- 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
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Royalty Pharma plc (Nasdaq: RPRX), 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.
“Since launching Teva’s Pivot to Growth strategy in May 2023, we have been working on novel and expedited ways to both continue to invest in our robust innovative pipeline while supporting the growth of our in-line businesses,” said Richard Francis, President and CEO of Teva. “We are excited to collaborate with Royalty Pharma, a leading funder of innovation with a strong track record, experience, and reputation. This funding agreement enables us to continue to accelerate the development of olanzapine LAI (TEV-‘749), a critical program for us, without impacting resources dedicated to our innovative and generic medicines.”
"We are delighted to partner with Teva, to realize the potential of olanzapine LAI and support them as their innovative pipeline continues to come to fruition,” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. “Long-acting injectable antipsychotics improve compliance and can help prevent hospitalizations. Teva’s olanzapine LAI could be an important new treatment option for patients with schizophrenia.”
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.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative medicines research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at www.tevapharm.com.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly - directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT, Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s Trodelvy, and 12 development-stage product candidates.
Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to further accelerate the development and achieve expected results for olanzapine LAI (TEV-‘749), including our ability to commercialize olanzapine LAI (TEV-‘749); our ability to pay milestone payments under the funding agreement with Royalty Pharma; the risk that we will incur significant costs in connection with the development of olanzapine LAI (TEV-‘749), which may exceed any revenue generated by olanzapine LAI (TEV-‘749); risks that regulatory approvals and other requirements may delay the development and commercialization of olanzapine LAI (TEV-‘749); our ability to successfully launch and execute our new Pivot to Growth strategy including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our substantial indebtedness; our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in this press release, in our quarterly report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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