AbbVie’s approved interferon-free and ribavirin-free treatment
option for Japanese patients with most common type of hepatitis in
Japan, including patients with compensated cirrhosis
VIEKIRAX consists of a two direct-acting antiviral, fixed-dose
combination of paritaprevir/ritonavir with ombitasvir, dosed once daily1
VIEKIRAX contains Enanta’s lead protease inhibitor, paritaprevir
WATERTOWN, Mass.--(BUSINESS WIRE)--Sep. 28, 2015--
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved
AbbVie’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir), as a new
interferon-free and ribavirin-free treatment option for adult patients
in Japan with chronic genotype 1 (GT1) hepatitis C virus (HCV)
infection, including those with compensated liver cirrhosis.1
VIEKIRAX consists of two-direct-acting antiviral (2-DAA), fixed-dose
tablets containing paritaprevir/ritonavir with ombitasvir. VIEKIRAX is
approved in Japan using once daily dosing for 12 weeks for GT1 HCV
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the two DAAs in
Japan has one of the highest rates of hepatitis C infection in the
industrialized world, with approximately 1.5 to 2 million people living
with HCV.2, 3 Genotype 1 is the most common HCV genotype in
Japan with 60 to 70 percent of patients infected and, of those, about 95
percent are infected with the genotype 1b (GT1b) sub-type.4
Enanta expects to earn and receive a $30 million milestone payment in
the quarter ending December 31, 2015 upon price reimbursement approval
of VIEKIRAX in Japan. In addition, forty five percent of AbbVie’s net
sales of the 2-DAA regimen in Japan will be included in the worldwide
paritaprevir net sales on which Enanta is eligible to receive annually
tiered royalties, ranging from the low double digits up to twenty
percent. AbbVie is responsible for all worldwide development and
commercialization of VIEKIRAX and other HCV treatment regimens
containing paritaprevir. Paritaprevir/ritonavir and ombitasvir, AbbVie’s
NS5A inhibitor, are also included in AbbVie’s 3-DAA VIEKIRA PAK™
regimen, which was approved in the U.S. in late 2014 for patients with
GT1 HCV infection. VIEKIRAX was first approved under that name in Europe
in January 2015.
“The approval of VIEKIRAX in Japan marks another major territory in
which a regimen containing paritaprevir is approved,” stated Jay R.
Luly, Ph.D., President and CEO. “VIEKIRAX offers HCV patients in Japan
an all-oral, once daily treatment option that has demonstrated high cure
rates. We are proud that paritaprevir is part of this regimen.”
The approval was supported by the phase 3 GIFT-I study.1 An
overall 95 percent (n=140/148) of treatment-naïve and 94 percent
(n=102/109) of treatment-experienced GT1b HCV infected patients achieved
SVR12 with VIEKIRAX.1
The primary endpoint was achieved, demonstrating 95 percent (n=106/112)
SVR12 in a sub-group of treatment-naïve, non-cirrhotic,
adult, GT1b HCV infected Japanese patients who were eligible for therapy
with interferon (IFN) and had a high viral load. A secondary endpoint in
GT1b HCV patients with compensated cirrhosis achieved 91 percent
Across all treatment arms, three patients (n=3/363) experienced
on-treatment virologic failure, eight patients (n=8/354) experienced
post-treatment relapse and three patients discontinued treatment due to
adverse events. The most commonly reported adverse events (>5 percent in
any arm) were nasopharyngitis, headache, peripheral edema, nausea,
pyrexia and decreased platelet count.5
In April 2015, the Japanese MHLW granted AbbVie priority review for
VIEKIRAX on the basis of clinical usefulness of the treatment and
recognizing the severity and unmet need of HCV in Japan.
About the GIFT-I Study5
GIFT-I comprises 363 patients in two sub-studies, one of which had two
arms (Arms A and B).
In sub-study 1,321 genotype 1b (GT1b) patients without cirrhosis, both
treatment-naïve and interferon (IFN) [with or without ribavirin (RBV)]
treatment-experienced, were randomized to receive either
ombitasvir/paritaprevir/ritonavir (Arm A) [OBV/PTV/r] or placebo (Arm B)
[2:1 randomization ratio, stratified by treatment history, past
response, viral load and IFN eligibility]. Patients initially randomized
to placebo (Arm B) then received OBV/PTV/r for an additional 12 weeks of
open-label treatment. Sustained virologic response was assessed 12 weeks
post-treatment (SVR12) as a primary efficacy endpoint in a
sub-group of previously untreated, non-cirrhotic GT1b patients who were
eligible for therapy with IFN and had a high viral load, defined as an
HCV RNA level ≥ 100,000 IU/mL and received at least one dose of the
double-blind, active study drug.
