Orion ends ODM-111 development due to narrow therapeutic window

ORION CORPORATION STOCK EXCHANGE RELEASE – INSIDE INFORMATION 
24 OCTOBER 2024 at 19.50 EEST

Orion Corporation has announced the termination of its ODM-111 development program. This decision follows a risk-benefit analysis from an extended non-clinical toxicology study which suggested that the molecule is not suitable for long-term use and further development. Despite earlier non-clinical studies and a Phase I clinical trial indicating no significant safety concerns with shorter durations of exposure, the latest data revealed that the therapeutic window of ODM-111 is too narrow to justify its continued development.

Outi Vaarala, Senior Vice President of Innovative Medicines and Research & Development at Orion, stated, “Although preparations for Phase II trials were well underway, we have determined that the therapeutic window of ODM-111 is too narrow, making the continuation of its clinical development program unfeasible. We are redirecting our focus and resources towards other promising projects within our R&D pipeline.”

The announcement of this decision was made public in a stock exchange release due to the strategic importance of ODM-111. This marks an unusual step for Orion, which typically discloses information on R&D projects in its interim reports or press releases, reserving separate stock exchange releases for results from Phase III clinical trials.

Orion is a Finnish pharmaceutical company with a century-long history of contributing to global well-being. They are involved in the development, manufacturing, and marketing of human and veterinary pharmaceuticals as well as active pharmaceutical ingredients. The company boasts a diverse portfolio of proprietary and generic medicines, along with consumer health products. Orion's research and development efforts are primarily focused on oncology and pain management, with proprietary products treating conditions such as cancer, neurological diseases, and respiratory disorders. In 2023, Orion's net sales totaled EUR 1,190 million, and the company employed approximately 3,600 people by the end of the year. 

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