In another move to boost its oncology portfolio, Ipsen is handing Day One Biopharmaceuticals $111 million upfront so it can take the pediatric brain tumor treatment tovorafenib to market outside the US.
Paris-based Ipsen will take the reins on ex-US regulatory and commercial moves for the drug in pediatric low-grade glioma (pLGG). The upfront payment includes about $71 million in cash and $40 million as an equity investment. There are also $350 million in launch and milestone payments on the line for Day One, as well as tiered royalties.
Tovorafenib received an accelerated approval from the FDA in April with the brand name Ojemda for patients as young as 6 months old who have relapsed or refractory pLGG with a BRAF fusion or rearrangement or have a BRAF V600 mutation. The oral type II RAF inhibitor is a once-weekly drug.
Ipsen will apply to the EMA with a filing planned for next year. From there, regulatory efforts would “expand very rapidly” to other countries, Ipsen CEO David Loew told Endpoints News. “We’re going to work together with [Day One] to try to accelerate the submission for Europe. There are some CMC activities that still need to be done, which are just standard parts of European filing,” he said.
Day One will still run clinical trials by itself, but as part of the deal announced Thursday, Ipsen can also take regulatory and commercial responsibilities for the asset outside the US in other indications. Tovorafenib is in a Phase 3 trial in first-line pLGG with RAF alterations.
The deal with Day One follows a spate of oncology deals Ipsen has announced in recent weeks. Also this month, Ipsen signed a deal with Foreseen Biotechnology to take on the global license for an antibody-drug conjugate. In June, it expanded its collaboration with Exelixis on the cancer drug Cabometyx and extended its research deal with Marengo Therapeutics.
These four deals harken back to a 2020 announcement, when Ipsen said it would expand in oncology, rare disease and neuroscience, Loew said, adding that the company has brought in over 25 new medicine candidates into the fold in the past two and a half years.
Ipsen sees more deals in the future since it does not have a basic research arm, Loew said. “We have observed that [fundamental research] hasn’t been really delivering for a lot for pharma companies. Most of the science these days — I would say 99.9% of the science — comes actually from universities or startup biotechs,” he added.