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June 13 2014 - 3:39PM
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 the New Drug Application (NDA) for AbbVie’s
investigational, all-oral, interferon-free regimen for the
treatment of adult patients with chronic genotype 1 (GT1) hepatitis
C virus (HCV) infection has been accepted by the U.S. Food and Drug
Administration (FDA) and has been granted priority review.
The three direct-acting antiviral investigational regimen
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.
The NDA was submitted on April 21, 2014 and is supported by data
from a large clinical program being conducted by AbbVie, including
six phase 3 studies of more than 2,300 GT1 patients in over 25
countries. The regimen was granted a Breakthrough Therapy
designation by the FDA in May 2013, 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.
In May 2014, AbbVie submitted marketing authorization
applications (MAAs) for regulatory approval in the European
Union.
In addition, Enanta confirmed that in the quarter ending June
30, 2014 it has now received from AbbVie milestone payments
totaling $40 million related to these regulatory filings.
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. 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-450ABT-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 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 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 DisclaimerThis 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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