March 04, 2015 7:02 AM ET

Biotechnology

Company Overview of Enanta Pharmaceuticals, Inc.

Company Overview

Enanta Pharmaceuticals, Inc., a biotechnology company, discovers and develops small molecule drugs for the infectious disease field in the United States. Its product portfolio includes ABT-450, a protease inhibitor that is in Phase III clinical trials for the treatment of hepatitis C virus (HCV); ABT-493, a next-generation protease inhibitor for HCV infection; EDP-239, an NS5A inhibitor for HCV infection; Cyclophilin inhibitor, which are in preclinical development stage for HCV infection treatment; and Nucleotide Polymerase inhibitor program for HCV infection. The company also develops Bicyclolide antibiotic products focuses on mechanisms gram-positive pathogens, including bacteria resistant...

500 Arsenal Street

Watertown, MA 02472

United States

Founded in 1995

52 Employees

Phone:

617-607-0800

Fax:

617-607-0530

Key Executives for Enanta Pharmaceuticals, Inc.

Chief Executive Officer, President and Director
Age: 58
Total Annual Compensation: $751.8K
Chief Financial Officer and Senior Vice President of Finance & Administration
Age: 59
Total Annual Compensation: $440.3K
Chief Scientific Officer and Senior Vice President of Research & Development
Age: 62
Total Annual Compensation: $514.1K
Compensation as of Fiscal Year 2014.

Enanta Pharmaceuticals, Inc. Key Developments

Enanta Pharmaceuticals, Inc. 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

Enanta Pharmaceuticals, Inc. 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 Enantaâ 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% of patients infected and, of those, about 95% 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% (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%) discontinued treatment due to adverse events. 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¯ve) 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% 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% OBV/PTV/r vs. 13.2% placebo), headache (8.8% OBV/PTV/r vs. 9.4% placebo), and oedema peripheral (5.1% OBV/PTV/r vs. 0% placebo).

Enanta Pharmaceuticals, Inc. Reports Consolidated Earnings Results for the First Quarter Ended December 31, 2014

Enanta Pharmaceuticals, Inc. reported consolidated earnings results for the first quarter ended December 31, 2014. For the quarter, the company's revenue was $77,498,000 compared to $893,000 for the three months ended December 31, 2013. The increase in revenue for the most recent quarter was primarily due to the achievement of a $75 million milestone payable from AbbVie for the U.S. regulatory approval of VIEKIRA PAK, as well as $1.4 million in royalty revenue, which was earned from a portion of AbbVie's net sales of VIEKIRA PAK in the U.S. from the December 19, 2014 approval date through December 31, 2014. Income from operations was $70,210,000 against loss from operations of $5,457,000 for the same period a year ago. Net income was $42,009,000 compared to a net loss of $5,370,000 for the same period in 2013. Diluted net earnings per share were $2.18 compared with net loss per share were $0.30 a year ago. The increase in net income during the three-month period ended December 31, 2014 was primarily due to the milestone amount of $75 million payable from AbbVie.

Enanta Announces 95% SVR12 rate in AbbVie’s Phase 3 Study of All-Oral Treatment for Hepatitis C Virus in Japanese Patients

Enanta Pharmaceuticals, Inc. announced Phase 3 results from the GIFT-1 study, AbbVie’s investigational, all-oral, ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBT/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95% (n= 106/112) sustained virologic response rate at 12 weeks post-treatment (SVR12) in the sub-group of previously untreated non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load. AbbVie’s investigational, two direct-acting antiviral (2-DAA) treatment used in this study consists of the fixed-dosed combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily. Paritaprevir (formerly known as ABT-450) 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 the collaboration’s lead compound, paritaprevir. In Japan, it is estimated that up to 2 million people are living with HCV. Genotype 1b is the most common sub-genotype in Japan affecting nearly half the people infected with HCV in that country. 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 tablet) in adult Japanese patients (n=363) with chronic genotype 1b (GT1b) hepatitis C virus (HCV) infection. Patients included were those without cirrhosis as well as some patients with compensated cirrhosis, of whom some were new to therapy (treatment-naïve) and others had failed previous treatment with interferon (IFN) with or without ribavirin (RBV) (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. The primary efficacy population comprised a sub-group of the treatment-naïve patient GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naïve patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (= 100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).

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