Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and MedinCell (Euronext: MEDCL) have announced that the US Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.
Teva president and CEO Richard Francis said, "UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse. The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years."
MedinCell CEO Christophe Douat added, "The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit. We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders."
The Wholesale Acquisition Cost for UZEDY ranges from $1,232 to $3,080 per month depending on dosage strength. Actual costs for individual patients are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Teva is committed to helping patients who have been prescribed UZEDY access their medication and provide patient support specialists to help with access and reimbursement, prescription pull-through and patient assistance. Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program.
UZEDY will be available in the US in the coming weeks.
Teva's share price jumped 4.86% on the TASE yesterday and is up a further 0.76%. On Wall Street the share price rose 2.46% on Friday to $8.43, giving a market cap of $9.697 billion. The share price is up a further 0.92% in premarket trading.
Published by Globes, Israel business news - en.globes.co.il - on May 1, 2023.
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