Celgene Corporation and Agios Pharmaceuticals, Inc,  a company specializing in treatments relating to cancer and rare genetic disorders of metabolism,plan to advance into clinical development Agios’ AG-881, a small molecule that has shown in preclinical studies to fully penetrate the blood brain barrier and inhibit isocitrate dehydrogenase-1 (IDH1) and IDH2 mutant cancer models. The companies into a new joint worldwide development and profit share collaboration for AG-881 and plan to initiate clinical development of AG-881 in the second quarter of 2015. AG-881 will be the third IDH mutant inhibitor discovered by Agios to enter clinical development.

Under the terms of the new AG-881 collaboration, Agios will receive an initial payment of $10 million in the second quarter of 2015 and is eligible to receive regulatory milestone payments of up to $70 million. Agios and Celgene will jointly collaborate on the worldwide development program for AG-881, sharing development costs 50/50 worldwide. The two companies have agreed to share any worldwide profits 50/50, with Celgene booking worldwide commercial sales. Agios would lead commercialization in the US with both companies sharing equally in field-based commercial activities, and Celgene would lead commercialization ex-US with Agios providing one third of field-based commercial activities in the major European Union markets.

Agios and Celgene entered a global, strategic collaboration in April 2010 and, to date, three potential new investigational medicines have emerged: the IDH2 mutant inhibitor, AG-221; the IDH1 mutant inhibitor, AG-120; and the pan-IDH mutant inhibitor, AG-881, which as described previously is now part of a new collaboration between the companies. These three investigational medicines aim to improve the treatment outcomes for patients whose cancers carry these IDH mutations, including difficult to treat acute myelogenous leukemia and glioma, a type of aggressive brain tumor with poor prognosis.

Each of these investigational medicines carries different financial terms and rights under the collaboration. Celgene has worldwide development and commercialization rights for AG-221. Agios is eligible for up to $120 million in milestone payments and royalties on any net sales. Agios retains US development and commercialization rights while Celgene has development and commercialization rights outside the US. Agios is eligible to receive royalties on any net sales outside the US and up to $120 million in milestone payments. Celgene is eligible to receive royalties on any net sales in the US. The companies have joint worldwide development and 50/50 profit share collaboration for AG-881. Agios is eligible to receive regulatory milestone payments up to $70 million.

Source: Agios Pharmaceuticals