Bristol-Myers dumps rights to Lilly's troubled PhIII Erbitux successor

Three years after Bristol-Myers Squibb and Eli Lilly settled a nasty legal scrap over the rights to necitumumab--a cancer drug initially pursued by ImClone and pushed ahead into late-stage tests--BMS ($BMY) has dumped its rights to the troubled program. Lilly ($LLY) disclosed the move in its fourth-quarter release, noting that it now controls worldwide rights to the drug, one of 13 late-stage assets touted as Eli Lilly's main case for a near-term turnaround after a long, expensive and often unfruitful R&D effort.

Biotech aficionados might recall that necitumumab was initially dubbed IMC-11F8, a fully human antibody and next-gen version of Erbitux, an animal/human hybrid which also targets EGFR. Researchers felt that its fully human attributes would make it safer and more effective in combating tumors with fewer doses required. BMS, which started the bidding war for ImClone that Eli Lilly eventually won for $6.5 billion, secured part of the rights for the drug after the buyout.

About two years ago, though, investigators stopped enrollment in one of two Phase III studies for advanced non-small cell lung cancer after patients in the drug arm developed blood clots. A second trial--a combo study adding Gemzar and cisplatin--continued.

"The company received notification from its partner, Bristol-Myers Squibb, to terminate the collaboration for necitumumab in North America and Japan, which will result in Lilly assuming sole worldwide development and commercialization rights," Lilly stated. "Necitumumab is currently in Phase III testing as a potential treatment for squamous non-small cell lung cancer."

The end of the partnership marks another setback for Lilly, which has maintained that its 13 Phase III programs will deliver the new products needed to counter the looming threat of new generic competition. Aside from its work on new diabetes drugs, though, Lilly has found it hard to make progress. And along with the necitumumab breakup, Boehringer Ingelheim also recently dropped its partnership on one of four late-stage diabetes drugs partnered with Lilly. Lilly also regained rights to LY2605541, a Phase III basal insulin analog, last quarter.

- here's the release from Lilly

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