In sub-study 2, 42 GT1b treatment-naïve and IFN (with or without RBV)
treatment-experienced patients with compensated cirrhosis received
open-label treatment for 12 weeks (Arm C) with SVR12 and
assessed as a secondary efficacy endpoint.
One patient from each arm (n=3/363) experienced on-treatment virologic
failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4%
(n=1/42)]. Across all arms, eight patients (n=8/354) experienced
post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105);
Arm C, 5.0% (n=2/40)].
AbbVie studied its two direct-acting antiviral treatment regimen without
RBV in Japan due to patient and viral characteristics specific to the
Japanese population, including high prevalence of GT1b.
About VIEKIRAX in Japan
Indication in Japan
VIEKIRAX is indicated for the improvement of viremia in chronic
hepatitis C or compensated hepatic cirrhosis C in patients of serogroup
1 (genotype 1).
Summary of Safety Information
VIEKIRAX is contraindicated in patients with a history of known
hypersensitivity to an ingredient in VIEKIRAX, patients with severe
hepatic impairment (Child-Pugh C) or patients being treated with the
following drugs: azelnidipine, triazolam, iv midazolam, blonanserin,
pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine
maleate, methylergometrine maleate, sildenafil citrate [Revatio],
tadalafil [Adcirca], rivaroxaban, vardenafil hydrochloride hydrate,
riociguat, simvastatin, atorvastatin calcium hydrate, carbamazepine,
phenytoin, phenobarbital, rifampin, efavirenz, foods containing St.
John's Wort (Hypericum perforatum), ethinyl estradiol-containing
Precautions for Use
Positive result for HCV RNA should be confirmed before administering
VIEKIRAX and decompensated cirrhosis should be excluded.
When VIEKIRAX is used for patients co-infected with HIV/HCV, administer
VIEKIRAX only to patients whose virological suppression has been
achieved by anti-HIV therapy as ritonavir may cause resistance against a
HIV protease inhibitor.
During the administration of VIEKIRAX, perform liver function tests
regularly because hepatic function disorder may occur.
Co-administration of VIEKIRAX with drugs that are substrates of CYP3A4,
P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma
concentrations of such drugs, potentially requiring dose adjustment or
The safety of VIEKIRAX in pregnant women has not been established.
VIEKIRAX should be used in pregnant women and women who may possibly be
pregnant only if the expected therapeutic benefits outweigh the possible
risks associated with treatment.
Do not administer VIEKIRAX to nursing mothers. If VIEKIRAX is
administered to a nursing mother by necessity, breast feeding must be
discontinued during treatment.
Safety and effectiveness have not been established in children.
Major adverse reactions included peripheral edema in 15 subjects (4.1%),
headache in 12 subjects (3.3%) and nausea in 10 subjects (2.8%)
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 has developed novel protease and
NS5A inhibitors that are members of the direct-acting-antiviral (DAA)
inhibitor classes designed for use against the hepatitis C virus (HCV).
Enanta’s protease inhibitors partnered with AbbVie include paritaprevir,
which is contained in AbbVie’s marketed DAA regimens for HCV, and
ABT-493, Enanta’s next generation protease inhibitor completing phase 2
development. Enanta also has a program to develop a host-targeted
antiviral (HTA) inhibitor class for HCV targeted against cyclophilin, as
well as another DAA program to develop nucleotide polymerase inhibitors.
In addition, Enanta has other preclinical programs, including one in
non-alcoholic steatohepatitis, or NASH, which is a condition that
results in liver inflammation and liver damage caused by a buildup of
fat in the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with
respect to the prospects for AbbVie’s VIEKIRAX and the expected timing
of price reimbursement approval in Japan and the related milestone
payment to Enanta. 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 paritaprevir) regarding price reimbursement
approval and commercialization of VIEKIRAX in Japan; the level of market
acceptance and the pricing and rate of reimbursement in Japan for
VIEKIRAX and for competitive treatment regimens; the impact of
competitive products on the use and sales of VIEKIRAX in Japan; 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,
2014 and other periodic reports filed more recently with the United
States 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 VIEKIRAX [package insert]. Tokyo, Japan: AbbVie Ltd; 2015.
2 Kohnodai Hospital. National Center for Global Health and
Medicine [cited 20 February 2013]. Available from:http://www.ncgm.go.jp/center/forpatient_hcv.html
3 Gower, E. Global epidemiology and genotype distribution of
the hepatitis C virus infection. Journal of Hepatology 2014; 61:
S45-S57, Table 2.
4 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013;
10: 553-562. Available from: http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
5 Kumada H, et al. Randomized phase 3 trial of
ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype
1b-infected Japanese patients with or without cirrhosis. Hepatology.
2015 Jul 3. doi: 10.1002/hep.27972.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150928005625/en/
Source: Enanta Pharmaceuticals, Inc.
Enanta Pharmaceuticals, Inc.
Kari Watson, 781-235-3060