Dive Brief:
- Jazz Pharmaceuticals, best known for its narcolepsy drugs, is joining many of its industry peers in staking its future to oncology, announcing Thursday a licensing deal that gives it access to a near-market lung cancer drug.
- Jazz will pay $200 million upfront to Spanish drugmaker PharmaMar for U.S. commercial rights to lurbinectedin, a therapy the Food and Drug Administration is now reviewing for accelerated approval in relapsed small-cell lung cancer. The deal could be worth another $800 million in potential milestones for PharmaMar.
- Bruce Cozadd, the Irish biopharma's longtime CEO, called the drug "a strong strategic fit" for Jazz's oncology portfolio, which has expanded over the past decade and now contains more than 10 hematology-oncology programs.
Dive Insight:
While Jazz still makes most of its money from the blockbuster narcolepsy treatment Xyrem (sodium oxybate), the company's oncology presence has grown over the past decade to account for the vast majority of the biopharma's pipeline.
Adding in lurbinectedin, Jazz's pipeline includes 30 programs ranging from preclinical to Phase 3 testing. Four are in neuroscience or sleep, while the other 26 are listed under hematology-oncology.
That focus is also reflected in Jazz's decision to bring in a cancer research veteran to lead R&D for the $8.5 billion biopharma. Robert Iannone joined in May as executive vice president of R&D following previous stints as chief medical officer of Immunomedics, head of immuno-oncology for AstraZeneca and section head of oncology clinical development at Merck & Co.
With Thursday's deal, Jazz is acquiring U.S. rights to what appears to be a potentially promising treatment in an aggressive, hard-to-treat type of cancer.
PharmaMar submitted a New Drug Application on Tuesday for accelerated approval in relapsed small-cell lung cancer. That application is supported by data from roughly 100 patients tested in a Phase 2 trial, which showed treatment shrank tumors in 35% of patients.
The company has compared that figure to the 17% response rate seen with a chemotherapy commonly used in small-cell lung cancer.
But this year has featured other approvals for the hard-to-treat lung cancer, including for two leading immunotherapies. Merck's Keytruda (pembrolizumab) is now approved as a third-line treatment for metastatic cases and Roche's Tecentriq (atezolizumab) gained a first-line OK in combination with chemotherapy for extensive-stage patients.
Bristol-Myers Squibb's Opdivo (nivolumab) also gained a third-line approval in 2018, although follow-up trial results found the drug did not improve survival.
Both Keytruda and Opdivo won third-line accelerated approvals with response rates of 19% and 12%, respectively. (PharmaMar's drug was tested in an earlier line of patients, who hadn't already failed a second therapy in addition to chemotherapy.)
Per deal terms, Jazz will pay an additional $250 million if the FDA approves lurbinectedin by an unspecified date. The pharma also committed $550 million in commercial milestone payments to go along with incremental royalty payments that range from the high teens to 30%.
Jazz's stock was up nearly 2% Thursday morning and has risen nearly 20% in 2019.