Date: 2014-10-20
Type of information: Exercise of an option agreement
Compound: ABT-493
Company: Enanta Pharmaceuticals (USA - MA) Abbvie (USA - IL)
Therapeutic area: Infectious diseases
Type agreement:
Action mechanism:
Disease: hepatitis C
Details: * On October 20, 2014, Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, 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.
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.
Financial terms: 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 Regimens Percentage of Annual NetSales Used for Enanta Royalty Calculation ABT-450-containing 2-DAA regimen (ABT-450/r, ombitasvir) 45% For any HCV treatment regimen containing ABT-493, net sales for royalty purposes will be determined by dividing AbbVie’s worldwide
ABT-450-containing 3-DAA regimen (ABT-450/r, ombitasvir and dasabuvir) 30%
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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