CoLucid Pharmaceuticals, Inc., a biotech company focusing on therapies for CNS disorders, and Ildong Pharmaceutical Co., Ltd., a leading Korean company focused on the development, manufacturing and marketing of pharmaceuticals and OTC products, have entered into a distribution and supply agreement for Lasmiditan in South Korea and Southeast Asia.
Under the terms of the agreement, CoLucid will receive upfront and milestone payments in addition to consideration for product supply in exchange for exclusive rights to Ildong for development and commercialization of Lasmiditan in the territory. Ildong will be responsible for the costs and activities related to development and regulatory approvals in the territory and will also participate in key registration trials as part of the global development plan.
"We are very happy to announce the collaboration with Ildong. We look forward to working together with such a strong partner to bring Lasmiditan to the market to meet the many unmet needs of migraine sufferers," said Thomas P Mathers, CEO of CoLucid.
Ildong Pharma chairman and CEO, Jung-chi Lee, commented, "We expect CoLucid's innovative drug, Lasmiditan, to be successfully developed under our partnership and be subsequently well positioned to perform in the Korean market and Southeast Asia in the near future. We are sure that this will provide us a further opportunity to strengthen the relationship between our two companies."
Lasmiditan has been designed to deliver efficacy in acute migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. It selectively targets 5-HT1F receptors expressed in the trigeminal pathway. Its novel chemical class and differentiated site and mechanism of action led to Lasmiditan's designation as a "ditan", a new drug class, by the INN.
CoLucid has successfully completed six clinical studies for Lasmiditan, including a phase 2b study treating a single migraine attack in 391 patients, as well as a TQTc study.
Phase 3 development will address two major unmet needs in patients who are poorly served by currently available therapies: Patients with risk factors for cardiovascular disease and those with cardiovascular disease; Patients who have not had adequate response to triptans.
Migraine is ranked as the seventh highest cause of global disability and in the top 10 causes of disability in 14 of 21 world regions studied, according to findings by the Global Burden of Disease Survey 2010 conducted by the World Health Organization. It is the leading cause of disability among neurological disorders. Some 36 million Americans have migraine, more than have asthma or diabetes combined. Migraine can be extremely disabling and costly, accounting for more than $20 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States. The prevalence of migraine in Asia is approximately 9%, and in South Korea alone, it is 6%. According to statistics available from the Health and Insurance Review Agency (HIRA), in 2012 more than 500,000 patients were diagnosed with migraine in Korea, with women accounting for 72% of these numbers.
CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders.