Date: 2015-07-09
Type of information: R&D agreement
Compound: histone methyltransferase (HMT) inhibitors
Company: Epizyme (USA - MA) Celgene (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement: R&D collaboration
Action mechanism: histone methyltransferase inhibitor/enzyme inhibitor
Disease:
Details: * On July 9, 2015, Epizyme, a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, announced that it has amended and restated its agreement with Celgene to extend the research collaboration between the two companies for at least three additional years. Under the collaboration, Celgene will have the option to license histone methyltransferase (HMT) inhibitors being developed by Epizyme against three predefined targets. The term of this agreement is based on specific development milestones, including the timing of IND filings and completion of phase 1 studies, but will extend for a minimum of three years. In addition, Celgene will no longer have the right of first negotiation on a business combination with Epizyme .
Financial terms: Under the terms of the revised agreement Epizyme will receive a $10 million extension fee from Celgene in return for an option to individually license global rights for two of the targets and ex-US rights for the third target. Celgene may exercise its option with respect to each of the targets at the time of the IND filing for an additional pre-specified license payment.
Epizyme will be responsible for leading and funding development for each target candidate through phase 1 clinical trials. Following the completion of phase 1, if Celgene chooses to continue its license for a specific target, it may do so by making an additional pre-specified payment.
Epizyme may earn total potential milestones of up to $610 million on the three targets, including up to $75 million in development milestones and license fees, $365 million in regulatory milestones, and $170 million in sales milestones
Epizyme also may earn a royalty of up to a low double-digit percentage on worldwide net sales for two of the product candidates, and on ex-US net sales for the third product candidate.
Epizyme will retain global rights to the remainder of its pipeline, as Celgene\'s option to license ex-US rights for any other preclinical programs will terminate.
In addition, Celgene will retain its ex-US license to, and the companies will continue their ongoing clinical collaboration on, pinometostat (EPZ-5676), a HMT inhibitor targeting DOT1L. Pinometostat is in phase 1 development for the treatment of patients with acute leukemia with alterations in the MLL gene (MLL-r).
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