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Enanta Announces New Data On ABT-450 Regimens To Be Presented At The Liver Meeting (AASLD)

Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that six abstracts reporting results of regimens containing ABT-450, Enanta’s lead protease inhibitor for hepatitis C virus (HCV), have been accepted for presentation at The Liver Meeting, the 64 th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place November 1-5, 2013 in Washington, D.C. Abstracts can now be viewed at the AASLD website at www.aasld.org.

There will be an oral presentation at AASLD highlighting data from study M13-393 (PEARL-I). PEARL-I is an interferon-free and ribavirin-free 320-patient study being conducted by Abbvie to evaluate the once-daily, two-DAA regimen consisting of ABT-450/r + ABT-267 in GT-1b and GT-4 HCV patients. SVR4 rates were 100% (39/39) in GT-1b treatment-naïve patients and 87.9% (29/33) among prior null responders (observed data). SVR12 rates will be presented during an oral presentation of this data on November 3.

Abstracts reporting regimens containing ABT-450 are listed below:

Oral Presentation:

  • #75 - Interferon and Ribavirin-Free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-naïve Patients and Prior Null RespondersLawitz, et al., November 3, 2013, 5:15 PM ET

Poster Presentations:

  • #1089 - Low Relapse Rate Leads to High Concordance of SVR4 and SVR12 with SVR24 After Treatment with ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients with Chronic HCV Genotype 1 Infection in the AVIATOR StudyPoordad, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
  • #1096 - High Medication Adherence in HCV-Infected Patients taking a Triple-DAA Regimen for 12 WeeksBourliere, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
  • #1125 - HCV RNA “Target Detected” after “Target Not Detected” During IFN-Free Treatment: Time to Worry or Not?M King, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
  • #1118 - Safety of Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267 for the Treatment of HCV Genotype 1 Infection and Efficacy in Subjects with Ribavirin Dose ReductionsCohen, et al., November 3, 2013, 8:00 AM – 5:30 PM ET
  • #1113 - Health-Related Quality of Life (HRQoL), Health State, Function and Wellbeing of Chronic HCV Patients Treated with Interferon-Free, Oral DAA Regimens: Patient Reported Outcome (PRO) Results from the AVIATOR StudyBaran , et al., November 3, 2013, 8:00 AM – 5:30 PM ET

Protease Inhibitor Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories)

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. ABT-450 is a protease inhibitor identified as a lead compound through the collaboration. Under the agreement, AbbVie (as the successor to Abbott) is responsible for all development and commercialization activities for ABT-450. Enanta received $57 million in connection with signing the collaboration agreement, has received $55 million in subsequent clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) for the additional protease inhibitor in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales of that protease inhibitor.

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