Inside information: Orion terminates ODM-111 development program due to narrow therapeutic window of the molecule
24 Oktober 2024 - 6:50PM
UK Regulatory
Inside information: Orion terminates ODM-111 development program
due to narrow therapeutic window of the molecule
ORION CORPORATION
STOCK EXCHANGE RELEASE – INSIDE INFORMATION
24 OCTOBER 2024 at 19.50 EEST
Inside information: Orion terminates ODM-111 development
program due to narrow therapeutic window of the
molecule
Orion Corporation has decided to terminate the ODM-111
development program based on the risk-benefit analysis on the
results of a longer non-clinical toxicology study. Recent findings
indicate that the profile of the ODM-111 molecule does not support
long-term use of ODM-111 and progression to later-stage
development. Additionally, it is important to note that both prior
non-clinical studies and the clinical Phase I trial with shorter
durations of exposure to ODM-111 did not reveal any significant
safety concerns.
“Although preparations for the Phase II trials were already well
underway, we have now evaluated that the therapeutic window of
ODM-111 is too narrow and continuation of the clinical development
program for ODM-111 is not feasible for Orion. We are now focusing
our resources on other promising projects in our R&D pipeline”,
said Outi Vaarala, Senior Vice President,
Innovative Medicines and Research & Development at Orion.
Exceptionally, Orion publishes information about a project in
early clinical development stage in a stock exchange release,
because in this case, the information is estimated to meet the
definition of inside information due to ODM-111’s strategic
importance. This does not affect Orion's current disclosure policy,
according to which Orion publishes information on its R&D
projects mainly in its interim reports and/or press releases, but,
as a main rule, provides information on the results of clinical
Phase III trials in separate stock exchange releases.
Orion Corporation
Liisa Hurme
President and CEO |
|
Olli Huotari
SVP, Corporate Functions |
|
Contact person:
Tuukka Hirvonen, Investor Relations
tel. +358 10 426 2721
Contact person for the media:
Terhi Ormio, VP, Communications
Tel. +358 10 426 4646
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orion.fi/en
http://www.twitter.com/OrionCorpIR
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.
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