It has been publicized by Jazz Pharmaceuticals plc and PharmaMar that the waiting time under 1976’s Hart-Scott-Rodino Antitrust Improvements Act, as revised “HSR”, with respect to the license deal for lurbinectedin in the U.S. expired on the 21st of January of this year.
As publicized on the 19th of December of last year, Jazz Pharmaceuticals and PharmaMar entered into a license contract for the United States rights to lurbinectedin. The effectiveness of the contract was subject to expiration or premature termination of the applicable HSR waiting time. As the HSR waiting period expired, the contract became effective, and PharmaMar will be recipient to the first outright payment of $200 million in the upcoming days.
In an upcoming couple of months, as per the contract, the company is also set to receive possible regulatory milestone payments of as much as $250 million when it attains boosted and/or complete regulatory approval for lurbinectedin by FDA in a set time.
The company can also receive as much as $550 million in possible commercial milestone payments, along with incremental tiered royalties on the upcoming lurbinectedin sales going from the later teens and up to 30%.
The manufacture rights for lurbinectedin are held by PharmaMar, the company will supply it to Jazz.
In last year’s December, an NDA was submitted by PharmaMar to FDA to speed up the approval of lurbinectedin for relapsed SCLC.
Lurbinectedin is a man-made compound that is presently undergoing clinical examination. In addition to its impact on cancer cells, the compound also ceases, in tumor-associated macrophages, the oncogenic transcription. It downregulates the generation of cytokines which are vital for the tumor’s growth.
PharmaMar is a biological firm, its headquarters are situated in Madrid. The firm focuses on oncology and looks for innovative products to deliver healthcare experts with the newest tools for cancer treatment.