Cubist Pharmaceuticals, Inc. (CBST) said it reached a license agreement with Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., which includes a stipulation by the parties requesting dismissal of the lawsuit filed by Cubist in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by TPM with the U.S. Food and Drug Administration for a generic version of CUBICIN.
Under the terms of the agreement, Teva may launch its generic daptomycin product in the U.S. on June 24, 2018, if Cubist obtains a 6 month extension of marketing exclusivity for CUBICIN under section 505A of the Food and Drug Administration Modernization Act. Otherwise, Teva may launch on December 24, 2017.
The agreement also provides that, for the period the license from Cubist to Teva is in effect, Teva would purchase its U.S. requirements of daptomycin exclusively from Cubist. The payments to be made to Cubist for such supply would have two components: one based on the cost-of-goods-sold plus a margin, and the other based on a specified percentage of gross margin from the sale of Teva's generic daptomycin.
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