On May 29, 2024, Johnson and Johnson announced positive results from the pivotal Phase 3 MDD3001 clinical trial of seltorexant as an adjunctive treatment to baseline antidepressants in adult and elderly patients with major depressive disorder (“MDD”) with insomnia symptoms. Seltorexant, a potential first-in-class selective antagonist of the human orexin-2 receptor, met all primary and secondary endpoints in the study, and was also safe and well-tolerated. These results were observed in a patient population that was assessed to be moderately-to-severely depressed despite ongoing treatment with SSRI/SNRIs and suffered from significant sleep disturbance. Currently, there are no approved therapies to treat MDD with insomnia symptoms. The findings of this study will be presented at this year’s American Society of Clinical Psychopharmacology Annual Meeting,
Royalty Pharma plc (the “Company”) is entitled to a mid-single digit royalty on worldwide net sales of seltorexant. Johnson and Johnson, at their December 2023 Enterprise Business Review, stated that seltorexant has the potential for non-risk adjusted peak sales of between $1 billion and $5 billion.
Forward-Looking Statements
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This Form 8-K contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “target,” “forecast,” “guidance,” “goal,” “predicts,” “project,” “potential” or “continue,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this Form 8-K are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.