Rovi Receives Approval in the US to Market a Drug against Schizophrenia

Rovi has received approval from the United States Food and Drug Administration (FDA) for its drug Risvan as a treatment for schizophrenia in adults, as reported this Tuesday by the pharmaceutical company to the National Commission of the Market of Securities (Cnmv).

Specifically, the Spanish company announced this Tuesday that the FDA has authorized the marketing in the United States of Risvan (risperidone ISM) for the treatment of schizophrenia in adults .

Rovi shares soared almost 3% on the stock market around nine in the morning this Tuesday, after receiving approval from the FDA. The pharmaceutical company rose 2.73% on the Ibex 35 , until its shares were exchanged at a unit price of 82.8 euros.

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Rovi affirms that the new drug will improve adherence to treatment

Rovi has explained that the drug risperidone ISM is a prolonged-release injectable antipsychotic developed and patented by the pharmaceutical company for the treatment of schizophrenia in adults, which, from the first injection, provides plasma levels of the drug in an “immediate and sustained” manner. without requiring loading doses or supplementation with oral risperidone .

Thus, this approval is based on the positive results of the pivotal prisma-3 study on the efficacy and safety of risperidone ISM in patients with schizophrenia.

The firm has detailed that the results obtained in this study demonstrate that the pre-specified objectives in the key primary and secondary efficacy variables for the treatment of patients with moderate symptoms have been achieved with two different doses (75 and 100 milligrams monthly). severe symptoms of schizophrenia.

“We are very excited about the approval of Risvan by the FDA because we believe that our medicine will be able to contribute to the clinical management of schizophrenic patients, helping to improve adherence to treatment,” stressed the president and CEO of Rovi, Juan López. -Belmonte Encina.

Rovi plans to grow by selling its third party manufacturing business

Rovi plans to put the “for sale” sign on its third-party manufacturing business. The Spanish laboratory has commissioned the financial services firm Lazard to explore alternatives for its Cdmo division , an acronym in English for contract development and manufacturing organization. The idea of ​​the pharmaceutical company’s management would be to sell a significant portion of this area.

The agreement between Rovi and the American biotechnology company Moderna to produce the vaccine outside the United States led the Spanish company to go from billing 65.6 million euros in sales to third parties in 2019 to 403.5 million in 2023 , which increased the weight percentage of this division over total sales from 17.2% to 49.3%. This collaboration explains the Madrid laboratory’s commitment to doubling its production capacity in 2024.

The decision to explore a possible sale of the Cdmo division occurs in the context of Lazard’s advice since last summer to review from a strategic point of view the different areas of Rovi’s specialty, which in addition to third-party manufacturing include production of pharmaceutical specialties and research, development and innovation (R&D&I) services.

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