On January 22, 2020 PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended "HSR", with respect to the exclusive license agreement for lurbinectedin in the United States expired as of January 21, 2020 at 11:59 p.m. ET (Press release, PharmaMar, JAN 22, 2020, View Source [SID1234553415]).
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As previously announced, on 19 December 2019, PharmaMar and Jazz Pharmaceuticals signed an exclusive license agreement for U.S. rights to lurbinectedin, the effectiveness of which was subject to the expiration or early termination of the applicable HSR waiting period. With the expiration of the HSR waiting period, the agreement became effective, and PharmaMar will receive the initial upfront payment of $200 million in the forthcoming days.
Under the terms of the agreement, PharmaMar is also eligible to receive, in the following months, potential regulatory milestone payments of up to $250 million upon the achievement of accelerated and/or full regulatory approval of lurbinectedin by FDA within certain timelines.
PharmaMar is also eligible to receive up to $550 million in potential commercial milestone payments, as well as incremental tiered royalties on future net sales of lurbinectedin ranging from the high teens up to 30%.
PharmaMar retains production rights for lurbinectedin and will supply the product to Jazz.
In December 2019, PharmaMar submitted an NDA to FDA for accelerated approval of lurbinectedin for relapsed SCLC, based on data from its Phase 2 basket trial, following positive interactions with FDA.
About Lurbinectedin
Lurbinectedin (PM1183) is a synthetic compound currently under clinical investigation. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.