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Enanta Pharmaceuticals Announces Results from Four All-Oral, Interferon-Free, Phase 3 Studies for the Treatment of Genotype 1



  Enanta Pharmaceuticals Announces Results from Four All-Oral,
  Interferon-Free, Phase 3 Studies for the Treatment of Genotype 1 Hepatitis C
  Virus Infection

  * Results confirm previously reported data in genotype 1 (GT1) patient
    populations demonstrating high sustained virologic response rates at 12
    weeks post-treatment (SVR[12])
  * Results demonstrate SVR[12] of 97 to 100% in GT1b patients
  * SVR[12] of 92 to 96% was shown in the difficult-to-treat GT1 cirrhotic
    patient population
  * AbbVie announced it expects U.S. launch in 2014

Business Wire

WATERTOWN, Mass. -- January 31, 2014

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced results from the
PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies. These studies are the
remaining four phase 3 studies of the six phase 3 registrational studies being
conducted by AbbVie for the treatment of genotype 1 (GT1) hepatitis C virus
(HCV) infection using a regimen containing Enanta’s lead protease inhibitor
ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting
antiviral regimen consisting of boosted protease inhibitor ABT-450/ritonavir,
NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. These
studies were conducted with and without ribavirin. The combination of the
three different mechanisms of action in this regimen interrupts the HCV
replication process with the goal of optimizing SVR rates across different
patient populations.

Results from these studies demonstrate high sustained virologic response rates
12 weeks post treatment (SVR[12]) and tolerability in these GT1 patients and
low rates of discontinuation due to adverse events.

A summary of AbbVie’s Phase 3 clinical trial results for the 3D regimen
consisting of ABT-450/ritonavir, ABT-267 and ABT-333 follows:

 
Study            Patient Type (number)     Treatment         Treatment     SVR[12]
                                           Regimen           Duration
                                             * 3D
                                               regimen       12 week       100%
                 GT1b                          (n=91)
PEARL-II         treatment-experienced       * 3D
                 (n=179)                       regimen
                                               with          12 weeks      97%
                                               ribavirin
                                               (n=88)
                                             * 3D
                                               regimen       12 weeks      99%
                 GT1b, treatment-naïve         (n=209)
PEARL-III        (n=419)                     * 3D
                                               regimen
                                               with          12 weeks      99%
                                               ribavirin
                                               (n=210)
                                             * 3D
                                               regimen       12 weeks      90%
                 GT1a, treatment-naïve         (n=205)
PEARL-IV         (n=305)                     * 3D
                                               regimen
                                               with          12 weeks      97%
                                               ribavirin
                                               (n=100)
                                             * 3D
                                               regimen
                 GT1 treatment-naïve           with          12 weeks      92%
                 and treatment-                ribavirin
TURQUOISE-II     experienced with              (n=208)
                 compensated                 * 3D
                 cirrhosis (n=380)             regimen
                                               with          24 weeks      96%
                                               ribavirin
                                               (n=172)
                                             * 3D
                 GT1 treatment-naïve           regimen
SAPPHIRE-I       (n=631)                       with          12 weeks      96%
                                               ribavirin
                                               (n=473)
                                             * 3D
                 GT1                           regimen
SAPPHIRE-II      treatment-experienced         with          12 weeks      96%
                 (n=394)                       ribavirin
                                               (n=297)
 

Overall, across the four studies, the three direct-acting antiviral regimen
was well tolerated with few adverse event-related discontinuations. The most
commonly reported adverse events in PEARL-II and PEARL-III were fatigue and
headache. In PEARL-IV and TURQUOISE-II, the most commonly reported adverse
events were fatigue, headache and nausea.

“We are pleased that SVR rates continue to be high in both treatment-naive and
treatment-experienced GT1 HCV patients with and without ribavirin, as well as
in the difficult-to-treat compensated cirrhotic patients. In addition, these
trials demonstrate the exceptional tolerability of the regimen, with less than
one percent (0.8%) of patients discontinuing therapy due to adverse events,”
said Jay R. Luly, Ph.D. President and CEO. “We are also pleased that AbbVie
has announced it is on track to begin major regulatory submissions early in
the second quarter of 2014.”

These six phase 3 trials included 2,308 patients from more than 25 countries
around the world. This is the only registrational program to include a
dedicated study of an all-oral regimen in patients with compensated cirrhosis.
In May 2013, AbbVie’s three direct-acting antiviral regimen with and without
ribavirin for GT1 HCV was designated as a Breakthrough Therapy by the U.S.
Food and Drug Administration (FDA). AbbVie has stated that it intends to
disclose detailed study results at future scientific congresses and in
publications.

About Study M13-389 (PEARL-II)

PEARL-II is a global, multi-center, randomized, open-label, controlled study
to evaluate the efficacy and safety of 12 weeks of treatment with the three
direct-acting antiviral regimen with and without ribavirin in non-cirrhotic,
GT1b HCV-infected, treatment-experienced adult patients.

