Ipsen secures ex-US rights to Day One's pediatric glioma drug Omjeda

Ipsen has entered into a licensing agreement with Day One Biopharmaceuticals to acquire ex-US rights to Ojemda (tovorafenib), an oral, once-weekly, type II RAF inhibitor. This medication is used for treating paediatric low-grade glioma (pLGG) and potentially other future indications. The agreement stipulates that Ipsen will oversee regulatory and commercial activities for Ojemda outside the US.

Under the terms of the deal, Day One Biopharmaceuticals will receive an upfront payment of approximately $111 million, which includes around $71 million in cash and $40 million in equity. Additionally, Day One may receive up to $350 million in milestone payments along with double-digit tiered royalties based on sales of Ojemda.

Ojemda was granted accelerated approval by the FDA in April for the treatment of children aged six months and older who have relapsed or refractory pLGG with BRAF fusion or rearrangement, or BRAF V600 mutation. This approval was based on the results of the Phase II FIREFLY-1 study.

David Loew, the CEO of Ipsen, highlighted the importance of this agreement, noting that there are currently no approved targeted treatments for pLGG caused by BRAF alterations in the refractory or relapsed setting outside the US. He emphasized that this collaboration will enable Ipsen to make tovorafenib available to every eligible patient worldwide.

Day One Biopharmaceuticals maintains exclusive global development rights for Ojemda. The company is conducting further investigations into the drug's efficacy. It is being studied as a first-line monotherapy for BRAF-altered pLGG in the late-stage FIREFLY-2 study. Additionally, Day One is exploring the combination of Ojemda with its MEK inhibitor pimasertib to treat MAPK-altered solid tumors in the FIRELIGHT-1 trial.

This partnership represents a significant step in expanding access to targeted treatments for paediatric low-grade glioma globally. Ipsen's role in handling regulatory and commercial activities outside the US will be crucial in ensuring that children with this rare condition have access to innovative treatment options. Meanwhile, Day One Biopharmaceuticals continues to focus on the development and research of Ojemda, aiming to improve therapeutic outcomes for patients with BRAF-altered conditions.