Enanta Pharmaceuticals Announces U.S. Regulatory Approval of TECHNIVIE (ombitasvir, paritaprevir and ritonavir) tablets

Enanta Pharmaceuticals, Inc.

, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) approved AbbVie's TECHNIVIE™ (ombitasvir, paritaprevir and ritonavir) tablets in combination with ribavirin (RBV) for the treatment of non-cirrhotic adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection. "The approval of TECHNIVIE is an important advancement in the care of patients with genotype 4 HCV," commented Jay R. Luly, President and CEO. "These difficult-to-treat patients now have a treatment option with high cure rates available to them and we are proud to have paritaprevir be part of this regimen." Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals (2-DAA) in AbbVie's TECHNIVIE. Forty five percent of AbbVie's worldwide net sales of the 2-DAA regimen will be included in the paritaprevir net sales on which Enanta is eligible to receive annually tiered royalties, ranging from the low double digits up to twenty percent. AbbVie is responsible for all worldwide development and commercialization of TECHNIVIE and other HCV treatment regimens. Paritaprevir/ritonavir and ombitasvir, AbbVie's NS5A inhibitor, are also included in AbbVie's VIEKIRA PAK™, which was approved in the U.S. in late 2014 for patients with GT1 HCV infection. The Centers for Disease Control and Prevention (CDC) estimates that 2.7 million people have chronic HCV infection in the U.S.1 There are six major HCV genotypes (GT1-6). While genotype 1 (GT1) is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases2, GT4 infection is estimated to account for approximately 1.1 percent of HCV infections in the U.S.3 About the PEARL-I Study This approval of TECHNIVIE is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that evaluated the efficacy and safety of TECHNIVIE in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking TECHNIVIE without RBV. In the treatment-naïve group without RBV, on-treatment virologic breakthrough was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms. There were no discontinuations due to adverse events in these patients. The most commonly reported treatment-emergent adverse events (greater than 10 percent in any group) observed in patients receiving TECHNIVIE or TECHNIVIE with RBV, respectively, were asthenia (weakness) (25-29 percent), fatigue (7-15 percent), nausea (9-14 percent) and insomnia (5-13 percent). Four patients who received TECHNIVIE with RBV experienced decreased hemoglobin (anemia) which required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. All patients treated with TECHNIVIE and RBV achieved SVR12.