Enanta Pharmaceuticals Announces European Medicines Agency Validates Marketing Authorization Applications for AbbVie’s Inve...
June 17 2014 - 2:03AM
Business Wire
Regimen Contains Protease Inhibitor ABT-450
from Enanta/AbbVie Collaboration
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs in the infectious disease field, today
announced that AbbVie has reported that the Marketing Authorization
Applications (MAAs) for AbbVie’s investigational, all-oral,
interferon-free regimen primarily for the treatment of adult
patients with chronic genotype 1 (GT1) hepatitis C virus (HCV)
infection have been fully validated and are now under accelerated
assessment by the European Medicines Agency (EMA).
The three direct-acting antiviral investigational regimen for
GT1 consists of the fixed-dose combination of ABT-450/ritonavir
(150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed
once daily, and dasabuvir (ABT-333) 250mg with or without ribavirin
(weight-based), dosed twice daily. ABT-450 is Enanta’s lead
protease inhibitor developed through Enanta’s collaboration with
AbbVie.
Accelerated assessment, which is a review process designated for
new medicines of major public health interest, was granted in May
2014 by the EMA for AbbVie’s investigational HCV regimen.
Validation of the MAAs confirms that the submissions are complete
and starts the EMA's centralized review process. If approved,
AbbVie expects that its regimen could be available for marketing in
the European Union in the first quarter of 2015.
The MAAs were submitted on May 8, 2014 and are supported by data
from a large clinical program conducted by AbbVie, including six
phase 3 studies of more than 2,300 GT1 patients in over 25
countries. Review of the MAAs will be conducted under the
centralized licensing procedure, which, when finalized, provides
marketing authorizations in all 28 member states of the European
Union.
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. ABT-450 is a
protease inhibitor identified as a lead compound through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for ABT-450. Enanta
received $57 million in connection with signing the collaboration
agreement, has received $95 million in subsequent clinical and
regulatory milestone payments (including $40 million in connection
with the MAA and FDA filings for the regimen described above), and
is eligible to receive up to an additional $155 million in payments
for regulatory and reimbursement approval milestones, as well as
double-digit royalties worldwide on any revenue allocable to the
collaboration’s protease inhibitors. Also, for any additional
collaborative HCV protease inhibitor product candidate developed
under the agreement, Enanta holds an option to modify the U.S.
portion of it rights to receive milestone payments and worldwide
royalties. With this option, Enanta can fund 40 percent of U.S.
development costs and U.S. commercialization efforts (sales and
promotion costs) for the additional protease inhibitor in exchange
for 40 percent of any U.S. profits ultimately achieved after
regulatory approval, instead of receiving payments for U.S.
commercial regulatory approval milestones and royalties on U.S.
sales of that protease inhibitor.
About ABT-450
ABT-450 is an NS3 protease inhibitor discovered through Enanta’s
ongoing collaboration with AbbVie. AbbVie and Enanta have an
agreement to collaborate on the discovery, development and
commercialization of HCV NS3 and NS3/4A protease inhibitors.
Protease inhibitors play an essential role in the viral life cycle
of the hepatitis C virus (HCV). Inhibition of the protease prevents
non-structural (NS) proteins from forming and thereby prevents
replication and survival of the HCV virus. ABT-450 is part of
AbbVie’s investigational regimen for HCV that consists of boosted
protease inhibitor ABT-450/ritonavir (referred to as ABT-450/r),
NS5A inhibitor ABT-267 and non-nucleoside polymerase inhibitor
ABT-333.
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 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 (partnered with Novartis) and
nucleotide polymerase – as well as a host-targeted antiviral (HTA)
inhibitor class targeted against cyclophilin. Additionally, Enanta
has created a new class of antibiotics, called Bicyclolides, for
the treatment of multi-drug resistant bacteria, with a focus on
developing an intravenous and oral treatment for hospital and
community MRSA (methicillin-resistant Staphylococcus aureus)
infections.
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for AbbVie’s HCV
treatment regimen containing ABT-450 for HCV and the prospects for
milestone payments and royalties to Enanta resulting from any
regulatory and reimbursement approvals of the regimen. 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 ABT-450) to obtain regulatory approvals
and commercialize treatment regimens containing ABT-450, the
development, regulatory and marketing efforts of others with
respect to competitive HCV treatment regimens, regulatory and
reimbursement actions affecting any ABT-450-containing regimen, any
competitive regimen, or both, and the level of market acceptance
and the pricing and rate of reimbursement for any
ABT-450-containing regimen. 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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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