Organon and Cirqle Biomedical Enter Research Collaboration and License Agreement for Investigational Non-hormonal, On-demand Contraceptive Candidate
July 28 2022 - 7:30AM
Business Wire
Collaboration continues to expand portfolio in
women’s health to help address unmet needs
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.
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“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).
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version on businesswire.com: https://www.businesswire.com/news/home/20220728005145/en/
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
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