Medincell’s Partner Teva Provides Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI) and UZEDY® Commercial Progress
MedinCell's partner Teva has provided an update on the pivotal Phase 3 clinical trial of their investigational Olanzapine Long-Acting Injectable (LAI) and the commercial progress of UZEDY®. Key highlights include:
1. No Post-Injection Delirium/Sedation Syndrome (PDSS) observed after completion of approximately 95% of targeted injections for submission in the Olanzapine LAI Phase 3 trial.
2. Full Phase 3 safety results for Olanzapine LAI are on track for H2 2024, with positive efficacy results already announced in May 2024.
3. Teva is reaffirming UZEDY® revenue guidance for 2024 at approximately $80 million.
4. Teva is exploring an additional indication for UZEDY® for the treatment of Bipolar I Disorder in adults.
Il partner di MedinCell, Teva, ha fornito un aggiornamento sullo studio clinico cruciale di Fase 3 relativo al loro farmaco investigativo Olanzapina Long-Acting Injectable (LAI) e sui progressi commerciali di UZEDY®. Le principali novità includono:
1. Non sono stati osservati casi di Sindrome da Delirio/Sedazione Post-Iniezione (PDSS) dopo aver completato circa il 95% delle iniezioni previste per la presentazione della fase 3 dello studio sul LAI di Olanzapina.
2. I risultati di sicurezza completi della Fase 3 per Olanzapina LAI sono previsti per il secondo semestre del 2024, con risultati di efficacia già annunciati a maggio 2024.
3. Teva ha confermato le previsioni di fatturato per UZEDY® nel 2024, che si attestano approssimativamente su 80 milioni di dollari.
4. Teva sta esplorando un'ulteriore indicazione per UZEDY® per il trattamento del Disturbo Bipolare I negli adulti.
El socio de MedinCell, Teva, ha proporcionado una actualización sobre el ensayo clínico pivotal de Fase 3 de su investigacional Olanzapina de Acción Larga Injectable (LAI) y el progreso comercial de UZEDY®. Los aspectos más destacados incluyen:
1. No se observó el Síndrome de Delirio/Sedación Post-Inyección (PDSS) tras la finalización de aproximadamente el 95% de las inyecciones objetivo para la presentación en el ensayo de Fase 3 de Olanzapina LAI.
2. Los resultados de seguridad completos de la Fase 3 para Olanzapina LAI están en camino de ser anunciados en el segundo semestre de 2024, con resultados de eficacia positivos ya anunciados en mayo de 2024.
3. Teva está reafirmando la proyección de ingresos de UZEDY® para 2024 en aproximadamente 80 millones de dólares.
4. Teva está explorando una indicación adicional para UZEDY® para el tratamiento del Trastorno Bipolar I en adultos.
메딘셀의 파트너인 테바가 그들의 연구용 올란자핀 장기 작용 주사제(LAI) 임상 3상 시험과 UZEDY®의 상업적 진행 상황에 대한 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. 올란자핀 LAI 3상 시험 제출을 위한 목표 주사량의 약 95%를 완료한 후, 주사 후 섬망/진정 증후군(PDSS)은 관찰되지 않았습니다.
2. 올란자핀 LAI의 3상 안전성 완전 결과는 2024년 하반기를 목표로 하고 있으며, 2024년 5월에 이미 발표된 긍정적인 효능 결과가 있습니다.
3. 테바는 2024년 UZEDY® 수익 안내를 약 8000만 달러로 재확인하고 있습니다.
4. 테바는 성인의 제 1형 양극성 장애를 치료하기 위한 UZEDY®의 추가 적응증을 탐색하고 있습니다.
Le partenaire de MedinCell, Teva, a fourni une mise à jour sur l'essai clinique pivot de phase 3 de leur injectable à libération prolongée d'olanzapine (LAI) et sur les avancées commerciales d'UZEDY®. Les points clés incluent :
1. Aucun syndrome de délire/sédation post-injection (PDSS) n'a été observé après l'achèvement d'environ 95 % des injections prévues pour la soumission de l'essai de phase 3 de l'Olanza-pine LAI.
2. Les résultats de sécurité complets de la phase 3 pour l'Olanza-pine LAI sont attendus pour le second semestre 2024, avec des résultats d'efficacité positifs déjà annoncés en mai 2024.
3. Teva réaffirme les prévisions de chiffre d'affaires d'UZEDY® pour 2024 à environ 80 millions de dollars.
4. Teva explore une indication supplémentaire pour UZEDY® dans le traitement du trouble bipolaire de type I chez les adultes.
Der Partner von MedinCell, Teva, hat ein Update zur entscheidenden Phase-3-Studie seines experimentellen Langzeit-Depotpräparats Olanzapin (LAI) und zum kommerziellen Fortschritt von UZEDY® gegeben. Die wichtigsten Highlights sind:
1. Nach Abschluss von etwa 95 % der geplanten Injektionen zur Einreichung in der Phase-3-Studie zum Olanzapin LAI wurden keine Fälle von Post-Injektions-Deli-rium/Sedationssyndrom (PDSS) festgestellt.
2. Die vollständigen Sicherheitsforschungsergebnisse für Olanzapin LAI sind für das zweite Halbjahr 2024 auf Kurs, wobei bereits im Mai 2024 positive Wirksamkeitsergebnisse angekündigt wurden.
