Organon and Cirqle Biomedical Enter into Research Collaboration and License Agreement for Investigational Non-Hormonal and On-Demand Contraception Candidate

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JERSEY CITY, NJ–(BUSINESS WIRE)–Organon (NYSE: OGN), a global women’s healthcare company, and Cirqle Biomedical today announced that they have entered into a research collaboration and exclusive licensing agreement for a novel, non-hormonal, investigational contraceptive candidate for Requirement.

“As a leader in contraception, we believe it is extremely important to provide new options for women, especially in the area of ​​non-hormonal contraceptives, a category favored by many with limited options available,” said Sandra Milligan, MD, Head of Organon. of Research and Development. “Organon is committed to driving innovation in women’s health and working with companies like Cirqle Biomedical to support early science and deliver new solutions that address women’s unmet needs.”

Encouraging preclinical research suggests that Cirqle has discovered a method that has the potential to create a temporary barrier to sperm transport by locally reinforcing the existing cervical mucus barrier.

“This collaboration is an important opportunity to advance our preclinical research by exploring the first-class potential of this asset,” said Frederik Petursson Madsen, CEO of Cirqle Biomedical. “We are thrilled to join Organon in leveraging Organon’s deep expertise in women’s and reproductive health to drive potential change for women who use contraception everywhere.”

Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies in accordance with the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset. Cirqle is entitled to receive an upfront payment of $10 million, potential milestone payments of up to $360 million, and royalties based on net sales.

As noted during Organon’s first quarter conference call, to align with views expressed by the United States Securities and Exchange Commission, beginning in 2022, Organon will no longer exclude expenses for upfront and milestones related to collaborations and licensing agreements, or fees related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate of those expenses associated with business development not yet executed, and therefore the initial payment of $10 million has not been included in the guidance for the year 2022 provided. by Organon on May 5, 2022. Organon does not plan to update its inter-quarter guidance based solely on these items.

About Cirqle Biomedical

Cirqle Biomedical is a preclinical-stage life science company focused on developing a first-in-class, non-hormonal contraceptive that can help meet the demand of millions of women for an effective contraceptive with minimal side effects. Cirqle Biomedical’s approach to contraception is based on mucus engineering to take advantage of the natural barrier properties of cervical mucus. Cirqle Biomedical was launched in 2019 in Copenhagen, Denmark, with support from the BioInnovation Institute (BII) and Rhia Ventures, a San Francisco-based impact investor dedicated to women’s reproductive health. The fundamental philosophy of Cirqle Biomedical is to extend the freedom and quality of life for women everywhere. Our goal is to address the greatest unmet medical needs in women’s health by developing breakthrough user-centric innovations.

About Organon

Organon is a global healthcare company created to focus on improving the health of women throughout their lives. Organon has a portfolio of over 60 drugs and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and a stable established drug franchise, Organon’s products are generating strong cash flow that will support investments in innovation and growth opportunities future in women’s health. In addition, Organon seeks opportunities to collaborate with biopharmaceutical innovators seeking to commercialize their products by leveraging its scale and presence in fast-growing international markets.

Organon has a global footprint with significant scale and geographic reach, world-class business capabilities and approximately 9,300 employees headquartered in Jersey City, New Jersey.

For more information, visit http://www.organon.com and join us on LinkedIn and instagram.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s research collaboration and the exclusive licensing agreement with Cirqle Biomedical, the potential for Cirqle Biomedical’s program to produce a first-in-class non-hormonal contraceptive on demand, including the efficacy and market opportunity for Cirqle Biomedical’s investigational asset , and Organon’s goal of addressing the unmet needs of women. Forward-looking statements may be identified by words such as “expects”, “intends”, “anticipates”, “plans”, “believes”, “seeks”, “estimates”, “will” or words with a similar meaning. These statements are based on the current beliefs and expectations of Organon’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 include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic and the emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and around the world; global trends toward health care cost containment; technological advances; new products and patents obtained by competitors; challenges inherent in developing new products, 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 in developing and maintaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and 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. Other 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 Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent filings with the SEC, available on the SEC’s website (www.sec.gov).

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