Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, and Orion Corporation (“Orion”) today announced that notice
has been provided of the mutual exercise of an option to convert
the companies’ ongoing co-development and co-commercialization
agreement for opevesostat (MK-5684/ODM-208), an investigational
CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an
exclusive global license for Merck.
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“We are pleased with the progress made to date in our
collaboration with Orion, including the initiation of two pivotal
Phase 3 trials evaluating opevesostat in certain patients with
metastatic castration-resistant prostate cancer,” said Dr. Dean Y.
Li, president, Merck Research Laboratories. “We will continue to
advance the clinical development program for opevesostat with speed
and rigor to help address the needs of patients living with
prostate cancer.”
“The conversion of this collaboration into a license agreement
allows Orion to focus our resources to progress our other promising
development candidates while both remaining well positioned to
benefit from the development and potential commercialization of
opevesostat and meeting our financial objectives,” said Liisa
Hurme, president and chief executive officer, Orion Corporation.
“We believe Merck provides the best choice to maximize the
potential of opevesostat, a compound discovered by Orion’s
scientists, for the treatment of patients with certain types of
prostate cancer.”
As previously announced under the companies’ original
co-development and co-commercialization agreement, each party was
granted an option to convert the co-exclusive license into an
exclusive global license for Merck. With the exercise of the
option, Merck will gain global exclusive rights to develop and
commercialize opevesostat and other candidates targeting CYP11A1
covered by the agreement.
Under the terms of the agreement, Orion is now eligible to
receive development milestone payments up to $30 million,
regulatory milestone payments up to $625 million and sales-based
milestone payments up to $975 million as well as annually tiered
royalty payments ranging from a low double-digit rate up to a rate
in the low twenties on net sales for any commercialized licensed
product. The development and regulatory milestones are determined
by the scope of a number of treatment indications and multiple
geographies. Annual sales exceeding several billion US dollars
would be required to reach the total amount of the sales milestones
and higher end of the royalty rate. In addition, as a result of the
exercise of the option, Merck will now assume full responsibility
for all past and future development and commercialization expenses
associated with the candidates covered by the agreement. As a
result of the option exercise and Merck’s assumption of expenses,
Orion announced it will release €60 million that was reserved in
July 2022 to cover Orion’s share of development cost to be accrued
from the balance sheet to net sales and operating profit in Q3
2024. Orion will retain responsibility for the manufacture of
clinical and commercial supply for Merck. No payment is associated
with the exercise of this option.
The exclusive global license is subject to approval under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
conditions, and is expected to become effective in the third
quarter of 2024.
About opevesostat and clinical trial program
Opevesostat is an oral, non-steroidal and selective inhibitor of
CYP11A1 discovered and developed by Orion and is being investigated
for the treatment of hormone-dependent cancers, such as prostate
cancer. By inhibiting CYP11A1 activity, opevesostat is designed to
suppress the production of all steroid hormones and their
precursors that may activate the androgen receptor signaling
pathway.
In 2023, Merck and Orion initiated OMAHA1 (NCT06136624) and
OMAHA2a (NCT06136650), two pivotal Phase 3 clinical trials
evaluating opevesostat in combination with hormone replacement
therapy (HRT), for the treatment of certain patients with
metastatic castration-resistant prostate cancer (mCRPC).
OMAHA1 is a randomized, open-label Phase 3 trial evaluating
opevesostat in combination with HRT for the treatment of patients
with later-line mCRPC who have failed one prior new hormonal agent
(NHA) and one or two prior taxanes compared to an alternative NHA
(abiraterone or enzalutamide). The trial will enroll an estimated
1,200 patients around the world. The primary endpoints are overall
survival (OS) and radiographic progression-free survival (rPFS) by
androgen receptor ligand-binding domain (AR LBD) mutation status.
Secondary endpoints include time to first subsequent therapy
(TFST), objective response rate (ORR) and duration of response
(DOR).
OMAHA2a is a randomized, open-label Phase 3 trial evaluating
opevesostat in combination with HRT for the treatment of patients
with front-line mCRPC who have failed one prior NHA compared to
physician’s choice of NHA (abiraterone or enzalutamide). The trial
will enroll an estimated 1,500 patients around the world. The
primary endpoints are OS and rPFS by AR LBD mutation status.
Secondary endpoints include TFST, ORR and DOR.
About metastatic castration-resistant prostate cancer
Prostate cancer is the second most common cancer in male
patients globally and is associated with a significant mortality
rate. Development of prostate cancer is often driven by male sex
hormones called androgens, including testosterone. In patients with
metastatic castration-resistant prostate cancer (mCRPC), their
prostate cancer grows and spreads to other parts of the body,
despite the use of androgen-deprivation therapy to block the action
of male sex hormones. Approximately 10-20% of patients with
prostate cancer are estimated to develop castration-resistant
prostate cancer (CRPC) within five years, with at least 84% of
these patients presenting with metastases at the time of CRPC
diagnosis. Of patients with no metastases at CRPC diagnosis, 33%
are likely to develop metastases within two years.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world - and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
About Orion
Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being for over a hundred years. We develop,
manufacture and market human and veterinary pharmaceuticals and
active pharmaceutical ingredients. Orion has an extensive portfolio
of proprietary and generic medicines and consumer health products.
The core therapy areas of our pharmaceutical R&D are oncology
and pain. Proprietary products developed by Orion are used to treat
cancer, neurological diseases and respiratory diseases, among
others. Orion's net sales in 2023 amounted to EUR 1,190 million and
the company had about 3,600 employees at the end of the year.
Orion's A and B shares are listed on Nasdaq Helsinki.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA
(the “company”) includes “forward-looking statements” within the
meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. 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 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; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company 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 the company’s Annual
Report on Form 10-K for the year ended December 31, 2023 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
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Merck Investor Contact: Peter Dannenbaum (732) 594-1579
Merck Media Contacts: Robert Josephson (203) 914- 2372
Justine Moore (347) 281-3754
Orion Investor Contact: Tuukka Hirvonen +358 10 426 2721
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