Firm hopes to file NDA in 2011 for XL184 as a treatment for medullary thyroid cancer.

Exelixis is regaining full rights to its pivotal-stage anticancer drug XL184 and will be paid $17 million by Bristol-Myers Squibb as a consequence of the latter’s decision to return its co-development rights to the drug.

Exelixis suggests BMS has given up with the agreement for XL184 due to its inability to keep up with the pace of development Exelixis is expecting. The original deal signed between Exelixis and BMS in 2008 covered co-development and commercialization of XL184 in global markets.

“We certainly understand BMS’ need to make pipeline and prioritization decisions,” points out George A Scangos, Ph.D., Exelixis’ president and CEO. “But from Exelixis’ perspective, XL184 is our most advanced compound, the data is encouraging, and we need to rapidly develop the compound in indications justified by the data, including medullary thyroid cancer, glioblastoma, and potentially some of the major tumor types being evaluated in the randomized discontinuation trial. We have the resources to take XL184 forward on our own for some time, and we see several attractive longer term options, which we are currently evaluating.”

XL184 is an investigational oral inhibitor of MET, VEGFR2, and RET. The drug is currently being evaluated across 13 tumor types across multiple clinical trials. The latest promising trial data were presented at the recent Annual Meeting of the American Society of Clinical Oncology. Exelixis says it hopes to file an NDA submission for XL184 in the treatment of medullary thyroid cancer in 2011, pending positive results from an ongoing Phase III trial in this indication.

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