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

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Feeling ’22: Mary Kay Inc. Announces Awards, Milestones, and Accomplishments From First Half of the Year28.7.2022 20:02:00 EEST | Press release

Mary Kay Inc. is feeling ’22. Throughout the first half of the year, the iconic global entrepreneurship company has furthered its innovations in skin science, continued its social impact efforts, and garnered several prestigious awards for its business and leadership. It’s a thing of beauty—and the nearly 60-year-old brand is just getting started. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005228/en/ Mary Kay logo (Graphic: Mary Kay Inc.) 2022 AWARDS & HIGHLIGHTS 30 total awards for business excellence, social impact and sustainability 10 employer awards recognizing Mary Kay as a great place to work and for operational excellence 7 awards for Mary Kay’s c-suite and senior leadership 17 self-released reports reinforcing Mary Kay’s operational and philanthropic efforts supporting its sustainability commitments for its Enriching Lives Today for a Sustainable Tomorrow strategy 3 mentions in annual reports from social i

Asaf Ashkenazi Named CEO of Verimatrix28.7.2022 19:00:00 EEST | Press release

Regulatory News: Verimatrix (Euronext Paris: VMX) (Paris:VMX), today announced the appointment of Asaf Ashkenazi as Chief Executive Officer effective Monday, August 1st, 2022. Amedeo D’Angelo, Chairman and Chief Executive Officer since 2015, remains Executive Chairman of Verimatrix effective the same day. Asaf Ashkenazi joined Verimatrix in 2018 and currently serves as Chief Operating Officer. He will lead the company’s ongoing business model transformation announced last year that focuses on recurring subscription-based revenue sources and new products. “This evolution and reinforcement of the Verimatrix governance structure aligns well with the company’s needs as we further the progression of our business model,” Amedeo D’Angelo said. “I look forward to working closely with Asaf in his newly expanded role as CEO during this strategic development of Verimatrix.” Previously leading the company’s R&D, product, sales and marketing operations, Asaf Ashkenazi will continue to harness his d

GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign28.7.2022 18:00:00 EEST | Press release

The new GUESS Fall-Winter 2022 advertising campaign sees the brand off to explore the history-steeped streets of Granada, Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005098/en/ GUESS Heads to Granada for the 2022 Fall/Winter Advertising Campaign (Photo: Business Wire) The FW22 campaign is immortalized through the lens of fashion photographer Tatiana Gerusova, under the guidance of GUESS?, Inc.’s Chief Creative Officer, Paul Marciano. The new campaign features a sizzling lineup: German-born, Polish fashion model Kim Dammer, Serbian model Nina Kostić, Spanish model Lidia Santos, Italian model Mario Ermito, and French model Xavier Grey. GUESS Women The campaign showcases an enticing array of GUESS pieces, highlighting must-have accessories and elevated animal and botanical prints. The collection brings a fresh and youthful breeze of contemporary color and style to grey winter days. Against the alluring continent

Innovaderm Bolsters European Presence With Two Newly-Established Operations Hubs (Spain & Poland)28.7.2022 17:00:00 EEST | Press release

Innovaderm announced today that its strategic European expansion initiative has reached a major milestone with the launch of two key centres of operations in Poland and Spain. Biotechnology and pharmaceutical companies can officially partner with the CRO’s team of experts in Europe to manage clinical trials in psoriasis, acne, atopic dermatitis and other dermatology indications. This includes adherence to stringent regulatory requirements, patient recruitment, site selection, clinical monitoring and protocol writing. “To date, we have successfully completed more than 500 clinical trials at 2,900 sites,” says Dave Selkirk, Innovaderm’s Chief Operating Officer. “The presence of two operations hubs in Europe will allow us to go one step further and accelerate the development of promising therapies that have the potential to transform lives. As we look to the future, our goal is to continue supporting innovation in research and the increasing number of patients with skin conditions worldwi

Echosens Partners with World Hepatitis Alliance on World Hepatitis Day, July 28, Urges Importance of Testing and Treatment28.7.2022 16:07:00 EEST | Press release

Echosens, a high-technology company offering liver diagnostic solutions, establishes its support of World Hepatitis Day (WHD), July 28 by partnering with the World Hepatitis Alliance as a bronze sponsor. The commemoration calls for greater awareness of the 357 million people who live with viral hepatitis but are unaware of it. The campaign’s theme “I can’t wait” highlights the need to accelerate the fight against viral hepatitis and the importance of testing and treatment for the real people who need it. “Echosens recognizes that every 30 seconds, someone in the world dies from a hepatitis-related illness, and we join hands with organizations throughout the world to advance increased vigilance around liver health,” says Dominque Legros, Echosens Group CEO. “It is gratifying to see that this year's theme for World Hepatitis Day aligns with our mission for early detection that can result in more effective intervention, treatment and better outcomes.” Viral hepatitis is an inflammation of

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