STOCKHOLM, SWEDEN--(Marketwire - December 30, 2010) -
Swedish Orphan Biovitrum (STO: SOBI)
today announced that it has returned full development rights to Symphogen,
developer of Sym001, for ITP (Immune Thrombocytopenic Purpura) treatment
for HDN (Hemolytic Disease in Newborn) prophylaxis, for strategic reasons.
Sym001 is currently in clinical phase II for treatment of ITP and in ADP
Prophylaxis) to prevent HDN. The Sym001 program is based on Symphogen's
recombinant polyclonal technology and has been jointly developed since
from early preclinical to its current clinical phase. Swedish Orphan
(Sobi) has now decided to opt out of the program to be able to focus fully
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
stage development portfolio", said Peter Edman, CSO of Sobi.
Rozrolimupab (Sym001) is a recombinant polyclonal composition of 25
Rhesus D specific antibodies for the treatment of primary Immune
Thrombocytopenia (formerly designated Idiopathic Thrombocytopenic Purpura)
and for Anti-RhD prophylaxis (ADP) in prevention of Hemolytic Disease of
Newborn. In February 2008, Symphogen and Sobi reported results from a Phase
dose-escalation, placebo-controlled trial, demonstrating that Sym001 was
and well tolerated. In November 2008 Symphogen and Sobi reported the
a clinical study which demonstrated proof of concept in healthy volunteers.
results showed that Sym001 cleared the RhD-positive red blood cells and
clearance was dose dependent. The ongoing phase II clinical trial evaluates
safety and efficacy, and explores the dose range of Sym001 in immune
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
and approximately 500 employees. The head office is located in Sweden and
share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information
Swedish Orphan Biovitrum may be required to disclose the information
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on December 30, 2010, 08.30 a.m. CET.
Press release December 30 in PDF format :
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE