Enanta Pharmaceuticals Announces U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free

  Enanta Pharmaceuticals Announces U.S. FDA Grants Priority Review to AbbVie
  for Investigational, All-Oral, Interferon-Free Regimen for Genotype 1
  Chronic Hepatitis C

 Regimen Contains Protease Inhibitor ABT-450 from Enanta/AbbVie Collaboration

Business Wire

WATERTOWN, Mass. -- June 13, 2014

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.

Contact:

Investor Contact
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
 
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