Teva Pharmaceutical Industries Limited (New York Stock Exchange: teva; level: 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 long-acting subcutaneous formulation of risperidone to use SteadyTeq, MedinCell’s proprietary copolymer technology that controls the sustained release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.
Richard Francis, Teva President and CEO, said, “UZEDY embodies Teva’s commitment to bringing innovative advances to patients and providing people with schizophrenia with an important new treatment option that is designed to address specific treatment challenges and may reduce the risk of relapse. The approval of UZEDY is the culmination of a multidisciplinary effort across Teva and MedinCell for bringing this important treatment to market. This milestone is testament to the development of our robust biopharmaceutical pipeline of innovative medicines aimed at supporting more people with mental health disorders and neurological diseases in the coming years.”
Christophe Douat, CEO of MedinCell, added: “The approval of the first product made with our technology is a pivotal moment for MedinCell and for the many patients who will benefit from it. We are committed to supporting patients with innovative treatment options. It is still an exciting journey. With Teva, the perfect partner to harness The full potential of UZEDY The arrival of our technology to the commercial stage marks the beginning of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all of our employees and shareholders.”
The bulk acquisition cost for UZEDY ranges from $1,232 to $3,080 per month depending on dosage strength. Actual costs for individual patients are expected to be lower than WAC because WAC does not take into account additional discounts and rebates that may apply. Teva is committed to helping patients who have been prescribed UZEDY access their medications and to providing Patient Support Professionals to assist with access, reimbursement, prescription withdrawals, and patient assistance. Savings in out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility to participate in the Copay Assistance Program.
UZEDY will be available in the US in the coming weeks.
Teva’s share price jumped 4.86% on TASE yesterday and rose another 0.76%. On Wall Street, the share price rose 2.46% on Friday to $8.43, which put the market cap at $9.697 billion. The share price rose another 0.92% in pre-market trading.
Published by Globes, Israel business news – en.globes.co.il – on May 1, 2023.
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