Saturday, July 13, 2024

Merck Gains Global Rights to Opevesostat for Prostate Cancer

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Merck, also known as MSD outside the United States and Canada, and Orion Corporation have announced the mutual exercise of an option that grants Merck exclusive global rights to develop and commercialize Opevesostat for prostate cancer. This investigational CYP11A1 inhibitor targets metastatic castration-resistant prostate cancer (mCRPC).

Dr. Dean Y. Li, president of Merck Research Laboratories, expressed satisfaction with the collaboration’s progress. Two pivotal Phase 3 trials evaluating Opevesostat have been initiated. Merck will continue to advance the clinical development program rigorously to meet the needs of prostate cancer patients. Liisa Hurme, CEO of Orion, highlighted the strategic benefits of this agreement, allowing Orion to focus on other promising candidates. The exclusive license agreement is expected to maximize the potential of Opevesostat, a compound discovered by Orion’s scientists.

Under the agreement, Merck gains global exclusive rights to Opevesostat. Orion is eligible to receive development milestones up to $30 million, regulatory milestones up to $625 million, and sales-based milestones up to $975 million. Tiered royalty payments on net sales will also be provided. Merck will assume full responsibility for all development and commercialization expenses. Opevesostat is an oral, non-steroidal, selective inhibitor of CYP11A1, developed by Orion. It is designed to suppress steroid hormones and their precursors that activate the androgen receptor signaling pathway in hormone-dependent cancers like prostate cancer.

Phase 3 Trials: OMAHA1 and OMAHA2a

OMAHA1 and OMAHA2a are Phase 3 clinical trials evaluating Opevesostat in combination with hormone replacement therapy (HRT) for mCRPC. OMAHA1 focuses on patients who have failed one prior new hormonal agent (NHA) and one or two prior taxanes, while OMAHA2a targets patients who have failed one prior NHA. These trials aim to measure overall survival and radiographic progression-free survival. Prostate cancer is the second most common cancer in men globally, often driven by androgens like testosterone. mCRPC is an advanced stage where cancer grows despite androgen-deprivation therapy. Approximately 10-20% of prostate cancer patients develop mCRPC within five years, with significant mortality rates.

Merck, known as MSD outside the United States and Canada, is a leading research-intensive biopharmaceutical company. For over 130 years, Merck has developed important medicines and vaccines, aiming to improve lives globally. The company fosters a diverse, inclusive workforce and operates responsibly to ensure a sustainable future. Orion is a Finnish pharmaceutical company developing, manufacturing, and marketing human and veterinary pharmaceuticals. With a portfolio that includes proprietary and generic medicines, Orion focuses on oncology, pain, and other therapeutic areas. In 2023, Orion’s net sales reached EUR 1,190 million, employing about 3,600 people.

Prostate Cancer

Merck and Orion Advance Prostate Cancer Treatment

Merck’s announcement includes forward-looking statements subject to risks and uncertainties. The success of pipeline candidates depends on regulatory approvals and market conditions. Additional factors influencing results can be found in Merck’s annual reports and SEC filings. An ideal image for this news would feature scientists working collaboratively in a high-tech laboratory, examining molecular structures and bioreactors. The image should convey a sense of innovation and partnership, highlighting the groundbreaking work in cancer treatment.

This announcement marks a significant milestone in the fight against metastatic castration-resistant prostate cancer. The collaboration between Merck and Orion is set to advance the development of Opevesostat, offering new hope for patients globally. The exclusive license agreement reflects a strategic move to leverage both companies’ strengths in bringing innovative treatments to market.

The mutual exercise of the option for Merck to obtain global exclusive rights to Opevesostat underscores the commitment to advancing prostate cancer treatment. This collaboration is poised to make a significant impact, with clinical trials already underway and substantial financial milestones set. The health economics and market access landscape will benefit from these developments as new therapies reach patients in need.

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Resource: Merck, July 01, 2024

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