Enanta Announces European Commission Grants
Marketing Authorizations for AbbVie’s VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) for the Treatment of Genotypes 1 and 4 Chronic Hepatitis C
Virus
- VIEKIRAX® contains Enanta’s lead
protease inhibitor, paritaprevir (formerly ABT-450)
- All-oral, interferon-free regimen also
approved for HCV/HIV-1 co-infection, patients on opioid
substitution therapy and patients who have undergone a liver
transplant1,2
- VIEKIRAX + EXVIERA are the first
products to be approved as a combination treatment of three
direct-acting antivirals with distinct mechanisms of action
targeting HCV at multiple steps in the viral lifecycle1,2
- In phase 3 clinical trials, VIEKIRX +
EXVIERA cured 95-100 percent of hepatitis C patients, with less
than 2 percent of patients experiencing virologic failure1,2
- Tolerability profile shows more than 98
percent of patients completed a full course of therapy3
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 the European Commission has granted marketing
authorizations for AbbVie’s VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets)1,2 with or without ribavirin (RBV) for the treatment of
patients with genotype 1 (GT1) chronic hepatitis C virus (HCV)
infection, including those with compensated liver cirrhosis, HIV-1
co-infection, patients on opioid substitution therapy and liver
transplant recipients.1,2 The European Commission has also approved
VIEKIRAX for use with RBV for the treatment of patients with
genotype 4 (GT4) chronic HCV infection.1
Paritaprevir (formerly known as ABT-450) is Enanta’s lead
protease inhibitor identified within the ongoing Enanta-AbbVie
collaboration and is one of two direct-acting antivirals (DAAs) in
the VIEKIRAX tablet. AbbVie is responsible for all worldwide
development and commercialization of VIEKIRAX-containing regimens
and other regimens containing paritaprevir. Enanta is entitled to a
$50 million milestone payment from AbbVie upon commercial
regulatory approval of VIEKIRAX in Europe.
“We are pleased that paritaprevir will now be available in
Europe as well as in the U.S. as part of AbbVie’s HCV treatment
regimen to help patients suffering from HCV,” stated Jay R. Luly,
Ph.D. President and CEO. “With these approvals, in addition to a
treatment for genotype 1 HCV patients, there is now a treatment for
genotype 4 HCV patients in Europe as well.”
The approvals follow a review under accelerated assessment by
the European Medicines Agency designated to new medicines of major
public health interest. AbbVie’s HCV treatment regimens are now
licensed for use in all 28 member countries of the European Union,
as well as in the U.S., Canada, Switzerland, Iceland, Liechtenstein
and Norway. Approximately nine million people in Europe are
infected with chronic HCV, a major cause of liver cancer and liver
transplantation.4 Genotype 1 is the most prevalent form of HCV in
Europe, and it accounts for 60 percent of cases worldwide.5 In
Europe, the most prevalent sub-genotype is 1b (47 percent).6
Genotype 4, 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.7
Clinical Development Program for VIEKIRAX® + EXVIERA®
The approval of VIEKIRAX + EXVIERA is supported by a robust
clinical development program designed to study the safety and
efficacy of the regimen in more than 2,300 enrolled patients across
25 countries.1,2 The program consisted of six pivotal Phase 3
studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100
percent of hepatitis C patients with GT1 HCV infection who received
the recommended regimen, with less than 2 percent of patients
experiencing virologic failure.1,2 Additionally, more than 98
percent (n=2,011/2,053) of patients in clinical trials completed a
full course of therapy.3 Most common (>20 percent) adverse
reactions for VIEKIRAX + EXVIERA with RBV were fatigue and
nausea.1,2
The approval of VIEKIRAX + EXVIERA is also based on the results
from Phase 2 clinical trials in GT1 chronic HCV infected patients,
which showed that VIEKIRAX + EXVIERA cured 97 percent (n=33/34) of
liver transplant recipients, 92 percent (n=58/63) of patients
co-infected with HIV-1 and 97 percent (n=37/38) of patients on
opioid substitution therapy.1,2 Patients who achieve a sustained
virologic response (SVR12) are considered cured of hepatitis C.
