Company Plans to Request Special Protocol Assessment for Phase 3 Trial
REDWOOD CITY, CA, USA | August 3, 2009 | Facet Biotech Corporation (NASDAQ:FACT – News) today announced its decision, along with its partner Biogen Idec, to continue planning for the phase 3 trial of daclizumab high-yield process (DAC HYP) in multiple sclerosis (MS). The company plans to request a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) prior to the initiation of this study. The companies expect to start the phase 3 trial during the first half of 2010.
"We look forward to working with Biogen Idec to advance the DAC HYP program," said Faheem Hasnain, president and CEO of Facet Biotech. "We believe that DAC HYP could be an important treatment option for MS. Despite advances in MS treatment, there remains a significant need for additional therapies in this patient population."
The companies continue to enroll patients in the SELECT phase 2b monotherapy study of DAC HYP in MS as they plan for the phase 3 study. The independent Safety Monitoring Committee (SMC) for the SELECT study conducted a planned interim futility analysis of a subset of the data and, based on that analysis, the SMC recommended the continuation of the SELECT trial. SELECT remains a blinded study.
Additional details about the phase 3 study will be available prior to the start of the trial. Upon enrollment of the first patient into the phase 3 study, Facet would receive a $30 million milestone payment from Biogen Idec.
SELECT is a phase 2b, randomized, placebo-controlled, dose-ranging study of DAC HYP as a monotherapy treatment in patients with relapsing-remitting MS. Approximately 600 patients will be randomized to receive 150 mg DAC HYP, 300 mg DAC HYP or placebo every four weeks as a subcutaneous injection. The primary endpoint is reduction in the annualized relapse rate. Secondary endpoints include reductions of new or enlarged gadolinium-enhanced magnetic resonance imaging lesions. SELECT is considered to be the first of two registration-enabling trials required by regulatory authorities.
Under the terms of the collaboration agreement between Facet and Biogen Idec, in the U.S. and Europe, the two companies equally share the costs of all development activities and, if any of the products are commercialized, all operating profits. Each party will have co-promotion rights in the U.S. and Europe, based upon sales capabilities of each party at the time. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to Facet. Facet also is eligible for future development and regulatory milestones based on the further successful development of daclizumab.
About Daclizumab
Daclizumab is a humanized monoclonal antibody that binds to the high affinity IL-2 receptor and selectively inhibits this receptor on activated T cells. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax under a license from Facet Biotech. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. For clinical development in chronic diseases, Facet has developed a high-yield manufacturing process for daclizumab (DAC HYP), which includes a high concentration, liquid formulation for subcutaneous delivery. DAC HYP is an investigational agent in clinical development for the treatment of MS under a collaboration between Facet and Biogen Idec. Daclizumab is not approved for the treatment of MS.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately two million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
About Facet Biotech
Facet Biotech is a biotechnology company dedicated to advancing its pipeline of four clinical-stage products, leveraging its research and development capabilities to identify and develop new oncology drugs and applying its proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics. Facet Biotech Corporation launched in December 2008 as a spin-off from PDL BioPharma, Inc.
SOURCE: Facet Biotech Corporation
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Company Plans to Request Special Protocol Assessment for Phase 3 Trial
REDWOOD CITY, CA, USA | August 3, 2009 | Facet Biotech Corporation (NASDAQ:FACT – News) today announced its decision, along with its partner Biogen Idec, to continue planning for the phase 3 trial of daclizumab high-yield process (DAC HYP) in multiple sclerosis (MS). The company plans to request a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) prior to the initiation of this study. The companies expect to start the phase 3 trial during the first half of 2010.
"We look forward to working with Biogen Idec to advance the DAC HYP program," said Faheem Hasnain, president and CEO of Facet Biotech. "We believe that DAC HYP could be an important treatment option for MS. Despite advances in MS treatment, there remains a significant need for additional therapies in this patient population."
The companies continue to enroll patients in the SELECT phase 2b monotherapy study of DAC HYP in MS as they plan for the phase 3 study. The independent Safety Monitoring Committee (SMC) for the SELECT study conducted a planned interim futility analysis of a subset of the data and, based on that analysis, the SMC recommended the continuation of the SELECT trial. SELECT remains a blinded study.
Additional details about the phase 3 study will be available prior to the start of the trial. Upon enrollment of the first patient into the phase 3 study, Facet would receive a $30 million milestone payment from Biogen Idec.
SELECT is a phase 2b, randomized, placebo-controlled, dose-ranging study of DAC HYP as a monotherapy treatment in patients with relapsing-remitting MS. Approximately 600 patients will be randomized to receive 150 mg DAC HYP, 300 mg DAC HYP or placebo every four weeks as a subcutaneous injection. The primary endpoint is reduction in the annualized relapse rate. Secondary endpoints include reductions of new or enlarged gadolinium-enhanced magnetic resonance imaging lesions. SELECT is considered to be the first of two registration-enabling trials required by regulatory authorities.
Under the terms of the collaboration agreement between Facet and Biogen Idec, in the U.S. and Europe, the two companies equally share the costs of all development activities and, if any of the products are commercialized, all operating profits. Each party will have co-promotion rights in the U.S. and Europe, based upon sales capabilities of each party at the time. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to Facet. Facet also is eligible for future development and regulatory milestones based on the further successful development of daclizumab.
About Daclizumab
Daclizumab is a humanized monoclonal antibody that binds to the high affinity IL-2 receptor and selectively inhibits this receptor on activated T cells. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax under a license from Facet Biotech. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. For clinical development in chronic diseases, Facet has developed a high-yield manufacturing process for daclizumab (DAC HYP), which includes a high concentration, liquid formulation for subcutaneous delivery. DAC HYP is an investigational agent in clinical development for the treatment of MS under a collaboration between Facet and Biogen Idec. Daclizumab is not approved for the treatment of MS.
About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately two million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.
About Facet Biotech
Facet Biotech is a biotechnology company dedicated to advancing its pipeline of four clinical-stage products, leveraging its research and development capabilities to identify and develop new oncology drugs and applying its proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics. Facet Biotech Corporation launched in December 2008 as a spin-off from PDL BioPharma, Inc.
SOURCE: Facet Biotech Corporation
Post Views: 67
