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Novartis Buys Enanta NS5A HCV Drug
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bizjournals: Also, Novartis will fund some other compounds that Enanta is working on that target NS5A.
genengnews: The firm teamed up with Abbott in 2006 to develop and commercialize HCV HS3 and NS3/4A protease inhibitors through a $57 million cash and equity investment deal that also gives its partner access to drug discovery capabilities in the field of HCV NS3 and NS3/4A protease inhibitor field. Enanta's HCV polymerase and cyclophilin programs are ongoing in house.
firecebiotech: Developers at this stage of the game are looking for treatments that have a broad effect across all three genotypes. They also want to find new cocktails that can beat down the virus and eliminate any signs of it without having to resort to interferon. That Holy Grail in R&D is the ticket to a multibillion-dollar market, a prize that has attracted a wide group of biopharma players.
press release
Feb. 21, 2012, 7:01 a.m. EST
Enanta Enters Into Strategic Collaboration to Advance NS5A Inhibitor Candidate for HCV
WATERTOWN, Mass., Feb. 21, 2012 /PRNewswire via COMTEX/ -- Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced today that it has entered into an exclusive collaboration and license agreement with Novartis for the worldwide development, manufacture and commercialization of its lead development candidate, EDP-239, from its NS5A hepatitis C virus (HCV) inhibitor program. Enanta has received IND approval for EDP-239 from the FDA.
NS5A, a clinically validated target, is a non-structural viral protein that is essential to viral replication. Research efforts have shown that targeting NS5A gives rise to profound antiviral activity, and as a result, this protein has emerged as an important target for antiviral drug development. Enanta's NS5A program and intellectual property estate in the HCV field were derived from its internal drug discovery efforts. EDP-239, Enanta's lead candidate targeting NS5A was most recently recognized on Windhover's list of the "Top Most Interesting Infectious Disease Projects to Watch".
Under the terms of the agreement, Enanta will receive an upfront payment of $34 million and is eligible to receive up to $406 million if certain clinical, regulatory, and commercial milestones are met. Enanta is also eligible to receive tiered double-digit royalties on worldwide sales of products, and retains co-detail rights in the United States. Novartis will be responsible for all costs associated with the development, manufacture and commercialization of EDP-239 and will fund Enanta's drug discovery efforts on certain additional compounds targeting NS5A.
"Novartis is a recognized leader in the field of HCV, and access to its global expertise combined with our shared vision for commercializing HCV therapies will support the successful development and commercialization of products targeting NS5A," said Jay R. Luly, PhD, President & CEO, Enanta Pharmaceuticals. "We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans."
About the Hepatitis C VirusHepatitis C is a liver disease affecting over 170 million people worldwide. The virus is 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. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.
About EnantaEnanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field. Enanta is developing novel protease, NS5A, nucleoside(tide) polymerase, and cyclophilin-based inhibitors targeted against the Hepatitis C virus (HCV). Additionally, the Company has created a new class of antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include overcoming resistance to superbugs, treating respiratory tract infections, and developing intravenous and oral treatments for hospital and community MRSA infections. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at www.enanta.com .
For Enanta Investor Relations, please contact:Paul Mellett617-607-0761
For Enanta Public Relations, please contact MacDougall Biomedical Communications:Kari Watson781-235-3060 or kwatson@macbiocom.com
SOURCE Enanta Pharmaceuticals, Inc.
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xconomy: Enanta has also retained the right to co-market the drug in the U.S. The product was recently cleared by regulators to start human clinical trials.
The alliance is just the latest in a feverish string of deals in the hepatitis C field. Within the past few months, Gilead Sciences made an $11 billion acquisition of Pharmasset, and Bristol-Myers Squibb acquired Inhibitex for $2.5 billion to obtain hepatitis C antiviral drugs from a class known as nucleotide polymerase inhibitors. Vertex Pharmaceuticals and Merck are attacking the virus with protease inhibitors that were approved by the FDA last year. Others, including Vertex and Roche, are testing another class of drugs known as non-nucleotide polymerase inhibitors-all in an effort to create a cocktail to stop the fast-mutating virus that causes chronic liver damage.
NS5A is a protein that scientists say plays a critical role in hepatitis C viral replication, and the body's ability to respond to traditional interferon therapy. The class has a few other well-known rivals in development, from Bristol-Myers, Cambridge, MA-based Idenix Pharmaceuticals, and San Francisco-based Presidio Pharmaceuticals.
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