Enanta Pharmaceuticals Announces AbbVie’s Investigational Treatment Regimen for Genotype 1 Chronic Hepatitis C Granted Prio...
April 15 2015 - 7:05PM
Business Wire
- AbbVie’s treatment for hepatitis C
patients in Japan consists of a 12-week, two direct-acting
antiviral (2-DAA), fixed-dose combination of paritaprevir/ritonavir
with ombitasvir, dosed once daily
- Regimen contains Enanta’s lead protease
inhibitor, paritaprevir
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
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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