Affamed to obtain sole commercialization rights upon regulatory approval in Mainland China to Galcanezumab, a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). Target to address unmet medical needs for millions of Chinese migraine patients.
SHANGHAI, Jan. 17, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to address critical unmet medical needs in neurological, psychiatric and ophthalmic disorders today announced that it has entered into an agreement with Eli Lilly and Company ("Eli Lilly") to obtain sole commercialization rights to import, market, promote, distribute and detail Galcanezumab once approved in Mainland China. A new drug application for Galcanezumab as a preventative treatment for episodic migraine in adults was submitted by Eli Lilly to China's National Medical Products Administration ("NMPA") in June 2022.
Migraine is a disabling, neurologic disease affecting almost one in every ten Chinese with an estimated 130 million prevalent cases, of which approximately two-thirds are women[1]. Despite its high prevalence, migraine remains under-recognized and under-treated in China. Building on its deep and long-standing scientific and commercial experience and insight in the Chinese migraine market, AffaMed views this collaboration with Eli Lilly as a critical opportunity to address the significant unmet need and to improve the quality of life for migraine patients in China.
"We are excited to reach this agreement with Eli Lilly to bring this innovative product to Chinese patients who are suffering from migraine with symptoms that dramatically impair their quality of life." Dr. Dayao Zhao, CEO of AffaMed commented: "This agreement further demonstrates AffaMed's aspiration to provide innovative treatments to Chinese patients and represents an important milestone in strengthening AffaMed's neurology pipeline."
In the Phase 3 PERSIST[2]Study, a randomized, double-blind, placebo-controlled pivotal trial designed to assess the efficacy and safety of Galcanezumab in patients with episodic migraine from China, India, and Russia, the least squares (LS) mean reduction from baseline in monthly MHDs over 3 months was significantly greater with Galcanezumab compared with placebo (-3.81 days vs. -1.99 days; p < 0.0001). Significantly greater mean proportions of patients with galcanezumab versus placebo had ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs (all p < 0.0001).
About Migraine
Migraine is a severely disabling neurologic disease characterized by recurrent episodes of moderate to severe headache accompanied by other symptoms including nausea, sensitivity to light, and sensitivity to sound.[3],[4] The prevalence rate among the Chinese population is 9.3%, but with the prevalence rate observed in women at 12.8% more than double the prevalence rate observed in men at 5.8%.[1] It has been reported to be the second most disabling disease that affects daily activities among all diseases.[5]
About Galcanezumab
Galcanezumab is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP). It is developed by Eli Lilly and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults, and in June 2019 for the treatment of episodic cluster headache in adults. Galcanezumab (launched under the brand name Emgality® in the United States) is an innovative therapeutic approach for this neurologic disease and also the first and only medication approved by the US FDA to reduce the number of attacks for the treatment of episodic cluster headache. It is currently used for patients with migraine in 20 countries around the world.
About AffaMed Therapeutics
AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.
Disclaimer
The product mentioned is currently an investigational drug in the mentioned indication, not yet approved in Mainland China. Affamed and Lilly do not recommend any unapproved drugs/indications for use.
References
[1]. Yu S, Liu R, Zhao G, et al. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. 2012, 52:582 ~ 591. |
[2]. Hu et al. Galcanezumab in episodic migraine the phase 3, randomized, double–blind placebo–controlled PERSIST study, The Journal of Headache and Pain. 2022 |
[3]. Katsarava Z, Buse D, Manack A, et al. Defining the differences between episodic migraine and chronic migraine. Current Pain Headache Reports. 2012;16:86. |
[4]. Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL, and resource use amongst chronic and episodic migraineurs. Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301. |
[5]. GBD 2016 Headache Collaborators (2018) Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 17(11):954–76 |