MONTPELLIER, France - Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), in collaboration with Medincell (Paris:MEDCL), has reported significant progress in the clinical development of Olanzapine LAI, a long-acting injectable treatment for schizophrenia. The company announced during its Q2 2024 earnings call today that approximately 95% of the targeted injections for regulatory submission have been completed with no cases of Post injection Delirium/Sedation Syndrome (PDSS) observed. .
Olanzapine LAI is being developed as a once-monthly subcutaneous injection using Medincell's BEPO® technology, which could potentially be the first such treatment without a black box warning for PDSS.
Medincell’s CEO, Christophe Douat, expressed optimism regarding the favorable safety profile enabled by their technology. The company also announced positive efficacy results for Olanzapine LAI earlier in May 2024, indicating a significant milestone in the drug's development.
In addition to Olanzapine LAI, Teva has reaffirmed its 2024 revenue guidance for UZEDY®, a product for schizophrenia treatment, at around $80 million. UZEDY®, also based on Medincell's BEPO® technology and marketed as SteadyTeq™ by Teva, received U.S. FDA approval on April 28, 2023, with commercialization beginning in May 2023. Since launch, Medincell has received €1.7 million in royalties from Teva's net sales.
Furthermore, Teva is exploring an additional indication for UZEDY® in the treatment of Bipolar I Disorder in adults, potentially widening its therapeutic applications.
Both Olanzapine LAI and UZEDY® are part of a partnership where Teva is responsible for development and commercialization. Medincell may receive up to $117 million in development and commercial milestones for Olanzapine LAI and up to $105 million for UZEDY® over the coming years, plus royalties on net sales.
InvestingPro Insights
Medincell (Paris:MEDCL) has shown a strong performance in the market, with a notable price uptick over the last six months and a significant return over the last year, as indicated by a 79.35% and 152.05% increase, respectively. These figures underscore the positive investor sentiment surrounding the company's clinical advancements and partnerships, particularly with Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) in the development of Olanzapine LAI, a promising treatment for schizophrenia.
InvestingPro data highlights Medincell's market capitalization at $514.92 million, with a revenue of $12.89 million over the last twelve months as of Q4 2024. Despite showing a decline in revenue growth during the same period, the company's stock has been resilient, trading at 91.31% of its 52-week high with a previous close price of $17.31. This resilience could be attributed to the market's confidence in Medincell's technology and its potential to generate future revenue streams through its collaboration with Teva.
According to InvestingPro Tips, analysts are not expecting Medincell to be profitable this year, which is consistent with the adjusted P/E ratio of -18.57. However, the company is trading at a high revenue valuation multiple, indicating that investors may be pricing in the potential for future growth and profitability. It's also worth noting that Medincell operates with a moderate level of debt, which may provide some financial flexibility as it continues to invest in its product pipeline.
For readers interested in a deeper dive into the financial health and future prospects of Medincell, InvestingPro provides additional tips that can be accessed through their platform. As of now, there are a total of 10 InvestingPro Tips available for Medincell, offering further insights into the company's performance and market expectations.
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