Merck and Orion Announce Global Collaboration for the Development and Commercialization of ODM-208, an Investigational Steroid Synthesis Inhibitor for the Treatment of Metastatic Castration-Resistant Prostate Cancer
July 13 2022 - 6:00AM
Business Wire
Orion to receive an upfront payment of USD
290 million
Agreement strengthens and complements
Merck’s oncology pipeline
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Orion Corporation (“Orion”) today announced a global
development and commercialization agreement for Orion’s
investigational candidate ODM-208 and other drugs targeting
cytochrome P450 11A1 (CYP11A1), an enzyme important in steroid
production. ODM-208 is an oral, non-steroidal inhibitor of CYP11A1
currently being evaluated in a Phase 2 clinical trial for the
treatment of patients with metastatic castration-resistant prostate
cancer (mCRPC).
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Under the terms of the agreement, Orion and Merck, acting
through its subsidiary, Merck Sharp & Dohme LLC, will
co-develop and co-commercialize ODM-208. Merck will make an upfront
payment to Orion of USD 290 million, which will be expensed by
Merck in the third quarter of 2022 and included in non-GAAP
results. Of this upfront payment, Orion recognizes approximately
EUR 220 million as income at the time of signing and approximately
EUR 60 million is reserved to cover Orion’s share of ODM-208
development cost to be accrued in the future. Orion will be
responsible for the manufacture of clinical and commercial supply
of ODM-208.
In addition, the contract provides both parties with an option
to convert the initial co-development and co-commercialization
agreement into a global exclusive license to Merck. If the option
is exercised, Merck would assume full responsibility for all
accrued and future development and commercialization expenses
associated with the program. Orion would be eligible to receive
milestone payments associated with progress in the development and
commercialization of ODM-208 as well as tiered double-digit
royalties on sales if the product is approved. The total amount
potentially accrued from multiple regulatory and sales milestone
events represents a substantial opportunity for Orion.
“Targeting CYP11A1 provides a compelling approach to suppressing
the production of steroid hormones, a key driver of prostate
cancer,” said Dr. Dean Y. Li, president, Merck Research
Laboratories. “We believe ODM-208 has the potential to complement
our existing program in prostate cancer and look forward to working
with the team at Orion.”
“We are delighted to enter this collaboration with Merck, which
is committed to extend and improve the lives of patients with
cancer and has a strong commercial presence globally,” said Timo
Lappalainen, president and chief executive officer, Orion. “This
agreement positions Orion to harness the potential of ODM-208 for
the good of patients while continuing to invest in our other
programs without compromising our financial targets.”
About ODM-208
ODM-208 is an oral, non-steroidal and selective inhibitor of the
CYP11A1 enzyme discovered and developed by Orion for the treatment
of hormone-dependent cancers, such as prostate cancer. By
inhibiting CYP11A1 enzyme activity, ODM-208 is designed to suppress
the production of all steroid hormones and their precursors that
may activate the androgen receptor signaling pathway.
About Metastatic Castration-Resistant Prostate Cancer
Globally, prostate cancer is the second most common cancer in
people assigned male at birth, with an estimated 1.4 million
patients diagnosed worldwide in 2020. Approximately 10-20% of
patients with advanced prostate cancer are estimated to develop
CRPC within five years, and at least 84% of these patients may
develop metastases at the time of CRPC diagnosis. Patients with
advanced prostate cancer have a particularly poor prognosis, and
the five-year survival rate remains low.
About Orion
Orion is a globally operating Finnish pharmaceutical company – a
builder of well-being. Orion develops, manufactures and markets
human and veterinary pharmaceuticals and active pharmaceutical
ingredients. The company is continuously developing new drugs and
treatment methods. The core therapy areas of Orion's pharmaceutical
R&D are oncology and pain. Orion's net sales in 2021 amounted
to EUR 1,041 million and the company had about 3,350 employees at
the end of the year. Orion's A and B shares are listed on Nasdaq
Helsinki.
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
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 the global outbreak of novel coronavirus disease
(COVID-19); 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, 2021 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: Peter Dannenbaum (908) 740-1037
Merck Media: Melissa Moody (215) 407-3536
Ian McConnell (908) 740-1921
Orion: Tuukka Hirvonen +358 10 426 2721
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