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 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.
Contacts:
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact
MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com