Market Overview

Enanta Announces CHMP Grants Positive Opinion for an Eight-Week Treatment Option with AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) for Patients with Genotype 1b Chronic Hepatitis C

Share:





Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, announced today
that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has granted a positive opinion for an
eight-week treatment regimen of AbbVie's VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) as an option for previously untreated adult patients with
genotype 1b (GT1b) chronic HCV infection and minimal to moderate
fibrosis.*

VIEKIRAX + EXVIERA is currently approved in the European Union for use
as a 12-week treatment for GT1b chronic HCV-infected patients without
cirrhosis or with compensated cirrhosis. Paritaprevir is Enanta's lead
protease inhibitor identified within the ongoing Enanta-AbbVie
collaboration and one of the three direct-acting antivirals in VIEKIRAX
+ EXVIERA.

Approximately 160 million people worldwide are infected with HCV, with
GT1b being the most common subtype globally.2,5 In Europe,
this subtype accounts for approximately 47 percent of the estimated nine
million people infected with chronic HCV across the continent.3,4

The CHMP positive opinion is supported by data from the dedicated Phase
3b GARNET study. Results showed that with eight weeks of treatment with
VIEKIRAX + EXVIERA, 98 percent (n= 160/163) of previously untreated GT1b
chronic HCV infected patients without cirrhosis achieved sustained
virologic response at 12 weeks post-treatment (SVR12).1
The most commonly reported adverse events, occurring at rates equal to
or greater than 5 percent, were headache (21 percent), fatigue (17
percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6
percent) and asthenia (5 percent).

*When assessing severity of liver disease using non-invasive methods,
additional blood tests improve accuracy and should be undertaken prior
to 8 week treatment in all patients with moderate fibrosis.

About AbbVie's GARNET Study1

The Phase 3b GARNET study was a multicenter, open-label, single-arm
study, investigating the safety and efficacy of eight weeks of treatment
with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients
with GT1b chronic HCV infection without cirrhosis.1 The study
enrolled 166 patients across 20 sites around the world. Of the 166
patients enrolled, 163 patients had GT1b chronic HCV infection without
cirrhosis and three patients with other HCV genotypes were excluded from
the efficacy analysis. The primary endpoint was the percentage of
patients who achieved SVR12.

Two patients experienced post-treatment relapse and one discontinued due
to noncompliance. Less than one percent of patients experienced serious
adverse events or clinically significant (Grade ≥3) laboratory
abnormalities. One patient discontinued treatment on Day 45 due to an
adverse event but achieved SVR12.

Additional information about the GARNET study can be found on www.clinicaltrials.gov.

VIEKIRAX® + EXVIERA®

VIEKIRAX + EXVIERA is approved in the European Union for the treatment
of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including
patients with compensated cirrhosis. VIEKIRAX is approved in the
European Union for the treatment of genotype 4 (GT4) chronic HCV
infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir
150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir
25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of
dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice
daily. VIEKIRAX + EXVIERA is taken with or without ribavirin (RBV),
dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for
12 weeks with or without RBV, except in genotype 1a patients with
compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks
with RBV.

EU Indication

VIEKIRAX is indicated in combination with other medicinal products for
the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is
indicated in combination with other medicinal products for the treatment
of CHC in adults.

Important EU Safety Information

Contraindications:

VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic
impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing
medicinal products must discontinue them and switch to an alternative
method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not
give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong
or moderate enzyme inducers. Do not give EXVIERA with certain drugs that
are strong inhibitors of CYP2C8.

Special warnings and precautions for use

VIEKIRAX and EXVIERA are not recommended as monotherapy and should be
used in combination with other medicinal products for the treatment of
hepatitis C infection.

Risk of Hepatic Decompensation and Hepatic Failure in Patients with
Cirrhosis

VIEKIRAX and EXVIERA are not recommended in patients with moderate
hepatic impairment (Child-Pugh B). Patients with cirrhosis should be
monitored for signs and symptoms of hepatic decompensation, including
hepatic laboratory testing at baseline and during treatment.

ALT elevations

Transient elevations of ALT to >5x ULN without concomitant elevations of
bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were
more frequent in a subgroup who were using ethinyl estradiol-containing
contraceptives.

Pregnancy and concomitant use with ribavirin

Extreme caution must be taken to avoid pregnancy in female patients and
female partners of male patients when VIEKIRAX with or without EXVIERA
is taken in combination with ribavirin, see section 4.6 and refer to the
Summary of Product Characteristics for ribavirin for additional
information.

Use with concomitant medicinal products

Use caution when administering VIEKIRAX with fluticasone or other
glucocorticoids that are metabolized by CYP3A4. A reduction in
colchicine dosage or interruption in colchicine is recommended in
patients with normal renal or hepatic function. VIEKIRAX with or without
EXVIERA is expected to increase exposure of statins so certain statins
need to be discontinued or dosages reduced. Low dose ritonavir, which is
part of VIEKIRAX, may select for PI resistance in HIV co-infected
patients without ongoing antiretroviral therapy. HIV co-infected
patients without suppressive antiretroviral therapy should not be
treated with VIEKIRAX.

Adverse Reactions

Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with
RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu

Globally, prescribing information varies; refer to the individual
country product label for complete information.

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 for viral
infections and liver diseases. Enanta's research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta's collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie's HCV regimens, and glecaprevir (ABT-493), Enanta's
second protease inhibitor product, which AbbVie is developing as part of
its investigational HCV regimen of glecaprevir/pibrentasvir (G/P) now in
registration in the U.S., the E.U. and Japan. Royalties and any further
milestone payments from this collaboration will provide funding for
Enanta's earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta's programs and pipeline.

Forward Looking Statements

This press release contains forward-looking statements, including
statements with respect to the prospects for approval of the label
expansion for AbbVie's VIEKIRAX + EXVIERA regimen as an eight-week
treatment in the E. U. for GT1b HCV.. Statements that are not historical
facts are based on management's current expectations, estimates,
forecasts and projections about Enanta's business and the industry in
which it operates and 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 and risks that may affect actual results
include: the efforts of AbbVie (our collaborator on paritaprevir that is
marketing VIEKIRAX + EXVIERA) to obtain regulatory approval of the label
expansion for VIEKIRAX + EXVIERA in the E.U.; the development,
regulatory and marketing efforts of others with respect to competitive
HCV treatment regimens; and other risk factors described or referred to
in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year
ended September 30, 2016 and other periodic reports filed more recently
with the Securities and Exchange Commission. 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.

________________________________________

1 Welzel, T. et al. GARNET: High SVR Rates Following
Eight-Week Treatment with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir
for Patients with HCV Genotype 1b Infection. Presented at the European
Association for the Study of the Liver Special Conference: New
Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure,
Paris, France on September 23-24, 2016.

2 Gower E. et al. Global epidemiology and genotype
distribution of the hepatitis C virus infection. Journal of Hepatology
Update: Hepatitis C, 2014; 61: S45-S57.

3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman
LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver
Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier. 2010:1313-1335.

4 Hatzakis A. et al. The state of hepatitis B and C in
Europe: report from the hepatitis B and C summit conference. Journal of
Viral Hepatitis, 2011; 18 (Suppl. 1): 1-16.

5 Lavanchy D. Evolving epidemiology of hepatitis C virus.
Clin Microbiol Infect. 2011; 17(2):107-15.

View Comments and Join the Discussion!
 

Partner Center