Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in Chronic Hepatitis C Patients with Cirrhosis being

  Enanta Pharmaceuticals Announces Detailed Data from TURQUOISE-II Study in
  Chronic Hepatitis C Patients with Cirrhosis being Presented at the European
  Association for the Study of the Liver (EASL) Meeting

  *In patients with compensated liver cirrhosis and genotype 1 (GT1) chronic
    hepatitis C virus, TURQUOISE-II demonstrated SVR[12 ]rates of 91.8% and
    95.9% after 12 and 24 weeks of treatment, respectively
  *TURQUOISE-II is the largest phase 3, all-oral, Interferon-free study in
    cirrhotic patients with hepatitis C virus conducted to date

Business Wire

WATERTOWN, Mass. -- April 12, 2014

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 detailed results from AbbVie’s
pivotal phase 3 TURQUOISE-II study, will be presented as a late-breaking oral
presentation today at the International Liver Congress (ILC), which is the
49th Annual Meeting of the European Association for the Study of the Liver
(EASL). Results from the TURQUOISE-II study were featured in the ILC press
conference yesterday and were published on-line in the New England Journal of
Medicine.

The TURQUOISE-II study reports results from AbbVie’s investigational three
direct-acting antiviral regimen containing ABT-450, Enanta’s lead protease
inhibitor discovered through Enanta’s collaboration with AbbVie. The regimen
consists of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor
ABT-267, and non-nucleoside polymerase inhibitor ABT-333.

TURQUOISE-II is a global, multi-center, randomized, open-label study
evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with
AbbVie's three direct-acting antiviral regimen with ribavirin (RBV) in adult
patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with
compensated liver cirrhosis. Patients achieved sustained virologic response
rates 12 weeks post-treatment (SVR[12]) of 91.8 percent and 95.9 percent in
the 12-week and 24-week treatment arms, respectively. Patients in the study
were either new to therapy or treatment-experienced (failed previous treatment
with pegylated interferon and RBV).

                                                                    
TURQUOISE-II Results
                                 12-Week Arm            24-Week Arm
                             SVR[12]             SVR[12]            

                                 (n=208)                (n=172)
All GT1                       91.8%               95.9%              
                                 (n=191/208)            (n=165/172)
GT1a                          88.6%               94.2%              
                                 (n=124/140)            (n=114/121)
New to therapy                92.2% (n=59/64)     92.9% (n=52/56)    
GT1a treatment-experienced                                         
Prior null responders         80.0% (n= 40/50)    92.9% (n=39/42)    
Prior relapsers               93.3% (n= 14/15)    100.0% (n=13/13)   
Prior partial responders      100.0% (n=          100.0% (n=10/10)   
                                 11/11)
GT1b                          98.5% (n=67/68)     100.0% (n=51/51)   
New to therapy                100.0% (n=          100.0% (n=18/18)   
                                 22/22)
GT1b treatment-experienced                                         
Prior null responders         100.0% (n=14/14)    100.0% (n=10/10)   
Prior relapsers               100.0% (n=25/25)    100.0% (n=20/20)   
Prior partial responders      85.7% (n= 6/7)      100.0% (n=3/3)     
                                                                             

Discontinuation rates due to adverse events were 1.9 percent (four patients)
and 2.3 percent (four patients) in the 12-week and 24-week arms, respectively.
The most commonly reported adverse events (>10 percent in either arm) in
TURQUOISE-II were fatigue, headache, nausea, pruritus, insomnia, diarrhea,
asthenia, rash, cough, irritability, anemia and dyspnea.

On-treatment virologic failure occurred in one patient (0.5 percent) in the
12-week arm and three patients (1.7 percent) in the 24-week arm. In addition,
12 patients (5.9 percent) in the 12-week arm and one patient (0.6 percent) in
the 24-week arm experienced relapse within 12 weeks post-treatment.

“Data presented to date from AbbVie’s three direct-acting antiviral regimen
with and without ribavirin have demonstrated high SVR rates across a range of
GT1 patient populations,” said Jay R. Luly, Ph.D., President and CEO. “In
addition, the positive results from the TURQUOISE-II study have demonstrated
that this regimen with ribavirin provides high SVR rates in the
difficult-to-treat, cirrhotic GT1 patients.”

Additional results from studies using AbbVie’s three-direct-acting antiviral
regimen containing ABT-450 being presented at the ILC today include:

  *PEARL-III late-breaker poster: A phase 3 study examining the regimen for
    12 weeks with or without RBV in non-cirrhotic GT1b HCV-infected adult
    patients who were new to therapy.
  *M12-999 oral presentation: Interim results of a phase II examining the
    regimen with RBV for 24 weeks in non-cirrhotic liver transplant recipients
    with recurrent GT1 HCV infection

Additional information about AbbVie’s phase III studies can be found on
www.clinicaltrials.gov.

About ABT-450

ABT-450 is an NS3 protease inhibitor discovered through Enanta’s collaboration
with AbbVie. AbbVie and Enanta have an agreement to collaborate on the
discovery, development and commercialization of HCV NS3 and NS3/4A protease
inhibitors. Protease inhibitors play an essential role in the viral life cycle
of the hepatitis C virus (HCV). Inhibition of the protease prevents
non-structural (NS) proteins from forming and thereby prevents replication and
survival of the HCV virus. ABT-450 is part of AbbVie’s investigational regimen
for HCV that consists of boosted protease inhibitor ABT-450/ritonavir
(referred to as ABT-450/r), NS5A inhibitor ABT-267 and non-nucleoside
polymerase inhibitor ABT-333.

About Hepatitis C Virus (HCV)

Hepatitis C is a liver disease affecting over 170 million people worldwide.
The virus is typically spread through direct contact with the blood of an
infected person. Hepatitis C increases a person’s risk of developing chronic
liver disease, cirrhosis, liver cancer and death. Patients with compensated
cirrhosis have a liver that is heavily scarred but that can still perform many
important bodily functions with few or no symptoms. There is an acute need for
new HCV therapies that are safer and more effective for many variants of the
virus.

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 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 (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 statements
with respect to the prospects for AbbVie’s HCV treatment regimen containing
ABT-450 that is being developed as a potential treatment across a range of GT1
patient populations. 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 ABT-450) to obtain regulatory approvals
and commercialize treatment regimens containing ABT-450, the development,
regulatory and marketing efforts of others with respect to competitive
treatment regimens, regulatory actions affecting any ABT-450-containing
regimen, any competitive regimen, or both, and the level of market acceptance
and the rate of reimbursement for any ABT-450-containing regimen. 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
 
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