PharmaMar (MSE: PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) state that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended “HSR,” concerning the particular license deal for lurbinectedin in the United States departed as of 21 January 2020 at 11:59 p.m. ET.
As previously stated, on 19 December 2019, PharmaMar and Jazz Pharmaceuticals hired an exclusive license contract for U.S. rights to lurbinectedin, the effectiveness of which was subject to the termination or early close of the relevant HSR waiting period. With the closing of the HSR waiting period, the contract became active, and PharmaMar will get the initial upfront payment of $200 million in the coming days.
Under the terms of the contract, PharmaMar is also likely to receive, in the coming months, reasonable administrative event payments of up to $250 million upon the completion of accelerated and comprehensive departmental approval of lurbinectedin by FDA (Food And Drug Administration) within specific timelines.
PharmaMar is also likely to support up to $550 million in potential sales milestone payments, as well as incremental tiered authorities on future net sales of lurbinectedin extending from the high teens up to 30%.
PharmaMar maintains production rights for lurbinectedin and will provide the product to Jazz.
In December 2019, PharmaMar offered an NDA to the FDA for accelerated permission of lurbinectedin for fallen SCLC, based on data from its Phase 2 basket trial, following certain communications with the FDA.
Lurbinectedin (PM1183) is a synthetic composite currently under clinical study. It is a particular inhibitor of the oncogenic transcription businesses on which many tumors are especially addicted. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the generation of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged point in those diseases, many of them lacking other actionable goals.
Headquartered in Madrid, PharmaMar is a biopharmaceutical firm focused on oncology and assigned to research and community, which takes its inspiration from the sea to create molecules with antitumor activity. It is a company that explores innovative results to provide healthcare specialists with new tools to treat cancer. Its dedication to patients and research has made it one of the world leaders in the development of antitumor drugs of marine origin.
PharmaMar has a pipeline of medicine applicants and a robust R&D oncology business. It develops and commercializes Yondelis® in Europe and has other clinical-stage plans under construction for several types of hard cancers: lurbinectedin (PM1183), PM184, and PM14.
With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria, and the United States. PharmaMar wholly owns other companies: GENOMIC, a molecular diagnostics company, Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi).
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical organization, is committed to developing life-changing medicines for people with limited or no benefits. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse collection of goods and product candidates in progress and is focused on transforming biopharmaceutical discoveries into novel drugs.
Jazz Pharmaceuticals markets Sunosi® (solriamfetol), Xyrem® (sodium oxybate) oral solution, Defitelio® (defibrotide sodium), Erwinaze® (asparaginase Erwinia chrysanthemi) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Sunosi, Defitelio® (defibrotide), Erwinase® and Vyxeos® liposomal 44 mg/100 mg powder for concentrate for suspension for infusion in countries outside the U.S.
PharmaMar Legal Statement
This press statement does not constitute an offer to sell or the solicitation of an offer to buy bonds. It shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful before certification or qualification under the safeguards laws of that jurisdiction.
This press release includes forward-looking charges, including, but not limited to, costs related to potential regulatory, sales, and development milestones under the licensing contract between Jazz Pharmaceuticals and PharmaMar and related possible future payments by Jazz Pharmaceuticals to PharmaMar; and other statements that are not actual realities.
These forward-looking comments are based on Jazz Pharmaceuticals’ current plans, objectives, estimates, expectations, and purposes and inherently involve significant risks and changes. Actual outcomes and the timing of events could differ substantially from those contemplated in such forward-looking reports as a result of these risks and uncertainties, which include, without limitation, dangers and difficulties connected with: pharmaceutical product promotion and clinical success thereof; the administrative approval process; finally commercializing any product competitors; and other risks and contingencies affecting Jazz Pharmaceuticals, including those described from time to time under the caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals plc’s Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company’s Quarterly Report on Form 10-Q for the quarter ended 30 September 2019 and future filings and statements by the company.
Other risks and possibilities of which Jazz Pharmaceuticals is not currently aware may also influence the company’s forward-looking comments. They may produce actual results and the timing of circumstances to differ substantially from those blocked. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the prospective charges, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise.
To Sum Up
Jazz Pharmaceuticals undertakes no responsibility to update or supplement any forward-looking costs to show actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking announcements were made.