The study population consisted of 179 GT1b treatment-experienced patients with
no evidence of liver cirrhosis: 91 patients were randomized to the regimen
without ribavirin for 12 weeks, and 88 patients were randomized to the regimen
plus ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91)
of patients achieved SVR[12], while 97 percent (n=85/88) achieved SVR[12] in
the ribavirin-containing arm.

The most commonly reported adverse events were fatigue and headache.
Discontinuations due to adverse events were reported in none of the patients
in the ribavirin-free arm and two (2 percent) patients in the
ribavirin-containing arm. There were no patients in either arm of the study
that experienced virologic relapse or breakthrough.

About Study M13-961 (PEARL-III)

PEARL-III is a global, multi-center, randomized, double-blind, controlled
study to evaluate the efficacy and safety of 12 weeks of treatment with the
three direct-acting antiviral regimen with and without ribavirin in
non-cirrhotic, GT1b HCV-infected, treatment-naïve adult patients.

The study population consisted of 419 GT1b treatment-naïve patients with no
evidence of liver cirrhosis; 209 patients were randomized to the regimen
without ribavirin for 12 weeks, and 210 patients were randomized to the
regimen plus ribavirin for 12 weeks. Following 12 weeks of treatment, 99
percent receiving the regimen without ribavirin (n=207/209) and 99 percent
receiving the regimen plus ribavirin (n=209/210) achieved SVR[12].

The most commonly reported adverse events were fatigue and headache. No
patient discontinued study drug due to adverse events. Virologic relapse or
breakthrough was noted in none of the patients receiving the regimen without
ribavirin and 0.5 percent of patients receiving the regimen plus ribavirin.

About Study M14-002 (PEARL-IV)

PEARL-IV is a global, multi-center, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of 12 weeks of
treatment with the three direct-acting antiviral regimen with and without
ribavirin in non-cirrhotic, GT1a HCV-infected, treatment-naïve adult patients.

The study population consisted of 305 GT1a treatment-naïve patients with no
evidence of liver cirrhosis; 205 patients were randomized to the regimen
without ribavirin for 12 weeks, and 100 patients were randomized to the
regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90
percent of patients receiving the regimen without ribavirin (n=185/205) and 97
percent receiving the regimen plus ribavirin (n=97/100) achieved SVR[12].

The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in two (1 percent)
patients receiving the regimen without ribavirin and no patients in the
ribavirin-containing arm. Virologic relapse or breakthrough was noted in 8
percent of patients receiving the regimen without ribavirin and 2 percent of
patients receiving the regimen with ribavirin.

About Study M13-099 (TURQUOISE-II)

TURQUOISE-II is the first phase III study completed exclusively in GT1
cirrhotic patients investigating an all-oral interferon-free regimen. It is a
global, multi-center, randomized, open-label study evaluating the efficacy and
safety of 12 or 24 weeks of treatment with the three direct-acting antiviral
regimen with ribavirin in cirrhotic, GT1a and GT1b HCV-infected,
treatment-naïve and treatment-experienced adult patients.

The study population consisted of 380 GT1a and GT1b, treatment-naïve and
treatment-experienced patients with compensated cirrhosis; 208 patients were
randomized to the regimen plus ribavirin for 12 weeks, and 172 patients were
randomized to the regimen plus ribavirin for 24 weeks. Following 12 weeks of
treatment, 92 percent of patients (n=191/208) achieved SVR[12]. Following 24
weeks of treatment, 96 percent of patients (n=165/172) achieved SVR[12].

The most commonly reported adverse events were fatigue, headache and nausea.
Discontinuations due to adverse events were reported in four (2 percent)
patients receiving the regimen with ribavirin for 12 weeks and four (2
percent) patients in the 24-week arm. Virologic relapse or breakthrough was
noted in 6 percent of patients in the 12-week arm and 2 percent in the 24-week
arm.

Additional information about AbbVie’s phase 3 studies can be found on
www.clinicaltrials.gov.

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 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.

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 with respect
to the clinical data and the planned regulatory submissions for the three
direct-acting antiviral HCV treatment regimen containing 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 of
the three direct-acting antiviral ABT-450-containing regimen, the development,
regulatory and marketing efforts of AbbVie (our collaborator on ABT-450),
clinical development of competitive product candidates, regulatory submissions
by AbbVie and its competitors in HCV and regulatory actions affecting the
three direct-acting antiviral ABT-450-containing regimen and competitive
regimens. 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:

Enanta Pharmaceuticals, Inc.
Investor:
Carol Miceli, 617-607-0710
cmiceli@enanta.com
Media:
Kari Watson, 781-235-3060
MacDougall Biomedical Communications
kwatson@macbiocom.com
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