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 Royalties
Under 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-Containing | Percentage of Annual Net | ||
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 for |
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 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 $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 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, 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 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.
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