Enanta Pharmaceuticals Announces Submission of EU Marketing Authorization Applications to the European Medicines Agency for All

  Enanta Pharmaceuticals Announces Submission of EU Marketing Authorization
  Applications to the European Medicines Agency for All-Oral, Interferon-Free
  Hepatitis C Regimen Containing ABT-450

              Submission Triggers $20 million Payment to Enanta

Business Wire

WATERTOWN, Mass. -- May 8, 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 AbbVie, Enanta’s collaboration
partner for ABT-450, has submitted Marketing Authorization Applications (MAA)
to the European Medicines Agency (EMA) seeking approval for its
investigational, all-oral, interferon-free regimen for the treatment of adult
patients infected with chronic genotype 1 (GT1) hepatitis C virus (HCV).

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 MAAs are supported by AbbVie’s data from the largest all-oral,
interferon-free clinical program conducted to date in GT1 patients.^1 It
includes data from six phase 3 studies involving more than 2,300 patients in
over 25 countries.

The European MAA submissions trigger a $20 million milestone payment to Enanta
from AbbVie.

“There are a significant number of patients infected in the EU with chronic
GT1 HCV for which this therapy could be beneficial,” said Jay R. Luly, Ph.D.,
Enanta’s President and Chief Executive Officer. “We look forward to the
potential approval of this therapy in the EU.”

Accelerated Assessment Granted

The EMA has granted AbbVie’s request for accelerated assessment for
ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333), a
designation that is granted to new medicines of major public health interest.
Review of AbbVie’s MAAs will be conducted under the centralized licensing
procedure which, when finalized, provides one marketing authorization in all
28 member states of the European Union (EU). If approved, AbbVie has indicated
that the ABT-450/ritonavir, ombitasvir (ABT-267) and dasabuvir (ABT-333)
regimen could be available for marketing in the EU in the first quarter of
2015.

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
$55 million in subsequent clinical milestone payments, is entitled to receive
$40 million in connection with the MAA filings in the European Union described
above and AbbVie’s recent FDA filing for the same regimen, 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 Statements Disclaimer

This press release contains forward-looking statements, including statements
with respect to the prospects for regulatory filings for AbbVie’s HCV
treatment regimen containing ABT-450 and the prospects for milestone payments
and royalties to Enanta resulting from such filings and any subsequent
regulatory and reimbursement approvals. 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 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.

^1 Comparison based on review of data from www.clinicaltrials.gov for phase 3a
programs of Gilead, BMS and BI as of November 15, 2013.

Contact:

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