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Celgene exercises option to license AG-221 under global strategic collaboration

Celgene, a partner of US-based Agios Pharmaceuticals, has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein.

As part of the deal, the option to license extended to Celgene through the end of Phase I, but AG-221 has been exercised early based on the Phase I data generated to date.

Currently, AG-221 is in a Phase I dose escalation trial in patients that harbor an IDH2 mutation with advanced hematologic malignancies, including acute myeloid leukemia (AML).

Celgene president of research and early development Thomas Daniel said Agios’ AG-221 candidate is simultaneously advancing convergent fields, including cancer metabolism, epigenetics and precision medicine.

"The emerging Phase 1 clinical data validate the preclinical and mechanistic work on IDH2 mutations in AML, and most importantly, advance a highly promising drug candidate for treatment of molecularly selected patients," Daniel said.

"Celgene looks forward to deploying our worldwide development capabilities in hematological malignancies and to working with Agios to accelerate development."

The companies have entered into a global strategic collaboration in April 2010 for the development of new therapeutics targeting cancer metabolism.

By exercising its exclusive option under the deal, Celgene gets worldwide development and commercialization rights for AG-221.

In addition to contributing its scientific and translational expertise, Agios will also continue to carry out early clinical development and regulatory activities within the AG-221 development program in collaboration with Celgene.

Celgene is responsible for all development costs for AG-221, while Agios is eligible for about $120m in milestone payments and a tiered royalty on any net sales.

Agios also has the right to carry out a portion of any commercialization activities for AG-221 in the US.