CAMBRIDGE, MA, Jan. 05, 2016 (GLOBE NEWSWIRE) -- 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, today has announced the publication of a white paper, “Facts Addressing Migraine Market Misperceptions,” intended to serve as a tool to facilitate further discussion around the treatment of migraine, especially for those patients with cardiovascular risk factors or known cardiovascular conditions.
The study outlined in the white paper has been commissioned by CoLucid and has been conducted by IMS Health. The analysis utilizes real-world evidence based on a retrospective study of migraine patients in a proprietary closed-payer dataset, the IMS PharMetrics Plus database. The sample is sufficiently robust so that findings can be projected to the U.S. insured population of 274 million. The Framingham Heart Study, a longitudinal patient study that is the widely-accepted industry standard for defining and assessing cardiovascular risk factors in a U.S. population, was used to determine risk factors for Coronary Artery Disease (CAD).
The analysis shows that the largest group of patients diagnosed and treated for migraine are over the age of 40. The majority of migraine patients, regardless of gender, have either CAD or significant risk factors for CAD. Moreover, the use of prescription drug treatments in general, and triptans specifically, is less in these patients as compared to migraine patients with no cardiovascular risk factors or CAD.
The white paper specifically focuses on commonly held misperceptions regarding 1) the market size and patient demographics for the acute treatment of migraine in the U.S., 2) the proportion of migraine patients who have known cardiovascular conditions or risk factors for cardiovascular disease, and 3) the current treatment patterns of migraine.
A few key facts to address these misperceptions include the following:
- There are 3.7 million adult patients diagnosed with migraine in the U.S. insured healthcare system.
- Most (57%) of the patients diagnosed with migraine and receiving treatment are 40 years and older.
- Women between the ages of 40 and 49 are the largest age cohort for diagnosed and treated patients.
- Migraine patients have a substantially increased rate of experiencing a CAD event compared to the general population (9.9% compared to 6.4%).
- 76%, or 2.8 million, of adult patients diagnosed with migraine have cardiovascular conditions or risk factors that contraindicate or warn against triptan use.
- Triptan use is lower, and off-label use of opioids is disproportionately higher, in patients with cardiovascular issues.
“These data, based on patients who are already in the U.S. healthcare system, illustrate that cardiovascular risk factors and coronary artery disease are common in the migraine population. The fact that physicians alter their use of medications and triptans in such patients indicates to us that a new therapy for the acute treatment of migraine would be a welcome treatment option and could expand the number of migraine patients who receive therapy,” stated Thomas P. Mathers, Chief Executive Officer.
The white paper has been co-authored by Jenn Millard, Principal, IMS Health Real World Evidence Services; Donna DiStefano, Engagement Manager, IMS Health Commercial Services; and Kelly Peters, Vice President, US Commercial Effectiveness Services, IMS Health.
A copy of the white paper can be downloaded from the Company’s website at:
http://www.colucid.com/investor_relations/press_releases
Mr. Mathers, and Matt Dallas, Chief Financial Officer, will be available for investor meetings in San Francisco January 11-13, 2016.
About Lasmiditan
Lasmiditan has been designed to deliver efficacy for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Lasmiditan has been given the generic stem name “ditan,” which distinguishes it from other drug classes, including triptans, the current standard of care for migraine.
CoLucid is also currently enrolling patients in GLADIATOR, a Phase 3 long-term, open-label trial of lasmiditan. GLADIATOR’s objective is to evaluate the safety and efficacy of lasmiditan, as well as resource utilization, functional outcomes and disability. Migraine patients who complete CoLucid’s ongoing first Phase 3 pivotal trial, SAMURAI, as well as the Company’s second Phase 3 pivotal trial, scheduled to commence in the first half of 2016, will be eligible to enroll in GLADIATOR. GLADIATOR is expected to enroll up to a total of 2,580 subjects, who will be randomized to receive 100 mg or 200 mg of lasmiditan, and treated for up to eight migraine attacks per month for one year. Based on the results of GLADIATOR, CoLucid intends to build an appropriate safety database to support a New Drug Application (“NDA”) for lasmiditan. At the time of the NDA submission, it is anticipated that there will be more than 15,000 patient exposures to lasmiditan in the entire clinical program.
About Migraine
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million Americans suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
About CoLucid Pharmaceuticals, Inc.
CoLucid is developing oral lasmiditan for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of unspecified headache pain in adults in emergency room and other urgent care settings.
About IMS Health
IMS Health is a leading global information and technology services company providing clients in the healthcare industry with end-to-end solutions to measure and improve their performance. Our 7,500 services experts connect configurable SaaS applications to 10+ petabytes of complex healthcare date in the IMS One™ cloud platform, delivering unique insights into diseases, treatments, costs and outcomes. The company’s 15,000 employees blend global consistency and local market knowledge across 100 countries to help clients run their operations more efficiently. Customers include pharmaceutical, consumer health and medical device manufacturers and distributors, provers, payers, government agencies, policymakers, researchers and the financial community.
As a global leader in protecting individual patient privacy, IMS Health uses anonymous healthcare data to deliver critical, real-world disease and treatment insights. These insights help biotech and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders to identify unmet treatment needs an understand the effectiveness and value of pharmaceutical products in improving overall health outcomes. Additional information is available at www.imshealth.com.
Forward-Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to CoLucid’s expectations for lasmiditan’s efficacy and potential as a treatment option for migraine. Developments may occur that differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that enrollment goals will not be met, trials may not be commenced or successful or may take longer to complete than anticipated, and projected cash needs and expected financial results may be different, as well as physicians may not prescribe lasmiditan. More information about the risks and uncertainties faced by CoLucid are contained in its periodic reports filed with the Securities and Exchange Commission. CoLucid disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.