The agreement builds on Organon’s global
product portfolio for conditions that impact women
disproportionately. Women are three times more likely to experience
migraine than men.i
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).
_________________________ 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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