Exelixis will continue with development and commercialization.

GlaxoSmithKline (GSK) decided not to exercise its option to license Exelixis’ XL647, a Phase II compound for the treatment of non-small-cell lung cancer (NSCLC), for further development and commercialization. Exelixis reports that it will continue to progress the candidate through clinical trials either independently or in collaboration with third parties.

“We view the data generated with XL647 to date to be compelling and to warrant the aggressive advancement of the XL647 clinical program,” notes George A. Scangos, Ph.D., president and CEO of Exelixis. “We expect XL647 to advance into pivotal registration trials for NSCLC in early 2008 and view this event as a key transformational step for Exelixis as we mature into a commercially focused organization.”

The Exelixis collaboration with GSK covers 10 drug candidates and their back-up and follow-up compounds in Exelixis’ development pipeline. GSK is entitled to select up to three drugs after clinical proof-of-concept. XL647 was the first candidate submitted to GSK. Exelixis expects to submit two additional compounds to GSK later this year and several others, if necessary, in 2008. If XL647 is successfully commercialized, Exelixis will pay GSK 3% royalty on net sales.

XL647 is in two Phase II trials of XL647 in NSCLC. “The data to date for XL647 have shown clear antitumor activity in non-small-cell lung cancer,” points out Thomas Lynch, chief hematology and oncology, director center for thoracic cancers at Massachusetts General Hospital and member of the Speakers’ Bureau for GSK.

“There have been several durable responses in patients with and without EGFR activating mutations, which could give this compound broad utility in a diverse patient population. Small molecule EGFR inhibitors have been a great addition to the treatment of lung cancer, however, there is room for improvement in efficacy and tolerability. XL647 retains activity against the T790M mutation that confers erlotinib resistance, which could potentially provide a necessary step forward in the treatment for lung cancer and potentially other cancers.”

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