- Final decision from the European
Commission expected in the first quarter of 2015
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and
development-focused biotechnology company dedicated to creating
small molecule drugs primarily in the infectious disease field,
today announced that the European Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
granted positive opinions for AbbVie’s investigational, all-oral,
interferon-free treatment of VIEKIRAX™ (a combination of
ombitasvir, paritaprevir (ABT-450) and ritonavir) plus EXVIERA™
(dasabuvir), with or without ribavirin (RBV), for patients with
genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, and
VIEKIRAX™ only, with RBV, for patients with genotype 4 (GT4) HCV
infection. AbbVie anticipates that the European Commission will
review the opinions and make a final decision sometime in the first
quarter of 2015.
Paritaprevir is the generic name for ABT-450, an NS3/4A protease
inhibitor that is Enanta’s lead HCV candidate discovered during the
ongoing collaboration between AbbVie and Enanta for HCV protease
inhibitors and regimens that include protease inhibitors.
The combination of three direct-acting antivirals (3-DAA)
consisting of VIEKIRAX™ + EXVIERA™ is being investigated for the
treatment of genotype 1 chronic HCV infection, including patients
with compensated cirrhosis. VIEKIRAX™ consists of the fixed-dose
combination of paritaprevir 150mg and ritonavir 100mg with
ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
consists of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor), dosed twice daily with or without ribavirin.
For genotype 4 chronic HCV patients, AbbVie’s treatment is a
combination of two direct-acting antivirals (2-DAA) consisting of
VIEKIRAX™, dosed once daily, plus ribavirin, dosed twice daily.
“These positive opinions are an important step in bringing to
market a potential new cure for patients living with hepatitis C
virus,” stated Jay R. Luly, Ph.D, President and CEO. “We are
thrilled that our protease inhibitor paritaprevir is part of such
an important regimen and look forward to the European Commission’s
final decision anticipated in the first quarter of 2015.”
The marketing authorization applications (MAAs) for these
regimens were submitted to the EMA on May 6, 2014 under an
accelerated assessment, designated to new medicines of major public
health interest. Review of the MAAs is being conducted under the
centralized licensing procedure, which if approved will result in
marketing authorizations valid in all 28 member states of the
European Union, as well as Iceland, Liechtenstein and Norway.
The positive CHMP opinions are supported by a robust clinical
development program consisting of six pivotal Phase 3 studies –
SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV, and
TURQUOISE-II.1,2,3,4,5 AbbVie’s treatment regimen was evaluated in
more than 2,300 GT1 patients in over 25 countries. In addition, the
positive opinions were supported by a Phase 2 study, PEARL-I, in
GT4 patients without cirrhosis6 , as well as preliminary data from
the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients7
and from the CORAL-I study in liver transplant recipients with
recurrent GT1 HCV infection patients new to treatment after
transplantation.8
AbbVie estimates that approximately nine million people in
Europe are infected with HCV, which over time may lead to cirrhosis
and liver failure in about 10-20 percent of people with chronic
HCV.9,10 GT1 is the most common type of HCV genotype9, accounting
for 60 percent of cases worldwide. In Europe, the most prevalent
genotype is 1b (47 percent).11 GT4, most common in the Middle East,
sub-Saharan Africa and Egypt, is becoming increasingly prevalent in
several European countries including Italy, France, Greece and
Spain.12
The U.S. Food and Drug Administration (FDA) granted priority
review for AbbVie’s investigational 3-DAA treatment regimen for
patients with GT1 chronic HCV infection on June 13, 2014. The
regimen was also granted Breakthrough Therapy designation by the
FDA, a status given to investigational treatments for serious or
life-threatening conditions with preliminary clinical evidence
demonstrating substantial improvement on at least one clinically
significant endpoint compared to available therapy.
