It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017.
The FDA has approved Onivyde as part of a multidrug combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer. Before Tuesday’s approval, Onivyde had been allowed for patients with previously treated disease since 2015.
Nalirifox marks the first new regimen approved specifically for first-line treatment of pancreatic cancer in more than 10 years, Julie Fleshman, CEO of the Pancreatic Cancer Action Network, said in a statement.
The new regimen pairs Onivyde with the chemotherapies oxaliplatin and fluorouracil, plus leucovorin. Onivyde, or liposomal irinotecan, essentially replaces the original form of irinotecan used in the older Folfirinox regimen.
Pancreatic cancer is notoriously difficult to treat. Although the Onivyde combo is far from a cure, it has proven to be able to extend patients’ lives.
In the NAPOLI 3 trial, Nalirifox cut the risk of death by 16% compared with the traditional chemo combination of Bristol Myers Squibb’s Abraxane and gemcitabine. Patients who received the Onivyde-containing regimen lived a median 11.1 months, versus 9.2 months in the control arm.
For most cancer therapies, a reduction in the risk of death that’s less than 20% is typically considered not meaningful. But in the case of Nalirifox in pancreatic cancer, the 16% improvement was statistically significant and strong enough to win an FDA approval.
Nalirifox also pared down the risk of tumor progression or death by 30% compared with the traditional chemo combo. It triggered a 41.8% response rate, slightly better than the 36.2% observed in the control arm.
Based on the data, analysts project Onivyde’s sales will grow to 265 million euros in 2025, versus 164 million euros in 2023, according to an ODDO BHF note from last week. Ipsen itself believes the drug could eventually reach 500 million euros in peak sales by growing its share in both the front-line and post-chemo settings, a company spokesperson told Fierce Pharma.
The first-line nod should also contribute to Ipsen’s recently announced goal to grow sales by at least 7% annually between 2023 and 2027 at constant exchange rates. In 2023, the French pharma pulled in 3.13 billion euros, an increase of 6.7% at unchanged currencies.
Ipsen purchased Onivyde from Cambridge, Massachusetts-based Merrimack Pharmaceuticals in 2017 with an upfront payment of $575 million, plus $450 million in potential milestones based on label expansions. Tuesday's approval triggered a $225 million payment from Ipsen to Merrimack, the latter company said in its own release.
With those funds expected by late March, Merrimack said it plans to dissolve in May and issue a "liquidating dividend" of $14.65 to $15.35 to its shareholders. Merrimack's board doesn't believe the company is likely to receive any future approval-based milestones for Onivyde, it explained.
Meanwhile at Ipsen, the company and its partner Genfit expect an FDA verdict by June 10 for elafibranor as a second-line treatment for primary biliary cholangitis, a rare autoimmune liver disease.
The launches come as generics gradually erode Ipsen’s top-selling drug, Somatuline. And as ODDO’s analysts noted, Onivyde itself is going to face the patent cliff toward the end of 2027.
That’s why Ipsen is still counting on additional business development deals to drive the company’s next phase of growth. At the end of 2023, Ipsen counted 1.9 billion euros in potential dealmaking firepower.
“Our journey will be driven by the combination of the growth platforms, our new medicines and more external-innovation transactions to come,” Ipsen CEO David Loew said during an investor event in December.