Cubist enters license agreement with Teva to dismiss CUBICIN patent lawsuit

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has entered into a license agreement with Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. (the Teva defendants), 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 (ANDA) filed by TPM with the U.S. Food and Drug Administration (FDA) for a generic version of CUBICIN® (daptomycin for injection).

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 of 1997 (pediatric exclusivity). Otherwise, Teva may launch on December 24, 2017. Teva will obtain such rights through the grant of a non-exclusive license from Cubist to Teva that would trigger on one of the dates set forth above. Cubist currently has Orange Book patents that are due to expire on September 24, 2019. Pediatric exclusivity, if granted, would add 6 months to that expiration date. In certain limited circumstances, Cubist's license to Teva would become effective prior to the dates set forth above.

The agreement also provides that, for the period the license from Cubist to Teva is in effect, Teva will 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 (referred to as net profit in the agreement) from the sale of Teva's generic daptomycin.

As part of the agreement announced today, Teva admits that the patents asserted in the lawsuit are valid and enforceable against, and would be infringed by, Teva's proposed generic daptomycin for injection product. The claims to be dismissed pursuant to the settlement agreement include Teva's allegation that two of Cubist's patents are unenforceable due to inequitable conduct.

Cubist President and CEO Mike Bonney said, "We are very pleased with this result, which reflects our continued confidence in the strength of our patents while removing the uncertainty, distraction and cost of litigation. We confirm today that we expect CUBICIN to achieve $1 billion in U.S. revenues before the anticipated entry of Teva's generic daptomycin in 6 ½ to 7 years. As Teva's exclusive supplier, we expect we will enhance our participation in the market for daptomycin through our latest to expire patent."

As required by law, Cubist and Teva will submit the Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice.