WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for AbbVie’s investigational, two direct-acting antiviral (2-DAA) combination of ombitasvir/paritaprevir/ritonavir for the treatment of genotype 1 (GT1) chronic hepatitis C (HCV) infection. This all-oral treatment is ribavirin (RBV)-free and interferon (IFN)-free and will be dosed once daily. The MHLW grants priority review to certain medicines on the basis of clinical usefulness and severity of the disease, including diseases like hepatitis C, which affects an estimated 1.5 to 2 million people in Japan.1 AbbVie’s investigational HCV treatment was submitted for marketing approval in Japan in February 2015. The New Drug Application is supported by the Phase 3 GIFT-I study in Japanese GT1b HCV patients.
AbbVie studied the 2-DAA regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, GT1 HCV accounts for 60 to 70 percent of all HCV patients and, of those, about 95 percent are infected with the GT1b sub-type.2
AbbVie has previously announced that it expects regulatory approval in Japan in the second half of 2015. Upon commercialization regulatory approval in Japan, Enanta will be entitled to a $30 million milestone payment from AbbVie. In addition, Enanta will be eligible to receive annually tiered royalties, ranging from the low double digits up to twenty percent, on 45% of AbbVie’s worldwide net sales of any 2-DAA paritaprevir-containing regimen.
Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two DAAs in the treatment regimen under the NDA in Japan. AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir. Paritaprevir is included in AbbVie’s HCV treatment regimens approved in the U.S. in late 2014 and in the E.U. in early 2015.
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 for viral infections and liver diseases. Enanta is discovering, and in some cases 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, and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Enanta’s lead protease inhibitor, paritaprevir, is part of AbbVie’s recently approved HCV treatment regimens. In addition, Enanta has a preclinical program in non-alcoholic steatohepatitis, or NASH, which is a condition that results in liver inflammation and damage caused by a buildup of fat in the liver.
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements, including with respect to the prospects for AbbVie’s paritaprevir-containing, 2-DAA regimen under development for HCV in Japan. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include the efforts of AbbVie (our collaborator on paritaprevir) regarding regulatory approval and commercialization in Japan for treatment regimens containing paritaprevir; the level of market acceptance and the pricing and rate of reimbursement for those regimens in Japan; the impact of competitive products on the use and sales of those regimens; regulatory actions affecting clinical development of competitive product candidates in Japan; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for the fiscal year ended September 30, 2014 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
1 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html
2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html. Accessed December 2014