Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver Meeting (AASLD)

  Enanta Announces New Data on ABT-450 Regimens to be Presented at The Liver
  Meeting (AASLD)

AASLD Annual Meeting 2013

Business Wire

WATERTOWN, Mass. -- October 1, 2013

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 Responders
    Lawitz, 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 Study
    Poordad, 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 Weeks
    Bourliere, 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 Reductions
    Cohen, 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 Study
    Baran, 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.
developmentcosts and U.S. commercialization efforts(sales and promotion
costs) for the additional protease inhibitor inexchange for 40 percent of any
U.S. profits ultimately achieved afterregulatory approval instead
ofreceiving payments for U.S. commercialregulatory approval milestones and
royalties on U.S. sales of that 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 in the infectious disease field.
Enanta is discovering and 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 (partnered with Novartis) and nucleotide polymerase – as well as a
host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin.
Additionally, Enanta has created a new class of antibiotics, called
Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus
on developing an intravenous and oral treatment for hospital and community
MRSA (methicillin-resistant Staphylococcus aureus) infections.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including with respect
to clinical data, plans for announcing additional data, and the planned
clinical development of ABT-450. 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 final results of ongoing clinical trials, the development and
marketing efforts of AbbVie (our collaborator on ABT-450), regulatory actions
affecting clinical development of ABT-450 and clinical development of
competitive product candidates. 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.

Contact:

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
 
Press spacebar to pause and continue. Press esc to stop.