ODM-209

Orion provided more insight Monday concerning its shift into focusing on pain and oncology as the company moves forward, including its decision to cut 32 jobs. In March 2022, Orion announced that it planned to invest in new proprietary drugs in oncology and pain, denoting a shift away from its initial focus on therapeutics for rare and neurodegenerative diseases. The decision to move into these fields was fueled by the company’s interest in how active research and development for pain and oncological indications are. Funding for neurodegenerative and rare diseases was planned to be phased out while the company homed in on one of its core therapy areas, oncology. Now, the company has completed its negotiations under the Act on Co-operation within undertakings concerning the future of its research and development, making it official that it will be focusing on pain and oncology going forward. As a result, 32 working professionals within the company will be terminated, six of whom will be offered new positions elsewhere within Orion. Additionally, Orion will terminate the ongoing development of the indacaterol-glycopyrronium combined formulation for the treatment of chronic obstructive pulmonary disease (COPD). However, the company will continue to develop a new inhaled pulmonary drug which is a tiotropium formulation for the treatment of COPD in the European Market. A study is currently underway to evaluate bioequivalence and will be completed as planned. The company announced this month that it is entering into an agreement with Chinese company Jemincare for the development and commercialization of a selective NaV 1.8 blocker for the treatment of acute and chronic pain. As part of the agreement, Orion will receive exclusive global development and commercialization rights excluding the Greater China area and will receive ownership of certain key patent applications relating to the compound within its own territory. Orion also announced this month that the U.S. Food and Drug Administration accepted its supplemental New Drug Application (sNDA) and granted priority review for an additional indication of darolutamide, an oral androgen receptor inhibitor that inhibits the growth of prostate cancer cells. Darolutamide is already approved in more than 60 markets around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease. If approved, the sNDA would allow darolutamide in combination with docetaxel, a chemotherapeutic, to be used to treat patients with metastatic hormone-sensitive prostate cancer. Orion is also investigating another therapeutic for prostate cancer indications, ODM-208, which is currently in Phase II clinical trials and ODM-209 which is in Phase I clinical trials. The new shift in research and development will not impact the sale and distribution of any of Orion’s current pharmaceutical products including inhaled pulmonary drugs and those for neurological conditions. In April 2022, Orion shared its interim 2022 report which denoted a healthy net sales total of EUR 271 million and the company anticipates that its net sales for the remainder of 2022 will be in line with those from 2021.