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 AbbVie has submitted a New Drug Application (NDA) to the Japanese
Ministry of Health, Labour and Welfare (MHLW) seeking approval for
AbbVie’s investigational, once-daily dosed, all-oral, ribavirin
(RBV)-free and interferon (IFN)-free, 12-week, two direct-acting
antiviral treatment consisting of ombitasvir/paritaprevir/ritonavir
(OBV/PTV/r). The submission is for the treatment of patients with
genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the two direct-acting
antivirals in the treatment regimen. AbbVie is responsible for all
development and commercialization activities for regimens that contain
paritaprevir.
AbbVie studied a two direct-acting antiviral regimen without RBV in
Japan due to patient and viral characteristics specific to the Japanese
population, including high prevalence of GT1b. In Japan, approximately
1.5 to 2 million people are living with HCV.1 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 GT1b
sub-type.2
AbbVie has previously announced that they expect regulatory approval in
Japan in the second half of 2015. Upon commercialization regulatory
approval in Japan, Enanta will be entitled to a $30 million milestone
payment from AbbVie.
The NDA is supported by the Phase 3 GIFT-I study, which met its primary
endpoint achieving a 95 percent (n= 106/112) sustained virologic
response rate at 12 weeks post-treatment (SVR12) in the
sub-group of previously untreated non-cirrhotic adult genotype 1b
(GT1b)-infected Japanese patients who were eligible for therapy with IFN
and had a high viral load (≥100,000 IU/mL). Additionally, two patients
(0.9 percent) discontinued treatment due to adverse events.
About GIFT-I Study
GIFT-I (M13-004) is a Phase 3,
multi-center study designed to evaluate the efficacy and safety of 12
weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in
adult Japanese patients (n=363) with chronic genotype 1b hepatitis C
virus infection. Patients included those without cirrhosis as well as
some patients with compensated cirrhosis, of whom some were new to
therapy (treatment-naïve) and others had failed previous treatment with
interferon with or without ribavirin (treatment-experienced).
The study consists of two sub-studies. Sub-study one included patients
without cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two
included patients with compensated cirrhosis, who received open-label
treatment with OBV/PTV/r.
Within the primary efficacy patient population, there were no
on-treatment virologic failures and 2.8 percent of patients (n=3/109)
experienced relapse.
In patients without cirrhosis, the most commonly reported adverse events
in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs.
13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent
placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent
placebo).
Protease Inhibitor Collaboration with AbbVie
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. Paritaprevir and ABT-493 are protease inhibitors
identified through the collaboration. AbbVie is Abbott’s successor under
the agreement and is responsible for all development and
commercialization activities for paritaprevir, as well as ABT-493, the
collaboration’s next-generation 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 for viral infections and liver diseases. 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, and nucleotide polymerase – as
well as a host-targeted antiviral (HTA) inhibitor class targeted against
cyclophilin. In addition, Enanta has a preclinical program in
non-alcoholic steatohepatitis, or NASH, which is a condition that
results in liver inflammation and 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 paritaprevir-containing, 2-DAA regimen under
development for HCV in Japan. 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 regulatory approval and
commercialization in Japan for treatment regimens containing
paritaprevir, market acceptance of those regimens in Japan, the impact
of competitive products on the use and sales of those regimens, and
regulatory actions affecting clinical development of paritaprevir and
clinical development of competitive product candidates in Japan. 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 Kohnodai Hospital. National Center for Global Health and
Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html
2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013;
10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html.
Accessed December 2014
Copyright Business Wire 2015