Medincell Appoints Dr Grace Kim, Chief Strategy Officer, U.S. Finance, to Advance into Next Stage of US Capital Growth
Medincell, a clinical-stage pharmaceutical company pioneering long-acting injectable therapies, today announced the expanded role of Dr Grace Kim, Chief Strategy Officer, U.S. Finance.
Medincell to Join MSCI World Small Cap Index, a Leading Global Benchmark
Medincell has been selected for inclusion in the Morgan Stanley Capital International (MSCI) World Small Cap Index, which encompasses the most liquid and high-performing small-cap companies across 23 developed markets.
Medincell to Join the Euronext SBF 120 Index
Medincell (Paris:MEDCL) joins the Euronext SBF 120 index, which includes the 120 largest companies listed on Euronext Paris, including the CAC 40 and most of the key players in the French economy. Medincell joins also the CAC Mid 60 index.
Medincell and AIC Unveil New Positive Phase 3 Results for mdc-CWM: Major Subgroup Analysis Shows Reduced Pain and Opioid Use, and Accelerated Rehabilitation following Total Knee Replacement
Analysis of a major subgroup of patients undergoing a first Total Knee Replacement (TKR), representing over 70% of the trial population (108 out of 151), revealed the following benefits when comparing patients treated with F14/mdc-CWM (n=51) to those in the control group (n=57)1:
Medincell’s Partner Teva Provided Treatment Insights into Switching to UZEDY® from Perseris®
New data presented by Teva at ECNP 2024* demonstrate switching to UZEDY at four weeks after the last dose of once-monthly Perseris® (RBP-7000) provided the most comparable pharmacokinetic (PK) profile based on relevant simulations, with comparable doses identified.
Medincell’s Partner Teva Presented New Efficacy, Safety, and Tolerability Data from Pivotal Phase 3 of Olanzapine LAI for Adult Patients Diagnosed with Schizophrenia
Teva presented at ECNP 2024* new positive efficacy, safety, and tolerability results for Phase 3 SOLARIS trial evaluating Olanzapine LAI (TV-‘749 / mdc-TJK) in adult patients diagnosed with schizophrenia.
Medincell’s Partner Teva Provides New Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI)
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced during the 22nd Annual Global Healthcare Conference held yesterday that c.99% of the targeted injections for submission have been performed as of today (replay available here). Teva also confirmed that the full submission safety results are expected to be available in H2 24.
Medincell Enters Into Strategic Co-development and Licensing Agreement with AbbVie to Develop Next-generation Long-acting Injectable Therapies
Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.
Unitaid Awards Medincell up to $6 million Extension Grant to Fight Malaria
Global health agency Unitaid has awarded Medincell (Paris:MEDCL) an extension grant of up to US$ 6 million over three years to fund the clinical phase 1 activities of long-acting injectable mdc-STM. If proven safe, effective, and acceptable, mdc-STM could have a significant impact on transmission of malaria among vulnerable populations in high-transmission areas.
MedinCell’s partner Teva Announces Recruitment Completion of Phase 3 Clinical Study of mdc-TJK / Olanzapine Long-Acting Injectable (LAI)
Teva Pharmaceutical Industries Ltd. announced the successful completion of the enrollment in the EU and US of the anticipated 640 participants of the ongoing Phase 3 clinical trial of mdc-TJK (TEV-44749) at the J.P. Morgan Healthcare Conference. Results of the study are expected in the second half of 2024.1
MedinCell announces successful completion of patient enrollment in the Phase 3 study of F14 (mdc-CWM), a first-in-class therapy for localized pain relief after Total Knee Replacement
MedinCell today announces that its partner, Arthritis Innovation Corporation (AIC), who conducts and finances all development activities of F14 (MedinCell codename: mdc-CWM), has completed the patient enrollment in the first of two Phase 3 clinical studies of F14 in patients undergoing total knee replacement (TKR). F14 (mdc-CWM) is a sustained-release formulation of the non-steroidal anti-inflammatory drug (NSAID), celecoxib, administered into the intra-articular space at the end of TKR surgery.
MedinCell: mdc-TJK's (Teva's codename: TEV-44749) Phase 1 study pharmacokinetics to be presented for the first time by Teva at SIRS 2023 (May 11-15, 2023, Toronto, Canada)
An original presentation describing pharmacokinetic characteristics of an investigational long-acting subcutaneous formulation of olanzapine (mdc-TJK or TEV-44749) will be communicated by MedinCell’s partner Teva Pharmaceuticals at the 2023 Schizophrenia Investigational Research Society (SIRS) later this month.
Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that 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 6-24 hours of a single dose.1
Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)
The Phase 3 study conducted in the U.S. will assess the efficacy and safety of the first subcutaneous long-acting Injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia.
MedinCell announces positive results for the SAIVE clinical study in prevention of Covid-19 infection in a contact-based population
The study conducted in 399 participants met its primary efficacy endpoint with a reduction of 72% of COVID-19 infection in the group treated with daily oral administration of ivermectin compared to the placebo group.
