Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a chemistry-driven
biotechnology company dedicated to creating and developing small
molecule drugs for viral infections and liver diseases, today
announced that AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir), a new
once-daily, ribavirin-free treatment approved for adults with
chronic hepatitis C virus (HCV) infection across all major
genotypes (GT1-6) in Japan, has been approved for reimbursement by
the Ministry of Health, Labour and Welfare and is now commercially
available in Japan. MAVIRET is the first and only 8-week treatment
in Japan for genotype 1 (GT1) and genotype 2 (GT2) HCV infected
patients without cirrhosis and who are new to direct-acting
antiviral (DAA) treatment.*
Glecaprevir, one of the two new, direct-acting antivirals (DAAs)
in MAVIRET (marketed as MAVYRET™ in the U.S.), is Enanta’s second
protease inhibitor being developed and commercialized by AbbVie.
With the reimbursement approval in Japan, Enanta has now earned a
$15 million milestone payment, which it expects to receive this
quarter.
“Enanta has now earned all of the clinical and regulatory
milestones for two products, paritaprevir and now glecaprevir,
within the Enanta/AbbVie HCV collaboration,” stated Jay R. Luly,
Ph.D., President and CEO. “AbbVie has recently stated that it is
confident that the MAVIRET combination therapy will allow AbbVie to
significantly grow its position within the HCV market globally, and
that it will ultimately deliver a multibillion-dollar peak-year of
sales. We are fortunate to have a partner that is bringing such
important therapies as MAVIRET to HCV patients in markets around
the world.”
Japan has one of the highest rates of HCV infection in the
industrialized world, with 97 percent of its HCV patients infected
with GT1 or GT2 chronic HCV.2,3 Japan also has the highest
prevalence of liver cancer amongst the industrialized countries,
with chronic hepatitis C and its complications being the leading
causes.4
The New Drug Application (NDA) for MAVIRET in Japan was filed in
February 2017, designated for priority review by the Ministry of
Health, Labour and Welfare in March 2017, and granted marketing
authorization in September 2017.
*Patients without previous treatment that included a DAA
(direct-acting antiviral) NS3/4A protease inhibitor, NS5A inhibitor
and/or NS5B polymerase inhibitor.
About AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) in
Japan
MAVIRET™ is approved by the Japanese Ministry of Health, Labour
and Welfare (MHLW) for the treatment of chronic hepatitis C virus
(HCV) infection in adults across all major genotypes (GT1-6).
MAVIRET™ is a pan-genotypic, once-daily, ribavirin-free treatment
that combines glecaprevir (100mg), an NS3/4A protease inhibitor,
and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as
three oral tablets.
In Japan, MAVIRET™ is an 8-week treatment option for GT1 and GT2
HCV infected patients without cirrhosis and who are new to DAA
(direct-acting antiviral) treatment,* who comprise the majority of
people living with HCV in Japan. MAVIRET™ is the only pan-genotypic
treatment approved for use in patients across all stages of chronic
kidney disease. MAVIRET™ is also a 12-week option for patients
infected with GT3-6, patients with specific treatment challenges
including patients with compensated cirrhosis, and those with
limited treatment options such as those not cured with previous DAA
treatment.1
About Enanta
Enanta Pharmaceuticals has used its robust, chemistry-driven
approach and drug discovery capabilities to become a leader in the
discovery of small molecule drugs for the treatment of viral
infections and liver diseases. Two protease inhibitors,
paritaprevir and glecaprevir, discovered and developed through
Enanta’s collaboration with AbbVie, have now been approved in
jurisdictions around the world as part of AbbVie’s direct-acting
antiviral (DAA) regimens for the treatment of hepatitis C virus
(HCV) infection, including the U.S.-marketed regimens MAVYRET™
(glecaprevir/pibrentasvir) and VIEKIRA PAK®
(paritaprevir/ritonavir/ombitasvir/dasabuvir).
Royalties and milestone payments from the AbbVie collaboration
are helping to fund Enanta’s research and development efforts,
which 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). Please visit www.enanta.com for more information.
Forward Looking Statements
This press release contains forward-looking statements,
including statements with respect to the commercial prospects for
AbbVie’s MAVIRET regimen in Japan and globally. 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: Enanta’s revenues in the short-term are dependent
upon the success of AbbVie’s continuing commercialization efforts
for its new MAVYRET/MAVIRET regimen; competitive pricing, market
acceptance and reimbursement rates for MAVYRET/MAVIRET compared to
competitive HCV products on the market; Enanta’s and AbbVie’s need
to obtain and maintain patent protection for its HCV products 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 MAVIRET™ [package insert]. Tokyo, Japan: AbbVie Ltd.
2 Yu ML, Chuang WL. Treatment of chronic hepatitis C in Asia:
when East meets West. J Gastroenterol Hepatal.
2009;24(3):336-45.
3 Liu GG, DiBonaventura M, Yuan Y, et al, The burden of illness
for patients with viral hepatitis C: evidence from a national
survey in Japan. Value Health. 2012;15(1 Suppl):565-71.
4 Yatsuhashi, H. Past, Present, and Future of Viral Hepatitis C
in Japan. Euroasian Journal of Hepato-Gastroenterology 6, 49-51
(2016).
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version on businesswire.com: http://www.businesswire.com/news/home/20171130005534/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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