Eli Lilly says it will spend nearly $1 billion to buy out CoLucid Pharmaceuticals and get its hands on its late-stage acute migraine candidate, which Lilly outlicensed to the company back in 2005.
The all-cash transaction works out to $46.50 a share, after trading at $34.90 at end of play yesterday.
Lilly said in a statement that this will “enhance its existing portfolio in pain management for migraine,” while also adding a potential near-term launch to its late-stage pipeline.
This drug, lasmiditan, is an oral 5-HT1F agonist and has already finished the first of two pivotal phase 3 trials.
A data readout for the second test, known as SPARTAN, is expected in the second half of 2017. “If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018,” the pair say.
Lasmiditan was originally discovered at Lilly and was outlicensed to CoLucid 12 years ago. “At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly,” the company said, but added that it has “since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.”
The Big Pharma figures that as many as 36 million people suffer from migraine in the U.S. and sees lasmiditan, if approved, as being a first-in-class therapy to treat migraine through a new mechanism of action, and without vasoconstriction.
“This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies,” it notes.
This bulks out Lilly’s pain pipeline, which includes galcanezumab, currently in phase 3 to help stop migraines and cluster headaches.
And there’s tanezumab, which is being studied in partnership with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer 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,” said Thomas Mathers, CoLucid's CEO. “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 went public with a $55 million IPO in 2015 at $10 per share, with major venture investors including Care Capital, Novo A/S, Domain Partners, TVM Life Science Ventures and Trialthlon Medical Ventures, as well as Pappas Ventures, which founded the company back in 2005.
In the more than 2,200-patient phase 3 SAMURAI study, posted last year, the drug met the primary endpoint of efficacy for low-dose and high-dose lasmiditan versus placebo based on migraine headache pain two hours after dosing. It also met the secondary endpoint of freedom from the most bothersome migraine symptom two hours after dosing.
The second 2,200-plus patient pivotal trial, SPARTAN, is evaluating three doses, with an additional lower-dose arm but with the same primary and secondary endpoints as the SAMURAI trial. It’s expected to examine a patient subgroup of those with cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease.