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 Japanese Ministry of Health, Labour and Welfare (MHLW) has
granted priority review for AbbVie’s investigational, two direct-acting
antiviral (2-DAA) combination of ombitasvir/paritaprevir/ritonavir for
the treatment of genotype 1 (GT1) chronic hepatitis C (HCV) infection.
This all-oral treatment is ribavirin (RBV)-free and interferon
(IFN)-free and will be dosed once daily. The MHLW grants priority review
to certain medicines on the basis of clinical usefulness and severity of
the disease, including diseases like hepatitis C, which affects an
estimated 1.5 to 2 million people in Japan.1 AbbVie’s
investigational HCV treatment was submitted for marketing approval in
Japan in February 2015. The New Drug Application is supported by the
Phase 3 GIFT-I study in Japanese GT1b HCV patients.
AbbVie studied the 2-DAA regimen without RBV in Japan due to patient and
viral characteristics specific to the Japanese population, including
high prevalence of GT1b. In Japan, GT1 HCV accounts for 60 to 70 percent
of all HCV patients and, of those, about 95 percent are infected with
the GT1b sub-type.2
AbbVie has previously announced that it expects 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. In addition, Enanta will be eligible to receive
annually tiered royalties, ranging from the low double digits up to
twenty percent, on 45% of AbbVie’s worldwide net sales of any 2-DAA
paritaprevir-containing regimen.
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the two DAAs in the
treatment regimen under the NDA in Japan. AbbVie is responsible for all
development and commercialization activities for regimens that contain
paritaprevir. Paritaprevir is included in AbbVie’s HCV treatment
regimens approved in the U.S. in late 2014 and in the E.U. in early 2015.
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. Enanta’s lead
protease inhibitor, paritaprevir, is part of AbbVie’s recently approved
HCV treatment regimens. 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 Statement 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; the level of market acceptance and the
pricing and rate of reimbursement for those regimens in Japan; the
impact of competitive products on the use and sales of those regimens;
regulatory actions affecting clinical development of competitive product
candidates 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 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 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
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