NJ-ORGANON
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240820899473/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Vertex Announces US FDA Approval of ALYFTREK™,a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis20.12.2024 21:46:00 CET | Press release
- ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies - - In head-to-head clinical trials, ALYFTREK was non-inferior on ppFEV1 and further decreased sweat chloride compared to TRIKAFTA® - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK. See below for Important Safety Information, including a Boxed Warning. “ALYFTREK is our fifth CFTR modulator to secure FDA approval and represents another significant milestone in our journey to serially innovate and t
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants20.12.2024 21:35:00 CET | Press release
- Approximately 300 more people with cystic fibrosis in the U.S. are now eligible for a medicine that treats the underlying cause of their disease for the first time - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to TRIKAFTA based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. With this approval, 94 additional non-F508delCFTR mutations have been added to the TRIKAFTA label, and approximately 300 additional people with CF in the U.S. are now eligible for a medicine to treat the underlying cause of their
HSBC Continental Europe Enters Into a Memorandum of Understanding Regarding Potential Sale of HSBC Assurances Vie (France) to Matmut Société d’Assurance Mutuelle20.12.2024 20:32:00 CET | Press release
Regulatory News: HSBC Continental Europe has signed a Memorandum of Understanding (‘MOU‘) regarding the potential sale of its French life insurance business, HSBC Assurances Vie (France), to Matmut Société d’Assurance Mutuelle (‘Matmut’) (the “Potential Transaction”). HSBC Assurances Vie (France) provides a wide range of life insurance solutions and services, with over 20 billion euros of outstanding assets, net income1 of 77 million euros and a Solvency II ratio of 287% in 2023. As part of the Potential Transaction, HSBC Continental Europe and Matmut would enter into a long-term arrangement for HSBC Global Asset Management (France) to continue to partner with HSBC Assurances Vie (France). HSBC Assurances Vie (France) will continue its existing distribution arrangements. The Potential Transaction would provide customers and employees of HSBC Insurance Life (France) with the opportunity to join one of the leading French mutual insurance groups, which is in full development, and forms pa
Andersen Global udvider sin ekspertise med tilføjelsen af Valora20.12.2024 17:07:00 CET | Pressemeddelelse
Andersen Global fortsætter sin udvidelse af servicetilbud gennem en samarbejdsaftale med Valora, der er en uafhængig virksomhed med speciale i levering af skræddersyede løsninger til både private og institutionelle kunder globalt. Valora har kontorer i Miami og Raleigh og desuden global tilstedeværelse i Den Dominikanske Republik, Storbritannien og Caymanøerne. Valora blev grundlagt i 2011 af partneren Luis de Leon og tilbyder et stort udvalg af tjenester, blandt andet værdiansættelse, performance, regnskab og administration, global enhedsstyring, fondsvirksomhed og andre skræddersyede løsninger. "Et samarbejde med Andersen passer godt til både vores kunder og vores team," siger Luis. "Synergierne mellem for vores servicetilbud vil sætte os i stand til at levere omfattende og integrerede løsninger med stadigt stigende global rækkevidde." Global Chairman og CEO for Andersen Mark L. Vorsatz udtaler: "Valoras team og virksomhedskultur er, sammen med deres fokus på det praktiske, et godt m
SBC Medical Group Co., Ltd. Sells Two Subsidiaries20.12.2024 13:00:00 CET | Press release
On December 17, 2024, SBC Medical Group Holdings Incorporated (“SBC Medical”, or the “Company”), announced that its subsidiary, SBC Medical Group Co., Ltd. (hereinafter referred to as "SBCMG"), has decided to sell all shares of its subsidiaries, SBC Kijimadaira Resort Co., Ltd. (hereinafter referred to as "Kijimadaira") and Skynet Academy Co., Ltd. (hereinafter referred to as "SNA"), as outlined below. The decision to sell these subsidiaries was made to concentrate SBCMG's management resources on its core medical services business, in line with its strategy of prioritizing and focusing on key business areas. The subsidiaries being sold operate in the following industries: Kijimadaira: Ski resort operations SNA: Flight training operations The shares will be sold to a company wholly owned by Yoshiyuki Aikawa, the CEO of the Company. Since this transaction constitutes a related party transaction, it was deliberated and approved by the Company’s Board of Directors and Audit Committee. To e
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom