Cambridge, Mass.-based CoLucid is currently in development with lasmiditan tablets, indicated for acute treatment of migraine, and has completed the first of two Phase 3 trials. A data read-out for the second Phase 3 trial is expected in the second half of this year and, if positive, lasmiditan tablets could be submitted for U.S. regulatory approval in 2018, Lilly said Wednesday.
If approved, lasmiditan would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. That could benefit migraine patients who have or are at risk for cardiovascular disease, as well as those dissatisfied with their current therapies, according to Lilly. More than 36 million people suffer from migraine in the United States alone.
“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” stated David Ricks, president and chief executive officer of Eli Lilly. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”
Lilly said the acquisition of CoLucid will bolster its portfolio in pain management for migraine and add a potential near-term launch to its late-stage pipeline. Lilly’s pain management pipeline includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache, and a collaboration with Pfizer Inc. on tanezumab, for the treatment of multiple pain indications, including osteoarthritis, lower back pain and cancer pain.
Lasmiditan was originally discovered at Lilly but was out-licensed to CoLucid in 2005. Lilly said that, at the time, pain management wasn’t a strategic area of focus, but the company has since reorganized its research-and-development efforts to focus on migraine as part of its emerging therapeutic area of pain.
“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” commented Thomas Mathers, CEO of CoLucid. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”
CoLucid also is developing intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults for emergency room and other urgent care settings.
Under the terms of the acquisition agreement, Lilly will buy all shares of CoLucid for $46.50 per share. The transaction is expected to close by the end of the first quarter, pending regulatory approval and other customary closing conditions.