Enanta Pharmaceuticals, Inc., 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
Regimens Sales Used for Enanta
Royalty Calculation
ABT-450-containing 3-DAA regimen 30%
(ABT-450/r, ombitasvir and dasabuvir)
ABT-450-containing 2-DAA regimen 45%
(ABT-450/r, ombitasvir)
For any HCV treatment regimen containing ABT-493, net sales for
royalty purposes will be determined by dividing AbbVie's worldwide
net sales of the regimen by the number of DAAs in the regimen (e.g.
50% of net sales for a 2-DAA regimen and
33 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.
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