France : EIB and MedinCell Sign a New €40 Million Loan Agreement to Support Development of Innovative Treatments
The new loan signed between the European Investment Bank (EIB), backed by the Investment Plan for Europe, and pharmaceutical company MedinCell (Paris:MEDCL) is intended to support the development of the company’sportfolio of innovative treatments of the company. MedinCell’s portfolio is already composed of several Long-Active injectable products at preclinical and clinical stage. A first product using MedinCell’s BEPO® technology is expected to reach the U.S. market in the first half of 2023.
MedinCell announces the initiation of Phase 3 study of F14 (mdc-CWM), a therapeutic first-in-class that aims to provide weeks of localized pain relief after Total Knee Replacement
MedinCell (Paris:MEDCL) today announced that its partner, Arthritis Innovation Corporation (AIC), who conducts and finances all development activities of F14 (MedinCell codename: mdc-CWM), has registered its multicenter, randomized, double blind Phase 3 safety and efficacy study on the public trials registry, clinicaltrials.gov. Enrollment of first patients is expected this month.
MedinCell’s Partner Teva Today Announced Refiling for Approval of mdc-IRM and Confirmed Planned Launch in the U.S. in H1 2023
MedinCell’s (Paris:MEDCL) partner, Teva, today announced that it recently completed the re-submission to a New Drug Application to the U.S. FDA for mdc-IRM, a risperidone subcutaneous Long-Acting Injectable (LAI) for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology.
MedinCell Signs a Licence Agreement With the Medicines Patent Pool to Fight Malaria Transmission, as Part of Its Global Health Mission
The licence agreement complements the collaboration between Medincell and the health agency Unitaid that funds the development of mdc-STM, an investigational long-acting injectable formulation for the prevention of malaria.
Phase 3 Study to Be Initiated for Second Long-acting Injectable Antipsychotic Using MedinCell’s Technology
Teva Pharmaceuticals has notified MedinCell (Paris:MEDCL) that it made the decision to initiate the clinical Phase 3 trial for mdc‑TJK.
An Impact Company Committed to Improving the Health of Patients Worldwide, MedinCell Publishes Its 2021-2022 ESG Annual Report
MedinCell's annual ESG report goes into detail on the different pillars of its ESG policy, its implementation through concrete and clearly defined objectives, and the evolution of the company's extra-financial data.
MedinCell: US Pharma Development Expert Richard Malamut, MD Becomes Chief Medical Officer
"After working as an active member of the Medical Advisory Board of MedinCell, I am delighted to be joining full time the company as a CMO at a time when its first product is in the final stage of the FDA approval process. I look forward to contribute to the success of the other programs in MedinCell’s pipeline.
MedinCell’s breakthrough technology allows for significant clinical improvements to existing medications and will provide meaningful benefits to patients across a broad range of therapeutic indications," said Dr Malamut.
MedinCell provides additional information regarding the new drug application for MDC-IRM
As announced, Teva recently received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM.
Phase 3 Data of mdc-IRM, First Product Based On MedinCell’s Technology, Shows Significant Improvements in Patients With Schizophrenia:
Developed in collaboration with Teva Pharmaceuticals, mdc-IRM, a risperidone extended-release injectable suspension for the treatment of patients with schizophrenia (Teva codename: TV-46000), is the most advanced investigational product based on MedinCell’s BEPO® technology. Ongoing New Drug Application review by FDA could lead to commercialization as early as 2022 in the U.S. by Teva, provided marketing authorization. MedinCell is eligible for development and commercial milestones ($122 million), and royalties on net sales.
MedinCell Announces Participation in the Jefferies London Healthcare Conference 2021
MedinCell will be attending the 12th Jefferies London Healthcare Conference on Tuesday, November 16 and Wednesday, November 17 at the Waldorf Hilton in London.
MedinCell: mdc-IRM’s Phase 3 Data to Be Presented for the First Time by Teva at Psych Congress 2021 (Oct. 29-Nov. 1, 2021, San Antonio, USA)
mdc-IRM [Teva’s codename: TV46000], a subcutaneous risperidone injectable suspension for the treatment of patients with schizophrenia, is the most advanced investigational product based on MedinCell’s (Paris:MEDCL) BEPO® technology.
MedinCell Provides an Update on Its Product Portfolio, Following the FDA Acceptance of New Drug Application for the Product mdc-IRM
MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia.
Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA).
MedinCell’s Long-Acting Injectable to Fight Malaria Ready to Enter Regulatory Development
MedinCell and the consortium members have conducted an in vivo proof of concept on cattle that showed a 3-month mosquitocidal effectiveness of an injectable long-acting formulation of Ivermectin based on the proprietary BEPO® technology.
Clinical Trial Conducted by MedinCell Confirms the Safety of Continuous Administration of Ivermectin
Clinical trial validates the safety of ivermectin taken daily in oral form, to simulate the continuous release of the active substance by a long-acting injection.
