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Johnson & Johnson

Drug Names(s): trabectedin, ET-743, ecteinascidin 743

Description: Yondelis (trabectedin) is a tetrahydroisoquinoline, a novel marine-derived anti-tumour agent isolated from the colonial tunicate Ecteinascidia turbinata.

Yondelis has a unique, multi-component mechanism of action. It is the only chemotherapy agent that binds to the minor groove of the DNA, bending the DNA towards the major groove, exerting its therapeutic effect through several pathways: It interferes with cellular transcription-coupled nucleotide excision repair (TC-NER) mechanism to induce cell death; it causes slowing and arrest of tumour cell division and subsequent p53-independent apoptosis (programmed cell death); and it inhibits transcriptional activation of inducible genes.

Deal Structure: Yondelis is PharmaMar's lead compound in clinical development and is being co-developed by PharmaMar and Tibotec Therapeutics, Division of Ortho Biotech Product, LP, (Johnson & Johnson). PharmaMar will market Yondelis in Europe, whilst Tibotec Therapeutics, will market it in the US and rest of the world.

In 2007, Swedish Orphan in-licensed rights to Yondelis from PharmaMar. The agreement covers distribution and marketing of Yondelis within Sweden, Denmark, Norway, Finland, Iceland, Lithuania, Latvia, Estonia, Poland, Romania, Czech Republic, Bulgaria, Hungary, Slovakia, Slovenia.

In July 2008, PharmaMar announced that from now on the development and, where appropriate, the marketing of Yondelis in Japan will be carried out by PharmaMar and to this end PharmaMar may collaborate with other licensees. As well as the return of the rights for Yondelis in this country PharmaMar receives US$ 10 million from OBI and will maintain a milestone payment when the marketing authorization...See full deal structure in Biomedtracker

Partners: PharmaMar Otsuka Holdings Co., Ltd. Swedish Orphan Biovitrum

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