Late last year, Jazz revealed it had agreed to pay PharmaMar $200m (€180m) upfront for exclusive US rights to lurbinectedin, a late-phase treatment for small cell lung cancer (SCLC). Jazz also committed up to $800m in milestones to secure the rights to the drug, which is designed to induce cell death by inhibiting activated transcription and inducing DNA double-strand breaks.
PharmaMar began 2019 by holding a conference call with investors to discuss the deal. Analysts used the call to question PharmaMar about the production of lurbinectedin and who will be responsible for what tasks.
Responding to an analyst question, Luis Mora, managing director of PharmaMar’s oncology business, said, “We will sell the active ingredient to Jazz Pharmaceuticals and then Jazz Pharmaceuticals will commercialize.”
Spain’s PharmaMar will carry out production activities at two facilities that Mora thinks have capacity to support commercialization of lurbinectedin.
PharmaMar looks to the sea for inspiration, leading it to base its one approved drug Yondelis (trabectedin) on a molecule produced by the sea squirt. However, lurbinectedin is made through a synthetic process.
The establishment of a process that starts with fermentation and runs through 18 synthesis steps has enabled PharmaMar to cost-effectively produce the drug to good manufacturing practice (GMP) standards.
Having done that, PharmaMar thinks it is well set to supply lurbinectedin in the quantities needed by Jazz.
Mora said, “We have sufficient raw materials, suppliers, et cetera, in order to be sure there’s not any issue about the commercial supply. The cost of the drug is not disclosed, obviously, but is highly cost efficient.”
How much lurbinectedin PharmaMar will need to make to meet demand is unclear at this stage. The Spanish drug developer filed for US Food and Drug Administration (FDA) approval late last year, putting it on track to gain clearance to sell lurbinectedin some time in 2020.
If approved, lurbinectedin could become the first new chemical entity authorized by the FDA in the treatment of SCLC in more than 20 years.
Since the approval of Hycamtin (topotecan) in the 1990s, Bristol-Myers Squibb and Merck have won approval for their checkpoint inhibitors Opdivo (nivolumab) and Keytruda (pembrolizumab), respectively, in SCLC. However, those drugs were already on the market in other indications at the time of the SCLC approvals and are only authorized in third-line settings. Lurbinectedin could come to market as a second-line treatment.