Jazz Pharma’s $1B bet pays off with accelerated lung cancer approval
Jazz Pharmaceuticals’ $1 billion bet last year looks to be paying off so far: for them and their partner.
Seven months after the Irish biopharma licensed PharmaMar’s small cell lung cancer drug lurbinectedin, the FDA has granted it accelerated approval. The drug, which was submitted two days before Jazz signed on in December and later granted priority review, will be marketed as Zepzelca.
Zepzelca won’t enter the market until July, at which point Jazz will face the difficult hurdles of commercializing a drug in a pandemic, but the approval should trigger an immediate payoff for PharmaMar. Although the exact terms aren’t spelled out, the original licensing agreement included “up to $250 million upon the achievement of accelerated and/or full regulatory approval of lurbinectedin by FDA within certain timelines.” That deal also included $200 million upfront and $550 million in commercial milestones.
It’s a bit of redemption for the Spanish biopharma. Originally founded in 1986 and later responsible for the sarcoma drug Yondelis, PharmaMar’s stock crashed in 2018 after Zepzelca failed in a late-stage ovarian cancer study.
Still, that left a pair of trials on small cell lung cancer. And at ASCO in 2019, PharmaMar announced the Phase II study had shown a 35.2% overall response rate as a second-line therapy — and 45% for the cohort they determined most sensitive to treatment. Those patients saw a progression-free survival of 4.6 months and an overall survival of 11.9 months.
That may not translate into accelerated approval for every indication, but small cell lung cancer has for years been a difficult field for drug development. Before 2018, when Bristol Myers Squibb’s immunotherapy Opdivo was approved for third-line patients, no drug had been approved for the tumor type in over a decade, according to the Lung Cancer Research Foundation. Since then, Keytruda won approval as a third-line treatment, and Tecentriq and Imfinzi were cleared as a first-line therapies.
This is Jazz’s second approval in a little over a year, after their follow-on narcolepsy drug Sunosi was OK’ed last March. It is their third cancer approval. Accelerated approvals can be contingent on a confirmatory trial, and a Phase III study is already underway.