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, Enanta’s development partner for protease inhibitors for
hepatitis C virus (HCV), has initiated a phase 2b clinical study with
ABT-493, Enanta’s next-generation protease inhibitor. ABT-493 is the
second clinical-stage protease inhibitor candidate developed within the
Enanta-AbbVie collaboration.
The phase 2b study being conducted by AbbVie will evaluate the safety
and efficacy of ABT-493 co-administered with ABT-530, AbbVie’s next
generation NS5A inhibitor, in HCV patients. AbbVie has informed Enanta
that results from this trial are expected in 2015 and AbbVie plans to
start phase 3 development of the combination next year. Additional
details regarding this study will be available when they are posted by
AbbVie at www.clinicaltrials.gov.
“The goal of our collaboration’s next-generation protease inhibitor
program is a pan-genotypic, ribavirin-free, once-daily dosing regimen
for HCV patients,” stated Jay R. Luly, Ph.D., President and CEO.
About ABT-493
ABT-493 is a next-generation HCV NS3/4A protease inhibitor identified
within the Enanta-AbbVie collaboration. Designed to enable once-daily
dosing without ritonavir, ABT-493 is expected to be co-formulated with
AbbVie’s next-generation NS5A inhibitor, ABT-530. Protease plays 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.
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 and ABT-493 are
protease inhibitors identified through the collaboration. Under the
agreement, AbbVie is responsible for all development and
commercialization activities for ABT-450, the collaboration’s lead
compound that has been submitted for approval in the United States and
the European Union as part of a multi-drug regimen. Enanta received $57
million in connection with signing the collaboration agreement and is
eligible to receive payments for regulatory and reimbursement approval
milestones, as well as tiered, double-digit royalties worldwide on any
revenue allocable to the collaboration’s protease inhibitors. Also, for
ABT-493 or any other additional collaborative HCV protease inhibitor
product candidate developed under the agreement, Enanta holds an option
to modify the U.S. portion of its rights to receive milestone payments
and worldwide royalties. If it exercises 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 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 potential of AbbVie’s HCV treatment
regimen containing ABT-493 and Enanta’s expectations for the timing of
future clinical development of such 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-493) to obtain regulatory
approvals and commercialize treatment regimens containing ABT-493, the
development, regulatory and marketing efforts of others with respect to
competitive HCV treatment regimens, regulatory and reimbursement actions
affecting any ABT-493-containing regimen, any competitive regimen, or
both, and the level of market acceptance and the pricing and rate of
reimbursement for any ABT-493-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.
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