Enanta Announces U.S. FDA Grants Priority Review for AbbVie’s Investigational, All-Oral, Interferon-Free Treatment Regimen ...
April 23 2015 - 8:16AM
Business Wire
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 AbbVie has stated that the U.S. Food and Drug
Administration (FDA) has accepted AbbVie’s New Drug Application
(NDA) and granted priority review for its all-oral,
interferon-free, two direct-acting antiviral (2-DAA) treatment
regimen consisting of the fixed-dose combination of ombitasvir,
paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV) for the
treatment of adult patients with chronic genotype 4 (GT4) hepatitis
C virus (HCV) infection.
The FDA grants priority review designation to investigational
therapies that treat a serious condition and, if approved, would
provide a significant improvement in safety or effectiveness.
AbbVie’s regimen was also granted a Breakthrough Therapy
designation by the FDA on June 30, 2014, a status given to
investigational treatments for serious or life-threatening
conditions with preliminary clinical evidence that may demonstrate
substantial improvement on at least one clinically significant
endpoint compared to available therapy.1
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
two DAAs in AbbVie’s treatment regimen included in the NDA for the
treatment of GT4 chronic hepatitis C patients. AbbVie is
responsible for all development and commercialization activities
for regimens that contain paritaprevir. Paritaprevir is included in
AbbVie’s GT1 HCV treatment regimens approved in the U.S. in late
2014 and in the E.U. in early 2015. 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.
The Centers for Disease Control and Prevention (CDC) estimates
that in the United States, 3.2 million people are chronically
infected with HCV.2 While genotype 1 (GT1) is the most prevalent
form of HCV in the U.S., accounting for approximately 73 percent of
all cases, GT4 infection accounts for up to 6 percent of HCV
infections in the U.S.3,4 Hepatitis C is inflammation of the liver
caused by an infection with the HCV virus.5 It is transmitted when
an infected person's blood enters the bloodstream of another
person.6 There are six major HCV genotypes (GT1-6).7 Presently,
there is no vaccine for HCV infection.4
Protease Inhibitor Collaboration with AbbVieIn 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 EnantaEnanta 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 DisclaimerThis press release
contains forward-looking statements, including with respect to the
prospects for AbbVie’s paritaprevir-containing regimens for
patients with GT4 HCV infection. 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 of regimens containing paritaprevir;
the level of market acceptance and the pricing and rate of
reimbursement for those regimens; the impact of competitive
products on the use and sales of those regimens; regulatory actions
affecting clinical development of competitive product candidates;
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 U.S. Food and Drug Administration Online. Fact Sheet:
Breakthrough Therapies.
http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm329491.htm.
Accessed March 20, 2015.
2 Centers for Disease Control and Prevention (CDC). Hepatitis C
FAQs for health professionals.
http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed March 10,
2015
3 O’Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS,
Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and
Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier. 2010:1313-1335.
4 Gower E, Estes C, Blach S, et al. Global epidemiology and
genotype distribution of the hepatitis C virus infection. J
Hepatology. 2014;61:S45-S57.
5 Mayo Clinic. Hepatitis C: Definition.
http://www.mayoclinic.org/diseases-conditions/hepatitis-c/basics/definition/con-20030618.
Accessed November 2013.
6 World Health Organization. Hepatitis C Fact Sheet 2014.
http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed April
2014.
7 AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and
treating hepatitis C. http://www.hcvguidelines.org. Accessed March
9, 2015.
InvestorCarol Miceli, 617-607-0710Enanta Pharmaceuticals,
Inc.cmiceli@enanta.comorMediaKari Watson,
781-235-3060MacDougall Biomedical
Communicationskwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Apr 2023 to Apr 2024