Enanta Announces Japanese Ministry of Health, Labour & Welfare Grants Priority Review for AbbVie’s Investigational HCV Regi...
March 14 2017 - 8:08AM
Business Wire
- Priority review in Japan follows EMA
accelerated assessment and U.S. FDA priority review
designations
- If approved, G/P may provide a shorter,
eight-week, once-daily, ribavirin-free cure* for the majority of
the patients living with hepatitis C in Japan1
- Glecaprevir is Enanta’s second protease
inhibitor being developed through its collaboration with AbbVie and
is one of the two new direct-acting antivirals (DAAs) in G/P
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 priority review has been granted by the Japanese
Ministry of Health, Labour and Welfare (MHLW) to AbbVie for its
investigational, pan-genotypic, ribavirin-free combination of
glecaprevir/pibrentasvir (G/P) for the treatment of all major
genotypes (GT1-6) of chronic hepatitis C virus (HCV) infection. The
NDA for the G/P regimen in Japan was submitted in February
2017.
“Receiving priority review in the U.S., the E.U. and now Japan
validates that there is continued unmet need for patients with HCV
around the world,” commented Jay R. Luly, Ph.D., President and
Chief Executive Officer, Enanta. “If G/P is approved, we look
forward to this important treatment option being available to the
estimated 1 million people in Japan living with HCV.”
The Japanese MHLW designates priority review to certain
medicines based on the clinical usefulness of the treatment and
severity of the disease. Japan has one of the highest rates of
hepatitis C infection in the industrialized world, with
approximately 1 million people living with the disease, 99 percent
of whom are infected with genotype 1 (GT1) or genotype 2 (GT2).1,2
If approved, G/P may provide a shorter, eight-week treatment
duration for GT1 and GT2 patients without cirrhosis, who make up
the majority of HCV patients, and an additional treatment option
for patients with any of genotypes 3-6. G/P is also intended to
address the needs of patients with specific treatment challenges,
including those with severe chronic kidney disease (CKD) and those
not cured with previous DAA treatment.
The New Drug Application (NDA) in Japan is supported by data
from the Phase 3 CERTAIN studies in Japanese patients and
supplemented with registrational studies in AbbVie’s G/P global
clinical development program, which evaluated more than 2,300
patients in 27 countries across all major HCV genotypes and several
special populations. Patient populations studied included GT1-6,
those new to treatment and the treatment-experienced, those with
compensated cirrhosis and without cirrhosis, and patients with
specific treatment challenges, including those with severe CKD, and
those not cured with a prior DAA-containing regimen. The global
program was designed to investigate a faster path to virologic
cure* for all major HCV genotypes (GT1-6) and with the goal of
addressing areas of continued unmet need.
*Patients with a sustained virologic response at 12 weeks
post-treatment (SVR12) are considered cured of hepatitis C.
About AbbVie’s G/P Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) global clinical
development program was designed to investigate a faster path to
virologic cure* for all major HCV genotypes (GT1-6) and with the
goal of addressing treatment areas of continued unmet need. In
Japan, AbbVie studied the G/P regimen in additional dedicated
clinical trials due to patient and viral characteristics specific
to the Japanese HCV patient population.
G/P is an investigational, pan-genotypic regimen that is being
evaluated as a potential cure in 8 weeks for HCV patients without
cirrhosis and who are new to treatment with direct-acting
antivirals (DAA), who make up the majority of HCV patients. AbbVie
is also studying G/P in patients with specific treatment
challenges, such as patients with genotype 3 HCV, patients who were
not cured with previous DAA treatment and those with chronic kidney
disease, including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two
distinct antiviral agents in a fixed-dose combination of
glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir
(120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral
tablets.
G/P is an investigational product and its safety and efficacy
have not been established in Japan.
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 DISCLAIMER
This press release contains forward-looking statements,
including statements with respect to the prospects for AbbVie’s G/P
regimen for 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 developing
glecaprevir) to obtain regulatory approvals of its
glecaprevir/pibrentasvir (G/P) combination and commercialize it
successfully; the regulatory and marketing efforts of others with
respect to competitive treatment regimens for HCV; regulatory and
reimbursement actions affecting G/P, any competitive regimen, or
both; the need to obtain and maintain patent protection for
glecaprevir and avoid potential infringement of the intellectual
property rights of others; 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 Gower, E. Global epidemiology and genotype distribution of the
hepatitis C virus infection. Journal of Hepatology 2014; 61:
S45-S57. Table 2
2 National Center for Global Health and Medicine. Hepatitis C.
Assessed January 2017. Available from:
http://www.kanen.ncgm.go.jp/cont/010/c_gata.html
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Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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