Inside information: Orion and MSD Announce Mutual Exercise of Option Providing MSD Global Exclusive Rights to Opevesostat, an Investigational CYP11A1 Inhibitor, for the Treatment of Metastatic Castration-Resistant Prostate Cancer
July 01 2024 - 8:15AM
ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION1
JULY 2024 at 15:15 EEST
Inside
information: Orion and MSD Announce Mutual Exercise of Option
Providing MSD Global Exclusive Rights to Opevesostat, an
Investigational CYP11A1 Inhibitor, for the Treatment of Metastatic
Castration-Resistant Prostate Cancer
Orion Corporation (“Orion”) and MSD (Merck & Co., Inc.,
Rahway, NJ, USA) 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
MSD.
“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 commercialisation of
opevesostat and meeting our financial objectives,” said
Liisa Hurme, President & CEO of Orion
Corporation. “We believe MSD provides the best choice to maximise
the potential of opevesostat, a compound discovered by Orion’s
scientists, for the treatment of patients with certain types of
prostate cancer.”
“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, MSD 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.”
As previously announced, under the companies’ original
co-development and co-commercialisation agreement each party was
granted an option to convert the co-exclusive license into an
exclusive global license for MSD. With the exercise of the option,
MSD will gain global exclusive rights to develop and commercialise
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 USD 30 million,
regulatory milestone payments up to USD 625 million and sales-based
milestone payments up to USD 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 commercialised 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, MSD will now assume full responsibility for
all past and future development and commercialisation expenses
associated with the candidates covered by the agreement. As a
result of the option exercise and MSD’s assumption of expenses,
Orion announced it will release EUR 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 MSD. 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, Orion and MSD 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 randomised, 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 randomised, 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 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.
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.msd.com and connect with us
on X (formerly
Twitter), LinkedIn and YouTube.
Orion Corporation
Liisa
HurmePresident and CEO |
|
Outi VaaralaSVP,
Innovative Medicines and Research & Development |
|
Contact
person:Tuukka Hirvonen, Investor Relations, Orion
Corporationtel. +358 10 426 2721
Contact person for the
media:
Terhi Ormio, Vice President, Communicationstel. +358 10 426
4646
Publisher:Orion
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