3. Teva bestätigt die Umsatzprognose für UZEDY® für 2024 mit etwa 80 Millionen US-Dollar.
4. Teva erkundet eine zusätzliche Indikation für UZEDY® zur Behandlung von bipolarer Störung I bei Erwachsenen.
- No Post-Injection Delirium/Sedation Syndrome (PDSS) observed in Olanzapine LAI Phase 3 trial after 95% of targeted injections
- Positive Phase 3 efficacy results for Olanzapine LAI announced in May 2024
- UZEDY® revenue guidance for 2024 reaffirmed at approximately $80 million
- Potential expansion of UZEDY® indications to include Bipolar I Disorder in adults
- None.
The update from Teva on MedinCell's long-acting injectable (LAI) olanzapine and UZEDY® presents significant developments in the company's pipeline and commercial progress. Let's break down the key points:
- Olanzapine LAI (mdc-TJK): The absence of Post-Injection Delirium/Sedation Syndrome (PDSS) in
95% of targeted injections is a important safety milestone. PDSS has been a major concern with LAI antipsychotics and this data could potentially give MedinCell's product a competitive edge in the market. - UZEDY® Commercial Progress: Teva's reaffirmation of
$80 million revenue guidance for 2024 indicates confidence in the product's market performance. This is particularly noteworthy for a relatively new product in the competitive antipsychotic market. - Potential Expansion: The exploration of UZEDY® for Bipolar I Disorder treatment could significantly expand its market potential, potentially doubling the addressable patient population.
From an investor's perspective, these developments are largely positive. The safety profile of olanzapine LAI, if maintained through full trial completion, could position it as a preferred option in its class. Meanwhile, UZEDY®'s commercial traction and potential label expansion present near-term revenue growth opportunities. However, it's important to note that full safety results for olanzapine LAI are still pending and the success of UZEDY®'s potential new indication is not guaranteed.
As a clinical psychiatrist, I find the developments in MedinCell's long-acting injectable (LAI) antipsychotics particularly intriguing. The absence of Post-Injection Delirium/Sedation Syndrome (PDSS) in the olanzapine LAI trial is a significant advancement. PDSS has been a major concern with LAI antipsychotics, particularly olanzapine, often limiting their use despite their potential benefits in improving medication adherence.
The exploration of UZEDY® for Bipolar I Disorder is also noteworthy. Long-acting formulations can be particularly beneficial in bipolar disorder, where medication adherence is often challenging due to the cyclical nature of the illness and periods of mania where insight may be impaired.
However, it's important to note that while these developments are promising, we must await the full safety profile of the olanzapine LAI. The
If these positive trends continue, MedinCell's products could potentially reshape our approach to long-term management of schizophrenia and bipolar disorder, offering new options for patients who struggle with daily oral medication regimens.
Olanzapine LAI (mdc-TJK)
-
No PDSS* observed after completion of c.
95% of the targeted injections for submission - Full phase 3 safety results on track for H2 2024
- Positive phase 3 efficacy results have already been announced in May 2024 (read the full PR)
UZEDY®
-
Reaffirming revenue guidance for 2024: c.
$80 million - Exploring an additional indication for UZEDY® for the treatment of Bipolar I Disorder in adults
MONTPELLIER,
Medincell (Paris:MEDCL):
About Olanzapine LAI Teva Pharmaceuticals, a
Olanzapine LAI is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine. It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of olanzapine have been associated with a FDA black box warning for PDSS that limits their use.
Christophe Douat, CEO of Medincell, commented: "Just eighteen months after the launch of Phase 3 of Olanzapine LAI, we already have positive efficacy results, and the full submission safety database is expected to be available before the end of year. For the first time, a long-acting injectable formulation of olanzapine may be widely used thanks to an unprecedented favorable safety profile made possible by Medincell technology.”
About UZEDY® (1-month and 2-month subcutaneous risperidone for treatment of schizophrenia), Teva reaffirmed revenue guidance of
UZEDY® is the first product based on Medincell's long-acting injection technology, BEPO®, that reached commercial stage.
-
US marketing authorization obtained from the
U.S. FDA on April 28, 2023, immediately followed by commercial launch by Teva in May 2023 -
€1.7 million of royalties already received by Medincell, calculated on Teva's net sales from mid-May 2023 to end of March 2024
About both partnered programs, Teva is fully responsible for leading the development and commercialization. Medincell may receive up to
*PDSS = Post injection Delirium/Sedation Syndrome
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in
UZEDY® and SteadyTeq™ are registered trademarks of Teva Pharmaceuticals.
This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities.
These statements may include, but are not limited to, any statements beginning with, followed by or including words or expressions such as "objective", "believe", "expect", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", "should", "could" and other words or expressions of similar meaning or used in the negative. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control which may cause actual results, performance or achievements of the Company to differ materially from those anticipated or implied by such statements.
A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in documents and reports to be published subsequently by the Company. Furthermore, these forward-looking statements only apply as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update these forward-looking statements, nor to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available. The Company's updating of one or more forward-looking statements does not imply that it will or will not update these or any other forward-looking statements.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240731557739/en/
David Heuzé - Head of Corporate and Financial Communications, and ESG
david.heuze@medincell.com / +33 (0)6 83 25 21 86
Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France
Louis-Victor Delouvrier/Alban Dufumier
medincell@newcap.eu / +33 (0)1 44 71 94 94
Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
Source: Medincell
FAQ
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