Just three months after scoring an accelerated FDA approval for Ojemda, Day One Biopharmaceuticals is teaming up with another fellow oncology specialist to grow the medicine's global reach.
Thursday, Day One and Ipsen unveiled an ex-U.S. licensing agreement for tovorafenib (approved as Ojemda in the U.S.) in pediatric low-grade glioma (pLGG) and "any future indications developed by Day One."
In exchange for regulatory and commercial rights to tovorafenib outside the U.S., Ipsen is forking over $111 million upfront, including a $40 million equity investment in Day One. Based on potential success down the road, Day One could be in line for up to $350 million in milestones plus "tiered double-digit royalties."
In a release, Ipsen said its "deep heritage and expertise in oncology" will allow the company to "accelerate the delivery of this innovation as teams focus on regulatory activities outside the U.S."
As the company noted, patients with pLGG suffer from symptoms including vision and speech problems, neurological symptoms, fatigue, nausea and more. The disease can "significantly" impact a child's development and quality of life.
The deal comes three months after Ojemda secured accelerated FDA approval as a treatment for pLGG in patients 6 months and older whose tumors have a BRAF fusion or rearrangement, or a BRAF V600 mutation. In their Thursday release, Ipsen and Day One described pLGG as the "most common childhood brain tumor."
In the disease, Day One's drug is going up against Novartis' combination of Tafinlar and Mekinist, which in 2023 scored its own FDA nod to treat pLGG cases with BRAF V600 mutations, a more restricted use.
Ojemda is California-based Day One's first commercial product and carries a peak sales estimate of $750 million from analysts at JPMorgan.
As for Ipsen, the company separately on Thursday presented its first-half financial results. The drugmaker's first-half sales grew 8% year over year, reaching 1,659 billion euros ($1.8 billion).
During the first half, Ipsen said its Exelixis-partnered cancer med Cabometyx and Dysport for spasticity and cervical dystonia drove its sales growth, along with Bylvay for patients with Alagille syndrome and Onvyide for certain cancers.
While the company's profit margin declined slightly during the first six months of the year, Ipsen attributed the decrease to higher R&D spending.
With the first half in the books, Ipsen said it expects a full-year sales increase of 7% compared with its prior guidance of 6%.