Enanta Pharmaceuticals Provides Update on its Collaboration Agreement with AbbVie
October 20 2014 - 4:52PM
Business Wire
- Co-Development Option on
Next-Generation Protease Inhibitor ABT-493 Not Exercised
- Net Sales Allocations for
ABT-450-Containing Regimens Finalized
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 it has decided not to exercise its co-development
option for ABT-493, Enanta’s next-generation protease inhibitor for
hepatitis C virus (HCV) being developed in Enanta’s collaboration
with AbbVie. Per the original collaboration agreement signed in
December 2006, Enanta will be eligible for certain regulatory
approval milestones as well as royalties on net sales allocable to
ABT-493 from worldwide sales of any ABT-493-containing regimens.
Enanta also announced that it has reached agreement with AbbVie
regarding the net sales allocations for royalty calculations for
ABT-450-containing regimens, as well as any regimens containing
ABT-493. ABT-450 is the first clinical-stage protease inhibitor
candidate developed within the Enanta-AbbVie collaboration, and
ABT-493 is the second.
“We believe that the development and commercialization of our
HCV protease assets, ABT-450 and ABT-493, are in good hands with
the expertise and resources of a global biopharmaceutical company
such as AbbVie,” stated Jay R. Luly, Ph.D., President and CEO. “At
this time, we have decided it is better to use our financial
resources generated by these partnered assets to advance our other
internal proprietary candidates for HCV, including our newly
reacquired NS5A program, and to pursue the growth of our pipeline
beyond HCV with additional candidates in infectious disease and
other indications.”
Net Sales Allocations for Protease-Inhibitor-Containing
Regimens Used to Calculate Annual RoyaltiesUnder the original
agreement with AbbVie, Enanta is entitled to receive payments for
regulatory and reimbursement approval milestones, as well as
annually tiered royalties per product, ranging from the low double
digits up to twenty percent, on AbbVie’s worldwide net sales
allocable to the collaboration’s protease inhibitor product. With
the amended agreement, the following percentages of worldwide net
sales of ABT-450-containing regimens will be the net sales then
used to calculate annual royalties payable to Enanta:
Protease
Inhibitor-ContainingRegimens
Percentage of Annual NetSales
Used for EnantaRoyalty Calculation
ABT-450-containing 3-DAA regimen(ABT-450/r, ombitasvir and
dasabuvir) 30% ABT-450-containing 2-DAA
regimen(ABT-450/r, ombitasvir) 45%
For any HCV treatment regimen containing
ABT-493, net sales forroyalty purposes will be determined by
dividing AbbVie’s worldwidenet sales of the regimen by the number
of DAAs in the regimen (e.g.50% of net sales for a 2-DAA regimen
and33 1/3% of net sales for a 3-DAA regimen).
In addition, although ABT-493 is not currently being developed
for sale in combination with any active ingredient other than a
DAA, if it were, then there would be a further adjustment to net
sales of the regimen for royalty purposes based on the relative
value of any non-DAA in the regimen sold by AbbVie.
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 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 $95 million in subsequent clinical and
regulatory milestone payments, and is eligible to receive up to an
additional $155 million in payments for regulatory and
reimbursement approval milestones, as well as annually tiered,
double-digit royalties per product on AbbVie’s worldwide net sales
allocable to the collaboration’s protease inhibitors.
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, 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 DisclaimerThis press release
contains forward-looking statements, including with respect to the
prospects for commercialization of ABT-450-containing regimens, net
sales allocations for annual royalty purposes for any future
worldwide net sales of ABT-450-containing regimens or
ABT-493-containing regimens, and the prospects for the growth of
Enanta’s research pipeline in HCV and beyond HCV. 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 development and
commercialization efforts of AbbVie (our collaborator on ABT-450
and ABT-493), regulatory actions affecting approvals of
ABT-450-containing regimens and approvals of competitive product
candidates in HCV, risks associated with trying to discover new
product candidates, and other risk factors described or referred to
in “Risk Factors” in Enanta’s most recent Annual Report on Form
10-K for the fiscal year ended September 30, 2013 and in other
periodic reports filed with the Securities and Exchange Commission.
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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