NEW YORK – Ipsen on Thursday said it has licensed regulatory and commercial rights outside of the US to Day One Biopharmaceuticals' RAF inhibitor Ojemda (tovorafenib) for the treatment of BRAF-altered pediatric low-grade glioma and other indications.
Under the deal, Paris-based Ipsen will be responsible for regulatory and commercial activities for Ojemda in all indications in all territories outside of the US, and Day One will retain exclusive global development and US commercial rights for Ojemda. Day One will receive an upfront payment of $111 million, including $71 million in cash and a $40 million equity investment. Day One will also be eligible for up to $350 million in additional milestone payments and will receive tiered royalties starting at mid-teens percentage on sales.
"Our collaboration with Ipsen to bring tovorafenib to patients worldwide highlights our shared commitment to bring novel therapeutics to patients who have limited treatment options," Day One CEO Jeremy Bender said in a statement. "We believe Ipsen's footprint in Europe and major regions outside of the US, in addition to their track record of bringing innovative medicines to market in oncology and rare pediatric diseases, will be an enormous benefit to tovorafenib and to the pediatric oncology community worldwide."
In April, the US Food and Drug Administration granted accelerated approval to Ojemda as a treatment for pediatric patients with relapsed or refractory low-grade glioma who have a BRAF fusion or rearrangement or a BRAF V600 mutation. The approval was based on data from the Phase II FIREFLY-1 trial, in which 51 percent of patients responded to Ojemda and the median duration of response was 13.8 months.
Day One, headquartered in Brisbane, California, is also evaluating Ojemda as a frontline treatment for newly diagnosed RAF-altered pediatric low-grade glioma in the Phase II FIREFLY-2 study. The firm is further studying the drug in patients with recurrent or progressive solid tumors with MAPK pathway aberrations. In 2022, Day One partnered with the US National Cancer Institute to explore Ojemda as a treatment for solid tumor and hematologic cancers with MAPK alterations.