Organon & Lilly Expand Migraine Commercialization Agreement to 11 Additional Markets

(BUSINESS WIRE) -- Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced it has expanded its agreement with Eli Lilly and Company (Lilly) to become the sole distributor and promoter for the migraine medicine Emgality^® (galcanezumab) in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. This expanded partnership builds on Organon’s role as sole distributor and promoter of Emgality in Europe since February 2024.

Emgality, a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, is indicated for the preventive treatment of migraine in adults, and in some markets, the indication specifies prophylaxis for those with at least four migraine days per month. Emgality is also indicated in some markets for the treatment of episodic cluster headache in adults.

“The broadening of this agreement is a testament to Organon’s best-in-class commercialization capabilities, global footprint and deep expertise in women’s health,” said Kevin Ali, Organon CEO. “We know that migraine ranks as the leading cause of disability among young womenⁱⁱ and we’re proud to expand our offering to more women and men around the world living with episodic or chronic migraine.”

Migraine is one of the most prevalent neurological disorders worldwideⁱⁱⁱ causing recurrent moderate-to-severe headaches, often accompanied by other debilitating symptoms, including nausea, vomiting, and sensitivity to light and sound.ⁱ Untreated migraine attacks can last from four to 72 hours.ⁱ Many of these symptoms can still be experienced between migraine attacks, although less frequently and with less intensity, contributing to a reduced quality of life and causing worry for patients in anticipation of the next attack.^iv,v

“We are thrilled to expand this collaboration agreement with Organon,” said Ilya Yuffa, executive vice president of Eli Lilly and Company and president of Lilly International. “We’re confident in our shared mission to bring this important migraine treatment to more patients around the world.”

Under the terms of the agreement, Organon will become the sole distributor and promoter of Emgality in the following additional markets: Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. Lilly will remain the marketing authorization holder and will manufacture the product for sale.

Total consideration to be paid to Lilly for the expansion of territory includes an upfront payment of $22.5 million as well as sales-based milestone payments.

About Emgality^®

Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP).

About Organon

Organon is an independent global healthcare company with a strategy to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Emgality® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Cautionary Note Regarding Forward-Looking Statements

Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s agreement with Lilly and expectations for commercialization of Emgality®. Forward-looking statements may be identified by words such as "foresees" “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties that may affect Organon’s future results include, but are not limited to, an inability of Organon to fully execute on its commercialization plan for Emgality® and/or an inability to obtain required licenses to commercialize that asset; efficacy, safety, or other quality concerns with respect to marketed products, including market actions such as recalls, withdrawals, or declining sales; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance that could adversely affect our cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; an inability to execute on our business development strategy or realize the benefits of our planned acquisitions; political and social pressures, or regulatory developments, that adversely impact demand for, availability of, or patient access to contraception or fertility products; general economic factors, including recessionary pressures, interest rate and currency exchange rate fluctuations; general industry conditions and competition; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; the impact of higher selling and promotional costs; any failure by Organon to obtain an additional period of market exclusivity in the United States for Nexplanon subsequent to the expiration of certain key patents in 2027; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

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ⁱ Allais G, et al. Gender-related differences in migraine. Neurol Sci. 2020;41(Suppl 2):429-436
ⁱⁱ Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain 21, 137 (2020). https://doi.org/10.1186/s10194-020-01208-0
ⁱⁱⁱ Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the Global Burden of Disease Study 2021, Lancet Neurol 2024; 23: 344–81, https://doi.org/10.1016/S1474-4422(24)00038-3
^iv Vincent M, et al. The not so hidden impact of interictal burden in migraine: A narrative review. Front Neurol. 2022;13:1032103
^v Brandes JL. The migraine cycle: patient burden of migraine during and between migraine attacks. Headache. 2008;48(3):430-441. doi:10.1111/j.1526-4610.2007.01004.x

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