 2006,
from early preclinical to its current clinical phase. Swedish Orphan Biovitrum
(Sobi) has now decided to opt out of the program to be able to focus fully on
its late-stage development pipeline.
"We have appreciated the collaboration with Symphogen on this novel program
which may offer patients significant value in the future. With a maturing
pipeline we have, however, been forced to prioritize the delivery of our late
stage development portfolio", said Peter Edman, CSO of Sobi.
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 Sobi reported results from a Phase I
dose-escalation, placebo-controlled trial, demonstrating that Sym001 was safe
and well tolerated. In November 2008 Symphogen and Sobi 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 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
Peter Edman, CSO
Phone. +46 8 697 21 77
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 December 30, 2010, 08.30 a.m. CET.