- Royalty Pharma to provide R&D funding support of up to $125 million for the development of olanzapine LAI (TEV-‘749), a long-acting subcutaneous injectable olanzapine for schizophrenia
- Phase 3 data expected in the second half of 2024
NEW YORK, NY, and TEL AVIV, ISRAEL, November 13, 2023 – Royalty Pharma plc (Nasdaq: RPRX) and Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today a collaboration to further accelerate the clinical research program for Teva’s olanzapine LAI (TEV-‘749) by entering into a funding agreement of up to $125 million to offset program costs. Olanzapine LAI (TEV-‘749) is a once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine that is currently in Phase 3 for the treatment of schizophrenia and has the potential to be the first long-acting olanzapine with a favorable safety profile.
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Transaction Terms
Under the agreement, Royalty Pharma will provide Teva up to $100 million to fund ongoing development costs for olanzapine LAI (TEV-‘749), and Royalty Pharma and Teva have a mutual option to increase the total funding amount to $125 million. Upon U.S. Food and Drug Administration (“FDA”) approval, Teva will pay Royalty Pharma the total amount funded over five years, as well as low to mid-single digit royalties upon commercialization. If Teva chooses not to file a New Drug Application with the FDA following positive Phase 3 study results, then Teva will pay an amount equal to 125% of the total amount funded. Teva will lead the development and commercialization of olanzapine LAI (TEV-‘749) globally.
About olanzapine LAI (TEV-‘749)
TEV-‘749 (olanzapine) extended-release injectable suspension, for subcutaneous use rather than intramuscular use, is the second product developed by Teva to utilize SteadyTeq™, a copolymer technology proprietary to MedinCell S.A. that allows for sustained release of olanzapine at a therapeutic dose over the full one-month dosing interval. SteadyTeq is also utilized in UZEDY™ (risperidone) extended-release injectable suspension for subcutaneous use, which was approved by the FDA for the treatment of schizophrenia in adults in April 2023. In the third quarter of 2022, Teva progressed the development of olanzapine LAI (TEV-‘749) to Phase 3, and Phase 3 data on olanzapine LAI are now expected in the second half of 2024.
Teva leads the clinical development and regulatory process and is responsible for commercialization of these products.
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This text is a press release from Royalty Pharma. The full text version of the article can be found here.