About Paritaprevir (ABT-450) Development
Paritaprevir, Enanta’s lead HCV candidate formerly known as
ABT-450, was discovered during the ongoing collaboration between
AbbVie and Enanta for HCV protease inhibitors and regimens that
include protease inhibitors. Paritaprevir is being developed by
AbbVie in a two-direct-acting-antiviral (2-DAA) treatment regimen
and a 3-DAA treatment regimen for HCV. The investigational,
all-oral, 2-DAA regimen consists of a fixed-dose combination of
paritaprevir/ritonavir (150/100mg) co-formulated with ombitasvir
(25mg), dosed once daily, co-administered with or without
weight-based ribavirin (1000mg or 1200mg in divided doses twice
daily). The investigational, all-oral, 3-DAA regimen consists of
the fixed-dose combination of paritaprevir/ritonavir (150/100mg)
co-formulated with ombitasvir (25mg), dosed once daily, plus
dasabuvir (250mg) with or without ribavirin, dosed twice daily.
Applications for approval of paritaprevir as part of a multi-drug
regimen were accepted for review in the United States and the
European Union in the second quarter of 2014.
Protease Inhibitor Collaboration with AbbVie
In 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. Under the agreement, AbbVie is now responsible for
all development and commercialization activities for the
collaboration’s lead compound, paritaprevir, as well as ABT-493.
Enanta has received $152 million in connection with the
collaboration agreement to date, (excluding research funding) and
is eligible to receive payments for commercial regulatory approval
milestones up to $155 million and $80 million for paritaprevir and
ABT-493, respectively, as well as annually tiered, double-digit
royalties per product on AbbVie’s worldwide net sales allocable to
any of the collaboration’s protease inhibitors.
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 primarily in the infectious disease field. 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. Additionally, Enanta
has a Bicyclolide antibiotic in early clinical development with the
National Institute of Allergy and Infectious Diseases (NIAID) for
the potential treatment of multi-drug resistant bacterial
infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the timing and prospects for
approval of AbbVie’s HCV treatment regimens containing paritaprevir
for use in Europe. Statements that are not historical facts are
based on Enanta’s 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 actions of AbbVie (our
collaborator on paritaprevir) regulatory and reimbursement actions
affecting any paritaprevir-containing regimen, and other risk
factors described or referred to in “Risk Factors” in Enanta’s most
recent Annual Report on Form 10-K for the fiscal year ended
September 30, 2013 and in other periodic reports filed 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 Feld JJ, Kowdley KV, Coakley E et al. Treatment of HCV with
ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med.
2014; 370: 1594-1603
2 Zeuzem S, Jacobson IM, Baykal T et al. Retreatment of HCV with
ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med.
2014; 370:1604-1614
3 Andreone P, Colombo MG, Enejosa JV et al. ABT-450, Ritonavir,
Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic
Response With or Without Ribavirin in Treatment-Experienced
Patients With HCV Genotype 1b Infection. Gastroenterology. 2014
Aug;147(2):359-365
4 Ferenci P, Bernstein D, Lalezari J et al. ABT-450/r–Ombitasvir
and Dasabuvir with or without Ribavirin for HCV. N Engl J Med.
2014; 370:1983-1992
5 Poordad F, Hezode C, Trinh R et al. ABT-450/r–Ombitasvir and
Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J
Med. 2014; 370: 1973-1982
6 Pol S, et al. Interferon-Free Regimens of Ombitasvir and
ABT-450/r With or Without Ribavirin in Patients With HCV Genotype 4
Infection: PEARL-I Study Results. Hepatology. 2014: vol. 60, no. 4
supplement:1129A
7 Wyles D, Sulkowski M, Eron J, et al. TURQUOISE-I: 94% SVR12 in
HCV/HIV-1 co-infected patients treated with ABT-450/r/ombitasvir
and dasabuvir and ribavirin. Presented at the 65th Annual Meeting
of the American Association for the Study of Liver Diseases (The
Liver Meeting 2014), November 7–11, 2014, Boston, MA. Poster
#1939
8 Kwo P, Mantry P, Coakley E, et al. An interferon-free
antiviral regimen for HCV after liver transplantation. N Engl J
Med. 2014; 1-8. doi: 10.1056/NEJMoa1408921
9 European Association for the Study of the Liver. Clinical
Practice Guidelines: Management of hepatitis C virus infection. J
Hepatol. 2014; 60: 392-420
10 Global Alert and Response (GAR): Hepatitis C. World Health
Organization Web site.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV.
Published 2003. Accessed December 2014
11 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
12 Khattab MA, et al. Management of hepatitis C virus genotype
4: Recommendations of an International Expert Panel. J Hepatol.
2011; 54: 1250–1262
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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