Business Wire

Organon and Cirqle Biomedical Enter Research Collaboration and License Agreement for Investigational Non-hormonal, On-demand Contraceptive Candidate

Share

Organon (NYSE: OGN), a global women’s healthcare company, and Cirqle Biomedical today announced they have entered into a research collaboration and exclusive license agreement for a novel investigational non-hormonal, on-demand contraceptive candidate.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005145/en/

“As a leader in contraception, we believe it is critically important to bring forward new options for women, especially in the space of non-hormonal contraceptives, a category preferred by many with limited available options,” said Sandra Milligan, M.D., Organon’s head of Research and Development. “Organon is committed to driving innovation across women’s health and collaborating with companies like Cirqle Biomedical to support early science and bring forward new solutions that address the unmet needs of women.”

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

“This collaboration is an important opportunity to advance our preclinical research exploring this asset’s first-in-class potential,” said Frederik Petursson Madsen, Cirqle Biomedical, CEO. “We are excited to join Organon to leverage 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 according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset. Cirqle is entitled to receive a $10 million upfront payment, potential milestone payments of up to $360 million and royalties based on net sales.

As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges 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 for these expenses associated with business development not yet executed, and accordingly, the $10 million upfront payment was not included in the full year 2022 guidance Organon provided on May 5, 2022. Organon does not plan to update its guidance inter-quarter based solely on these items.

About Cirqle Biomedical

Cirqle Biomedical is a pre-clinical stage life science company with the goal of developing a first-in-class non-hormonal contraceptive that can help address the demand from millions of women for an effective contraceptive with minimal side-effects. Cirqle Biomedical’s approach to contraception is based on engineering mucus to leverage the natural barrier properties of cervical mucus. Cirqle Biomedical was launched in 2019 in Copenhagen, Denmark, with backing from BioInnovation Institute (BII) and Rhia Ventures, a San Francisco-based impact investor dedicated to women’s reproductive health. Cirqle Biomedical’s core ethos is to expand freedom and quality of life for women everywhere. We aim to solve the most prominent unmet medical needs in women’s health by developing groundbreaking user-centric innovations.

About Organon

Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking 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 commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn and Instagram.

Forward-Looking Statements

This press release includes “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 research collaboration and exclusive license agreement with Cirqle Biomedical, the potential for Cirqle Biomedical’s program to produce a best-in-class non-hormonal, on-demand contraceptive, including the effectiveness of 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 of similar meaning. These statements are based upon 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 emergence of variant strains; 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; 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 Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov).

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Organon Media Contacts:

Karissa Peer
(614) 314-8094

Kate Vossen
(732) 675-8448

Organon Investor Contacts:

Jennifer Halchak
(201) 275-2711

Edward Barger
(267) 614-4669

Cirqle Media Contacts:

Onor Wilkinson
ow@cirqle.bio

Cirqle Investor Contacts:

Frederik Petursson Madsen
fm@cirqle.bio

About Business Wire

Business Wire
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

Nonprofit Funding Platform Heroe5 Launches The Good Society, Embracing Web3 Approach to the Sustainable Financial Benefit for Charities9.8.2022 19:00:00 CEST | Press release

Nonprofit funding platform Heroe5™ announced today the creation ofThe Good Society™to address the growing need for sustainable funding platforms for charitable organizations. The Good Society becomes the first project focused on Web3 solutions to raise awareness and support global causes working to positively impact our communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005376/en/ “The Good Society is a vital next step in the evolution of the fundraising industry: a Web3 platform to create art impact experiences,” said Sebastien Heimann, founding member and CEO of Heroe5 and The Good Society. “As the world moves to Web3, charities need more fundraising tools to stay ahead of the curve and embrace new ways to engage potential donors. The Good Society will provide those innovations, allowing them to raise critical funding and awareness for vital causes while feeding the public’s growing interest in digital colle

The Nature Conservancy and Global Partners Hold Session on Improving Protected Marine Areas at UN Oceans Conference With Support From Mary Kay Inc.9.8.2022 18:33:00 CEST | Press release

The United Nations Ocean Conference 2022 took place from June 27 to July 1, in Lisbon, Portugal, and brought together more than 5,000 participants, including world leaders, entrepreneurs, youth, influencers, and scientists. The conference aimed to facilitate these stakeholders in finding science-driven innovations and solutions to respond to a multidimensional ocean crisis driven by climate change, overfishing, habitat loss, and pollution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220809005180/en/ The Nature Conservancy logo (Logo: The Nature Conservancy) The Nature Conservancy (TNC), with support from Mary Kay Inc., held an event in collaboration with United Nations Environment Programme (UNEP), the Government of Ecuador, the Jocotoco Foundation, the Charles Darwin Foundation for the Galapagos Islands, Re:wild, and the Marine Conservation Institute. TNC and UNEP moderated the event, highlighting the critical importance

Forescout Joins CISA’s Joint Cyber Defense Collaborative9.8.2022 18:00:00 CEST | Press release

Forescout Technologies Inc., the global leader in automated cybersecurity, today announced it has joined the Joint Cyber Defense Collaborative (JCDC) to further support the U.S. government’s focus on the cybersecurity and resilience of its industrial control systems and operational technology (ICS/OT). Established by the Cybersecurity and Infrastructure Security Agency (CISA), JCDC connects cyber defenders to enable critical thinking and planning against cyberattacks. “It’s an honor to be included in the newly expanded JCDC-ICS to share Forescout’s leadership and deep expertise in ICS/OT security,” said Tim Jones, Forescout’s US Federal Government VP of Systems Engineering. “Having worked directly with CISA for years, I know this type of collaboration between industry leaders in cybersecurity is exactly what our nation needs to protect against cyberattacks that threaten critical infrastructure systems on which our daily lives depend.” Forescout’s cybersecurity solutions are used by man

Simplifying Software Security: Veracode Enhances Frictionless Experience for Developers9.8.2022 16:50:00 CEST | Press release

Black Hat (booth #2428) – Veracode, a leading global provider of application security testing solutions, today announced the enhancement of its Continuous Software Security Platform with substantial improvements to its integrated developer experience. New features include extended integrations to support software composition analysis (SCA), a software bill of materials (SBOM) Application Programming Interface (API), and additional language and framework support for static analysis, further enhancing developers’ ability to secure software in the environments where they work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220809005141/en/ Fig. 1 Veracode “Beat the Heat” security flaw heat map, State of Software Security Report v12 (Graphic: Business Wire) Brian Roche, Chief Product Officer at Veracode, said, “Modern applications are mostly assembled, not written from scratch. Open-source code makes up a significant proportion

TNS Targets Global Growth with Strategic Acquisition of AGNITY Global9.8.2022 16:01:00 CEST | Press release

Transaction Network Services (TNS) has today announced the acquisition of AGNITY Global, a leading provider of intelligent business communication applications and infrastructure to organizations in the telecommunications and healthcare industry verticals. The move strategically enhances TNS’ Communications Market global capabilities through AGNITY’s established channel partnerships business model that spans more than 12 countries. It will also enable TNS’ existing customers to benefit from a broader portfolio of next generation solutions. Headquartered in Silicon Valley with development and support operations in Richardson, Texas and Noida, India, AGNITY powers the networks of many global Tier-1 service providers via its scalable, carrier-grade Communication Application Server (CAS). This network agnostic, multi-service software platform offers app components and open APIs that enable service providers to address network technology transition challenges as well as future-proofing their

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