Approval of VIEKIRAX in GT4 chronic hepatitis C was based on a
Phase 2 study in which patients treated with VIEKIRAX with RBV
achieved 100 percent SVR12.1
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved for the treatment of genotype 1
chronic hepatitis C virus (HCV) infection, including patients with
compensated cirrhosis. VIEKIRAX consists of the fixed-dose
combination of paritaprevir 150mg (NS3/4A protease inhibitor) and
ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once
daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B
polymerase inhibitor) dosed twice daily taken with or without
ribavirin, dosed twice daily. VIEKIRAX + EXVIERA is taken for 12
weeks with or without RBV, except in GT1a patients with cirrhosis,
who should take it for 24 weeks.
For the treatment of genotype 4 chronic HCV patients, AbbVie’s
treatment consists of VIEKIRAX dosed once daily taken with RBV,
dosed twice daily.
EU Indication
VIEKIRAX is indicated in combination with other medicinal
products for the treatment of chronic hepatitis C (CHC) in adults.
EXVIERA is indicated in combination with other medicinal products
for the treatment of chronic hepatitis C (CHC) in adults.
IMPORTANT EU SAFETY INFORMATION FROM ABBVIE
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe
hepatic impairment (Child-Pugh C). Patients taking ethinyl
estradiol-containing medicinal products must discontinue them and
switch to an alternative method of contraception prior to
initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain
drugs that are sensitive CYP3A substrates or strong inhibitors of
CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate
enzyme inducers. Do not give EXVIERA with certain drugs that are
strong or moderate inducers of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX + EXVIERA are not recommended as monotherapy and should
be used in combination with other medicinal products for the
treatment of hepatitis C infection.
Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin,
women of childbearing potential or their male partners must use an
effective form of contraception during the treatment and 6 months
after the treatment. Refer to the Summary of Product
Characteristics for ribavirin for additional information.
ALT elevations
Transient elevations of ALT to >x5 ULN without concomitant
elevations of bilirubin occurred in clinical trials with VIEKIRAX +
EXVIERA and more frequent in a subgroup who were using
ethinylestradiol-containing contraceptives.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or
other glucocorticoids that are metabolized by CYP3A4. A reduction
in colchicine dosage or interruption in colchicine is recommended
in patients with normal renal or hepatic function. VIEKIRAX with or
without EXVIERA is expected to increase exposure of statins so
certain statins need to be discontinued or dosages reduced. Low
dose ritonavir, which is part of VIEKIRAX, may select for PI
resistance in HIV co-infected patients without ongoing
antiretroviral therapy. HIV co-infected patients without
suppressive antiretroviral therapy should not be treated with
VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX +
EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at
www.ema.europa.eu.
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
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
(ABT-450) and ABT-493 are protease inhibitors identified through
the collaboration. Under the agreement, AbbVie is responsible for
all development and commercialization activities for the
collaboration’s lead compound, paritaprevir, as well as ABT-493,
the collaboration’s next-generation protease inhibitor.
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. 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 Disclaimer
This press release contains forward-looking statements,
including with respect to the prospects for milestone and royalty
payments to Enanta related to the European Commission approval of
AbbVie’s paritaprevir-containing VIEKIRAX and Enanta’s prospects
for its continued pursuit of other potential drugs. 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
commercialization efforts of AbbVie (our collaborator on
paritaprevir) regarding treatment regimens containing paritaprevir,
market acceptance of those regimens, the impact of competitive
products on the use and sales of those regimens, and regulatory
actions affecting clinical development of paritaprevir and clinical
development of competitive product candidates. 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 VIEKIRAX™ tablets (ombitasvir/paritaprevir/ritonavir) Summary
of product characteristics. Maidenhead, UK. AbbVie, Ltd.
2 EXVIERA™ tablets (dasabuvir) Summary of product
characteristics. Maidenhead, UK. AbbVie, Ltd.
3 AbbVie data on file
4 Hatzakis A. et al. The state of hepatitis B and C in Europe:
report from the hepatitis B and C summit conference. Journal of
Viral Hepatitis, 2011; 18 (Suppl. 1): 1–16
5 Global Alert and Response (GAR): Hepatitis C. World Health
Organisation Web site.
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV.
Published 2003. Accessed November, 2013
6 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
7 Khattab MA, et al. Management of hepatitis C virus genotype 4:
Recommendations of an International Expert Panel. J Hepatol. 2011;
54: 1250–1262
InvestorEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMediaMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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