Swedish Orphan Biovitrum 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.
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 visit www.sobi.com.
SOURCE: Swedish Orphan Biovitrum AB
Post Views: 64
Swedish Orphan Biovitrum 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.
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 visit www.sobi.com.
SOURCE: Swedish Orphan Biovitrum AB
Post Views: 64
