Former CoLucid Drug, Lasmiditan, Receives FDA Approval

Former CoLucid Drug, Lasmiditan, Receives FDA Approval

INDIANAPOLISOct. 11, 2019 — Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists).

Lilly Completes Acquisition of CoLucid Pharmaceuticals

INDIANAPOLIS, IN, March 1, 2017 – Eli Lilly and Company (NYSE:LLY) today announced the successful completion of its acquisition of CoLucid Pharmaceuticals, Inc. (NASD:CLCD). The tender offer for all outstanding shares of common stock of CoLucid, at a price of $46.50 per share, expired as scheduled on Tuesday, February 28, 2017.

Lilly and CoLucid Pharmaceuticals Announce Agreement for Lilly To Acquire CoLucid

INDIANAPOLIS, IN and CAMBRIDGE, MA, January 18, 2017 – Eli Lilly and Company (NYSE: LLY) and CoLucid Pharmaceuticals, Inc. (Nasdaq: CLCD) today announced an agreement for Lilly to acquire CoLucid for $46.50 per share or approximately $960 million. This all-cash transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

CoLucid Pharmaceuticals Announces Achievement of Both Primary and Key Secondary Endpoints in the SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine

CAMBRIDGE, Mass., September 6, 2016 – Cambridge, MA, September 6, 2016 — CoLucid Pharmaceuticals, Inc., a biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura, announced today that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).

CoLucid Pharmaceuticals Announces Last Patient Randomized in SAMURAI Phase 3 Pivotal Trial of Lasmiditan in Migraine

CAMBRIDGE, Mass., June 7, 2016 – CoLucid Pharmaceuticals, Inc. (Nasdaq:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing lasmiditan oral tablets for the acute treatment of migraine in adults, announced today that the last patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan. Per the SAMURAI protocol, the last patient randomized will have up to eight weeks to complete the study. SAMURAI top-line data are expected to be released when available in the third quarter of 2016, with more detailed results to be presented at a symposium during the 5th European Headache and Migraine Trust International Congress (EHMTIC 2016) taking place in Glasgow, Scotland on September 17th, 2016.

CoLucid Pharmaceuticals Announces Special Protocol Agreement for SPARTAN

CAMBRIDGE, Mass., Mar. 1, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine, has announced that it has received a Special Protocol Agreement for its second pivotal Phase 3 clinical trial, called SPARTAN, from the U.S. Food and Drug Administration (“FDA”). The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the key secondary endpoint. SPARTAN is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 130 sites in the U.S., United Kingdom and Germany. CoLucid expects migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease (“CAD”).

CoLucid Pharmaceuticals Announces Confirmatory Support for Non-vasoconstrictive Mechanism of Action for Lasmiditan

CAMBRIDGE, Mass., Feb. 23, 2016 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches, announced today the completion of a preclinical in vivo study examining the effect of lasmiditan on coronary and carotid artery diameters. This study confirms the lack of effect of lasmiditan on coronary artery and carotid artery vasoconstriction; the data are expected to be used in support of potential future regulatory filings.

CoLucid Pharmaceuticals Provides SAMURAI Enrollment Update

CAMBRIDGE, MA, November 30, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ: CLCD) today announced that over 50% of the migraine patients needed to complete the Company’s SAMURAI trial, the first of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SAMURAI is to evaluate the efficacy of lasmiditan (100 mg and 200 mg) oral tablets in comparison to placebo two hours following dosing. The primary endpoint is freedom from migraine headache pain and the key secondary endpoint is freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia).

SAMURAI is a randomized, double-blind, placebo-controlled parallel group study that is expected to randomize 2,225 migraine patients and treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. SAMURAI is being conducted under a Special Protocol agreement with the U.S. Food and Drug Administration.

CoLucid Pharmaceuticals Announces Election of Mark Corrigan, M.D., to Board of Directors

CAMBRIDGE, Mass., Oct. 27, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that Mark Corrigan M.D., has been elected by the Board of Directors to serve as a director. Dr. Corrigan is filling a seat created by the resignation of Richard Markham, and will serve as a class II director of the Company with a term expiring at the annual meeting of stockholders to be held in 2017. In addition, Dr. Corrigan has been elected as Chairman of the Compensation Committee. CoLucid’s Board remains at seven directors, six of whom are independent.