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Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell have announced the U.S. 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 six to 24 hours of a single dose. UZEDY is the first product based on MedinCell’s proprietary BEPO technology (licensed to Teva under the name SteadyTeq) to reach market. “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,” said Richard Francis, president and CEO of Teva. “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.” Multiple relapses Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology. Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts. The approval is based on data from two phase 3 trials evaluating UZEDY in patients with schizophrenia: TV46000-CNS-30072 (the RISE study), and TV46000-CNS-30078 (the SHINE study). "The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell. “We now have a product reaching market with significant commercial potential in the U.S.. Given UZEDY’s differentiating features and positive phase 3 results, we believe it has the potential to establish a new standard of care for patients with schizophrenia. This major development in the evolution of our company will benefit all the products of our portfolio and increase our visibility. Our team and our partner have done an exceptional job together. This success goes beyond MedinCell, it is also major news for the French biotechnology sector.” UZEDY: a new treatment option “Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia, so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, professor of psychiatry at the Zucker School of Medicine, Hempstead, U.S. “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.” 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. UZEDY will be available in the U.S. in the coming weeks. MedinCell technology Two other products based on the same MedinCell's BEPO technology are currently in phase 3 and several others are in development. Jaime Arango, chief financial officer of MedinCell said: “We are reaching the commercial stage with an ideal partner to exploit the full potential of UZEDY. Teva is building a schizophrenia franchise. Its American sales force has recently demonstrated its effectiveness on the same target of prescribers as UZEDY. We are entitled to receive royalties from the first sales and eligible for up to $105 million in commercial milestones in the coming years. In the short term, this approval triggers a $4 million payment from Teva to MedinCell and gives us access to the third tranche of the EIB loan for an amount of €10 million ($11 million).”

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