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Eisai Co., Ltd.

Drug Names(s): Hydroxymethylacylfulvene, MGI 114, HMAF, Irofulven

Description: Irofulven (hydroxymethylacylfulvene) is the first chemotherapeutic drug candidate in MGI PHARMA’s family of proprietary anti-cancer compounds called the acylfulvenes (alkylating agents). This novel anti-cancer agent exhibits a unique mechanism of action compared to current anti-cancer drugs that allows it to retain activity against a variety of solid tumors, including drug-resistant cancers, and to be synergistic with several classes of approved cancer drugs.

Irofulven's unique mechanism of action involves the rapid uptake of the drug in sensitive tumor cell types, causing DNA single strand breakage, leading to an apoptotic or programmed cell death of tumor cells. Irofulven has demonstrated activity against a broad range of multi-drug resistant tumor cell lines as well as DNA repair deficient cell lines. The drug’s anti-cancer activity has been shown to be independent of p53 and p21 status as well as bcl-2 expression.

Deal Structure: In August 1993, MGI Pharma entered into an exclusive license agreement with the Regents of the University of California. Under the agreement, the university granted to MGI an exclusive, worldwide, royalty-bearing license for the commercial development, manufacture, use and sale of acylfulvene analogs, methods of synthesizing acylfulvene analogs and methods of treating tumors using acylfulvene analogs. MGI paid the university an initial license fee upon execution of the agreement and agreed to pay license maintenance fees on each anniversary of the execution of the agreement until it submits the first NDA relating to the analogs to the FDA. In addition, MGI will make development milestone payments prior to commercialization of the product. MGI has also agreed to pay royalties on net sales revenues, subject to annual minimum requirements.

In December 2007, Eisai and MGI Pharma announced that they entered into a definitive merger agreement under which Eisai would acquire all of the...See full deal structure in Biomedtracker

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