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Enanta Announces AbbVie Submits New Drug Application to the Japanese Ministry of Health, Labour and Welfare for its Investigational, All-Oral, Treatment for Chronic Hepatitis C

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Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) , a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that AbbVie has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for AbbVie’s investigational, once-daily dosed, all-oral, ribavirin (RBV)-free and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment consisting of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r). The submission is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals in the treatment regimen. AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir.

AbbVie studied a two direct-acting antiviral regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, approximately 1.5 to 2 million people are living with HCV.1 Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the GT1b sub-type.2

AbbVie has previously announced that they expect 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.

The NDA is supported by the Phase 3 GIFT-I study, which met its primary endpoint achieving a 95 percent (n= 106/112) sustained virologic response rate at 12 weeks post-treatment (SVR12) in the sub-group of previously untreated non-cirrhotic adult genotype 1b (GT1b)-infected Japanese patients who were eligible for therapy with IFN and had a high viral load (>=100,000 IU/mL). Additionally, two patients (0.9 percent) discontinued treatment due to adverse events.

About GIFT-I Study
GIFT-I (M13-004) is a Phase 3, multi-center study designed to evaluate the efficacy and safety of 12 weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in adult Japanese patients (n=363) with chronic genotype 1b hepatitis C virus infection. Patients included those without cirrhosis as well as some patients with compensated cirrhosis, of whom some were new to therapy (treatment-na”ive) and others had failed previous treatment with interferon with or without ribavirin (treatment-experienced).

The study consists of two sub-studies. Sub-study one included patients without cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two included patients with compensated cirrhosis, who received open-label treatment with OBV/PTV/r.

Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.

In patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent placebo).

Protease Inhibitor Collaboration with AbbVie
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. Paritaprevir and ABT-493 are protease inhibitors identified through the collaboration. AbbVie is Abbott’s successor under the agreement and is responsible for all development and commercialization activities for paritaprevir, as well as ABT-493, the collaboration’s next-generation protease inhibitor.

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 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. 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 Statements 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, market acceptance of those regimens in Japan, the impact of competitive products on the use and sales of those regimens, and regulatory actions affecting clinical development of paritaprevir and clinical development of competitive product candidates in Japan. 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

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