BMS Bails on Exelixis
Jun21

BMS Bails on Exelixis

Exelixis has lost a second big pharma partner for its most advanced compound in development. Bristol-Myers Squibb is giving back the rights to XL184, a MET inhibitor in several Phase II and III trials in cancer, less than two years after buying into the program for $195 million. GlaxoSmithKline had already given up rights to the drug in October 2008. As part of the termination agreement, BMS will shell out $17 million, a figure that would have covered its financial contribution to the drug's development over the next three months. The South San Francisco-based biotech said in a conference call this morning that despite the loss of about $20 million in expected revenues this year from the collaboration, it will still end the year with a higher cash balance than in 2009. However, that healthier balance sheet has more to do with cost-cutting than milestone payments from partners. In March, the company underwent a major restructuring in order to help support the development of the drug candidate, cutting 40% of staff, or 270 jobs. The move was meant to save the company $90 million through 2011, and help fund the development of XL 184, arguably the most critical compound in the Exelixis pipeline. XL184 blocks three protein kinases, MET, VEGFR2, and RET, and is being studied to treat thyroid cancer, glioblastoma, and a variety of other cancers. If an ongoing Phase III trial in thyroid cancer yields positive results, Exelixis expects to ask FDA for approval in 2011. The  biotech also plans a Phase III in glioblastoma towards the end of this year. “We could not agree with BMS on the prioritization of XL184, the speed, the scope of the program,” George Scangos said this morning. So what's next for Exelixis and XL 184? The biotech firm is clearly on the lookout for partner number three. Scangos told analysts he expected even more suitors at the company’s doorstep, as the data for the compound is more robust than when it was negotiating with BMS in 2008. XL 184 was being watched as one of several drugs in development that block MET, a protein implicated in cancer metastasis. ArQule is developing ARQ197, which recently offered up solid Phase II data in lung cancer. Pfizer’s Crizotinib, which blocks MET and ALK, is also in Phase III trials in lung cancer. GlaxoSmithKline, Exelixis’ previous partner for XL 184, continues to develop XL880, which blocks MET and...

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ArQule Shares Surge on Met-Inhibitor Data
Mar31

ArQule Shares Surge on Met-Inhibitor Data

ArQule’s stock has doubled this morning on new data from a Phase II trial of its lead drug candidate ARQ197, in patients with tough-to-treat lung cancer. ARQ197 targets the Met receptor, a protein involved in helping cancer spread. As we wrote a few years back, in the pantheon of tyrosine-kinase receptors implicated in cancer, Met comes off as a particularly sinister protein. "Met is one of the highest and most frequently occurring gene products in tumors," George Vande Woude, research director of the Van Andel Institute, a cancer research center in Grand Rapids, Mich., and discoverer of the c-Met gene, told us at the time. In ArQule’s trial, a combination of Genentech’s targeted lung cancer drug Tarceva, which blocks the EGFR receptor, and ARQ197 kept the disease from spreading for 16.1 weeks versus a delay of 9.7 weeks in patients given Tarceva alone. The results results were more striking in a subset of the population with a specific cell type. You might look at the data and think, hmm, an extra two months, that’s not much. But its important to remember that these patients are in the latest stages of the disease, and have already been treated with many other drugs that have failed to slow down the cancer. “I think it does provide validation for Met,” says Needham & Co. analyst Mark Monane. “This is solid Phase II data in combination with Tarceva, that’s two targeted therapies together.” ArQule is also studying using the drug in combination with other targeted agents, like Bayer/Onyx’s Nexavar and Eli Lilly’s Gemzar. “Is this the beginning of a beautiful friendship between 197 and commonly used agents? Could be,” Monane says. Those who have been keeping an eye on the c-Met landscape might recall that Exelixis has two of its own c-Met inhibitors in the clinic. However, the South San Francisco-based company is taking a different approach, and rather than potently hitting that one receptor, is blocking several proteins at once. XL184, partnered with Bristol-Myers Squibb and in Phase III trials, hits MET, VEGFR2, and RET, while XL880, partnered with GlaxoSmithKline, inhibits MET and VEGFR2. “I think the jury is out on whether you want a single, targeted c-Met inhibitor or something more promiscuous,” Monane...

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