WATERTOWN, MA, USA I May 6, 2013 I Enanta Pharmaceuticals, Inc., (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie’s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). ABT-450, Enanta’s lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, is one of three DAAs in the regimen.
The all-oral, triple-DAA combination regimen is currently being studied in Phase 3 clinical trials that are being conducted by AbbVie. The Phase 3 program includes more than 2,000 patients with genotype 1 HCV infection, with trial sites in 29 countries. The DAAs in the trials include ABT-450/r (protease inhibitor and ritonavir) combined with two of AbbVie’s proprietary investigational DAAs, ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor), and are being dosed with and without ribavirin.
According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation include preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.1
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories
In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV protease inhibitor-containing drug combinations. Under the agreement, AbbVie (as the successor to Abbott) is responsible for all development and commercialization activities for ABT-450. Enanta received a $57 million upfront payment upon signing the collaboration agreement, has received all clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales.
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a class of host-targeted antiviral (HTA) inhibitors targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a current focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
SOURCE: Enanta Pharmaceuticals
Post Views: 136
WATERTOWN, MA, USA I May 6, 2013 I Enanta Pharmaceuticals, Inc., (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie’s investigational direct-acting antiviral (DAA) combination regimen with and without ribavirin for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection has been designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). ABT-450, Enanta’s lead HCV protease inhibitor identified in its ongoing collaboration with AbbVie, is one of three DAAs in the regimen.
The all-oral, triple-DAA combination regimen is currently being studied in Phase 3 clinical trials that are being conducted by AbbVie. The Phase 3 program includes more than 2,000 patients with genotype 1 HCV infection, with trial sites in 29 countries. The DAAs in the trials include ABT-450/r (protease inhibitor and ritonavir) combined with two of AbbVie’s proprietary investigational DAAs, ABT-267 (NS5A inhibitor) and ABT-333 (non-nucleoside polymerase inhibitor), and are being dosed with and without ribavirin.
According to the FDA, Breakthrough Therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy designation include preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.1
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories
In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV protease inhibitor-containing drug combinations. Under the agreement, AbbVie (as the successor to Abbott) is responsible for all development and commercialization activities for ABT-450. Enanta received a $57 million upfront payment upon signing the collaboration agreement, has received all clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales.
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a class of host-targeted antiviral (HTA) inhibitors targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a current focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
SOURCE: Enanta Pharmaceuticals
Post Views: 136
