Organon and Eli Lilly and Company (Lilly) have announced a commercialization agreement that positions Organon as the exclusive distributor and promoter of two migraine medicines, Emgality (galcanezumab) and RAYVOW (lasmiditan), in Europe. Organon, a global healthcare company with a focus on women’s health, will leverage its experience in central nervous system disorders to promote and distribute these medications. Emgality is a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist indicated for the prevention of migraine in adults who experience at least four migraine days per month. RAYVOW, a first-in-class serotonin 5-HT1F receptor agonist, is approved for the acute treatment of migraine attacks in adults, with or without aura.
“This commercialization agreement aligns seamlessly with Organon’s suite of central nervous system treatments in our Established Brands portfolio and, most importantly, it further bolsters our offerings to women, who are disproportionately impacted by migraine,” said Kevin Ali, Organon CEO. “Our strong commercial expertise and proven track record in this therapeutic area will help enable us to bring these important treatments to more patients across Europe who need them.”
Migraine is a common condition globally, often leading to recurrent moderate-to-severe headaches and other symptoms like nausea, vomiting, and sensitivity to light and sound. The condition is notably more prevalent in women than in men and contributes significantly to disability in women.
“Lilly is committed to helping people living with migraine, a debilitating neurological disease,” said Ilya Yuffa, executive vice president of Eli Lilly and Company and president of Lilly International. “We are confident this collaboration with Organon will help even more people throughout Europe gain access to our innovative migraine treatments.”
Under the terms of the agreement, Organon will manage the distribution and promotion of Emgality and RAYVOW in Europe, while Lilly will retain the marketing authorization and continue to manufacture the products. The financial aspects of the deal include an upfront payment of $50 million to Lilly, along with additional sales-based milestone payments. The transaction is anticipated to be completed in the first quarter of 2024, subject to the approval of relevant country-specific authorities.
Emgality, approved by the European Medicines Agency (EMA) in November 2018, is a monoclonal antibody that selectively targets CGRP. RAYVOW, an oral treatment approved by the EMA, binds to 5-HT1F receptors and is intended for the acute treatment of migraine headaches in adults.