Organon (NYSE: OGN), a global healthcare company focused on women's health, has announced an agreement with Eli Lilly and Company (Lilly) to become the exclusive distributor and promoter of migraine medications Emgality (galcanezumab) and Rayvow (Lasmiditan) in Europe. 1Emgality is a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist indicated for the prevention of migraine patients who have migraine for at least four days per month. Rayvow is a first-in-class serotonin 5-HT1F receptor agonist approved for the acute phase of a migraine attack, with or without aura.
Kevin Ali, CEO of Organon, said: "This commercialisation agreement complements the CNS** products in Organon's Established Brands portfolio and, most importantly, further strengthens our offering to women, who are disproportionately affected by migraines. Our strong commercial expertise and proven track record in this area will help bring these important methods to more in-demand patients in Europe." ”
Migraine is the third most common disease in the worldi, causing repulsive moderate to severe headaches, often accompanied by other debilitating symptoms, including nausea, vomiting, and sensitivity to light and soundii, which can negatively affect an individual's daily life, including family life, career, education, relationships, and incomeiii. The disease is three times more common in women than men and is one of the leading causes of disability in women. iv
Ilya Yuffa, Executive Vice President of Eli Lilly and Company and President of Lilly International, said: "Lilly is committed to helping people with migraine, a debilitating neurological condition. We are confident that our partnership with Organon will help more people across Europe gain access to our innovative approach to migraine**. ”
Under the terms of the agreement, Organon will be the sole distributor and promoter of Emgality and Rayvow in Europe. Lilly will remain the Marketing Authorization Holder for both products and will manufacture both products for sale.
The total consideration to be paid to Lilly consists of an upfront payment of $50 million and sales-based milestone payments. The transaction is expected to close in the first quarter of 2024, subject to review by the relevant authorities in each country.
About emgality
Emgality, a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP), was approved by the European Medicines Agency (EMA) in November 2018.
Indications and usage in the EU:
*Indications: emgality is indicated for the prevention of **migraine patients who have migraine for at least four days per month**. Dosage and method of administration: The use of emgality should be guided by a physician with experience in migraine diagnosis and experience.
Dosage: The recommended dose is 120 mg galcanezumab subcutaneously once a month with an initial loading dose of 240 mg. Patients should be instructed to inject the missed dose as soon as possible and then resume the monthly dose. The effect should be assessed within 3 months of initiation. Any further decision to continue** should be made on a case-by-case basis. It is recommended that there be a regular assessment thereafter of whether there is a need to continue**.
Method of administration: subcutaneous injection.
Patients can self-inject galcanezumab according to the instructions for use. Galcanezumab should be injected subcutaneously in the abdomen, thighs, back of the upper arms, or buttocks. After training, patients can self-inject galcanezumab if they see fit as a health care provider. Complete medication instructions are provided in the package insert.
About Rayvow (Lasmiditan).
Rayvow is an oral** drug that binds to the 5-HT1F receptor with high affinity and has been approved by the EMA for the acute phase of a migraine attack, with or without aura. The efficacy of migraine may be mediated by the agonist effect of the 5-HT1F receptor, but the exact mechanism is unknown. Rayvow is not intended for the prophylactic treatment of migraines**. Patients may be prescribed RATIVO at oral doses of 50 mg, 100 mg, and 200 mg as needed. Do not exceed 200 mg in a 24-hour period.
Indications and usage in the EU:
Rayvow is indicated for the acute phase of a migraine attack, with or without aura.
Dosage and method of administration:
Dosage: In general, the initial recommended dose for acute migraine attacks is 100 mg lasmiditan. If necessary, the dose can be increased to 200 mg to improve efficacy, or reduced to 50 mg to improve tolerability. If the migraine that has received initial relief after taking 50 mg or 100 mg of lasmiditan recurs within 24 hours, a second dose of the same dose can be taken. The second dose should not be taken within 2 hours of the first dose. Do not exceed 200 mg in a 24-hour period.
If the patient does not respond to the first dose, the second dose is unlikely to have an effect on the same seizure. Lasmiditan can be taken with or without food.
Method of administration: oral.
About Organon
Organon is a multinational healthcare company focused on improving women's health throughout their lives. The company offers more than 60 drugs and products in the women's health space, in addition to a growing biosimilar business and a large number of established drug franchises in a range of ** areas. Organon's existing products generate strong cash flow for the company to support investments in innovation and future growth opportunities in women's health and biosimilars. In addition, Organon is also pursuing opportunities to partner with biopharmaceutical innovators looking to commercialize their products by leveraging the company's scale and presence in rapidly growing international markets.
With its massive global scale and geographic reach, Organon has world-class commercial capabilities, employs more than 10,000 people, and is headquartered in Jersey City, New Jersey.