Teva and MedinCell's Long-Acting Risperidone Injection Expands Global Reach with Canadian Approval
核心洞察
Teva Canada Limited (搜索) received Health Canada approval for LONGAVO (搜索)®, a long-acting injectable risperidone formulation using MedinCell (搜索)'s BEPO® technology for treating schizophrenia (搜索) in adults.
The approval marks the third major market authorization for the risperidone LAI, following successful launches in the United States as UZEDY® and South Korea.
UZEDY® has demonstrated strong commercial performance with $117 million in net sales in 2024 and $95 million in the first half of 2025 following its US approval in May 2023.
Teva Canada Limited (搜索) has received regulatory approval from Health Canada for LONGAVO (搜索)®, a long-acting injectable formulation of risperidone developed using MedinCell (搜索)'s proprietary BEPO® technology for the treatment of schizophrenia (搜索) in adults. The approval represents a significant milestone in the global expansion of this innovative antipsychotic treatment.
Strong Commercial Performance Drives International Expansion
The Canadian approval follows the successful launch of the same formulation in the United States, where it is marketed as UZEDY® by Teva (搜索). Since its US approval in May 2023, UZEDY® has demonstrated robust commercial performance, generating $117 million in net sales in 2024 and already achieving $95 million in sales during the first half of 2025.
The treatment has now secured regulatory approval in three major markets: the United States, South Korea, and Canada. In South Korea, the medication received approval from the Ministry of Food and Drug Safety and will be distributed by Teva Handok (搜索), a joint venture between Teva (搜索) and Handok (搜索), a leading South Korean healthcare company.
Proprietary BEPO® Technology Enables Extended Release
The risperidone long-acting injectable combines the established antipsychotic medication with MedinCell (搜索)'s proprietary BEPO® technology, which enables controlled drug delivery at therapeutic levels for extended periods following subcutaneous or local injection. The technology utilizes a small, fully bioresorbable deposit that can maintain therapeutic drug levels for several days, weeks, or months.
Christophe Douat, CEO of MedinCell (搜索), emphasized the significance of the South Korean approval, stating: "We are delighted to see UZEDY® receive regulatory approval in South Korea, further strengthening the strong commercial momentum observed in the United States since its launch in 2023. More patients living with schizophrenia (搜索) will now be able to benefit from UZEDY® and its unique features, which position it as the treatment of choice."
Financial Structure and Future Milestones
Under the partnership agreement, MedinCell (搜索) receives mid- to high-single digit royalties on all worldwide sales of the risperidone LAI formulation. The company remains eligible for up to $105 million in commercial milestone payments as the product continues its global rollout.
The first treatment based on BEPO® technology received FDA approval for schizophrenia (搜索) in April 2023, with the technology licensed to Teva (搜索) under the name SteadyTeq™. This initial success has paved the way for the current international expansion strategy.
About the Companies
MedinCell (搜索) operates as a clinical- and commercial-stage biopharmaceutical licensing company focused on developing long-acting injectable treatments across multiple therapeutic areas. The company's innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.
Headquartered in Montpellier, France, MedinCell (搜索) employs over 140 people representing more than 25 nationalities. The company collaborates with leading pharmaceutical companies and foundations to advance global health through new treatment options, with an investigational pipeline that includes numerous therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials.