Medincell’s Partner Teva Provides New Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI)
Teva Pharmaceuticals has provided an update on the pivotal Phase 3 clinical trial of its investigational Olanzapine Long-Acting Injectable (LAI). The company announced that approximately 99% of the targeted injections for submission have been completed, with no Post-Injection Delirium/Sedation Syndrome (PDSS) observed. Teva confirmed that full phase 3 safety results are expected in H2 2024, following the positive efficacy results announced in May 2024.
Olanzapine LAI is being developed as a once-monthly subcutaneous injection for atypical antipsychotic treatment. It has the potential to be the first long-acting Olanzapine with a favorable safety profile, as other LAIs of Olanzapine have FDA black box warnings for PDSS. Teva's partner, Medincell, may receive up to $117 million in milestones and royalties on net sales.
Teva Pharmaceuticals ha fornito un aggiornamento sul cruciale trial clinico di fase 3 del suo investigational Olanzapina a lunga durata d'azione (LAI). L'azienda ha annunciato che circa 99% delle iniezioni programmate per la presentazione sono state completate, senza che sia stato osservato Sindrome da Delirio/Sedazione Post-Iniezione (PDSS). Teva ha confermato che i risultati completi sulla sicurezza di fase 3 sono previsti per il secondo semestre del 2024, a seguito dei risultati positivi di efficacia annunciati a maggio 2024.
Olanzapina LAI è in fase di sviluppo come iniezione sottocutanea mensile per il trattamento degli antipsicotici atipici. Ha il potenziale per essere la prima Olanzapina a lunga durata con un profilo di sicurezza favorevole, poiché altre LAI di Olanzapina hanno avvertenze nella scatola nera della FDA per PDSS. Il partner di Teva, Medincell, potrebbe ricevere fino a 117 milioni di dollari in traguardi e royalties sulle vendite nette.
Teva Pharmaceuticals ha proporcionado una actualización sobre el crucial ensayo clínico de fase 3 de su Olanzapina de liberación prolongada (LAI) investigacional. La compañía anunció que aproximadamente 99% de las inyecciones programadas para la presentación se han completado, sin que se haya observado Síndrome de Delirio/Sedación Post-Inyección (PDSS). Teva confirmó que los resultados completos de seguridad de fase 3 se esperan para la segunda mitad de 2024, tras los resultados positivos de eficacia anunciados en mayo de 2024.
Olanzapina LAI se está desarrollando como inyección subcutánea mensual para el tratamiento antipsicótico atípico. Tiene el potencial de ser la primera Olanzapina de liberación prolongada con un perfil de seguridad favorable, ya que otras LAI de Olanzapina tienen advertencias de caja negra de la FDA por PDSS. El socio de Teva, Medincell, podría recibir hasta 117 millones de dólares en hitos y regalías sobre las ventas netas.
Teva 제약이 연구 중인 올란자핀 장기 지속형 주사제 (LAI)의 주요 3상 임상 시험에 대한 업데이트를 제공했습니다. 회사는 제출을 위한 목표 주사의 약 99%가 완료되었으며, 주사 후 섬망/진정 증후군 (PDSS)이 관찰되지 않았다고 발표했습니다. Teva는 3상 안전성 결과가 2024년 하반기에 예상된다고 확인했으며, 이는 2024년 5월에 발표된 긍정적인 효능 결과에 이어진 것입니다.
올란자핀 LAI는 비정형 항정신병 치료를 위한 월 1회 피하 주사로 개발되고 있습니다. 이는 다른 LAI 올란자핀에 대해 FDA의 블랙 박스 경고가 있는 PDSS에 비해 유리한 안전성 프로파일을 갖는 첫 번째 장기 지속형 올란자핀이 될 가능성을 가지고 있습니다. Teva의 파트너인 Medincell은 마일스톤과 순매출에 대한 로열티로 최대 1억 1700만 달러를 받을 수 있습니다.
Teva Pharmaceuticals a fourni une mise à jour sur l'essai clinique pivote de phase 3 de son Olanzapine injectable à action prolongée (LAI) en cours d'investigation. La société a annoncé qu'environ 99% des injections ciblées pour soumission avaient été réalisées, sans qu'aucun Syndrome de délire/sédation post-injection (PDSS) n'ait été observé. Teva a confirmé que les résultats complets de sécurité de phase 3 sont attendus pour le second semestre 2024, à la suite des résultats d'efficacité positifs annoncés en mai 2024.
L'Olanzapine LAI est en cours de développement comme injection sous-cutanée mensuelle pour le traitement des antipsychotiques atypiques. Elle a le potentiel d'être la première Olanzapine à action prolongée avec un profil de sécurité favorable, car d'autres LAIs d'Olanzapine comportent des avertissements de la FDA concernant le PDSS. Le partenaire de Teva, Medincell, pourrait recevoir jusqu'à 117 millions de dollars en jalons et redevances sur les ventes nettes.
Teva Pharmaceuticals hat ein Update zu der entscheidenden Phase-3-Studie ihres experimentellen Olanzapin Langzeit-Injectable (LAI) gegeben. Das Unternehmen gab bekannt, dass etwa 99% der geplanten Injektionen für die Einreichung abgeschlossen sind und keine postinjektive Delirium/Sedierungssyndrom (PDSS) beobachtet wurde. Teva bestätigte, dass die vollständigen Phase-3-Sicherheits Ergebnisse für die zweite Hälfte 2024 erwartet werden, nach den positiven Wirksamkeitsergebnissen, die im Mai 2024 bekannt gegeben wurden.
Olanzapin LAI wird als einmal monatliche subkutane Injektion zur Behandlung von atypischen Antipsychotika entwickelt. Es hat das Potenzial, das erste Langzeit-olanzapin mit einem günstigen Sicherheitsprofil zu sein, da andere LAIs von Olanzapin FDA-Warnhinweise bezüglich PDSS haben. Tevas Partner, Medincell, könnte bis zu 117 Millionen Dollar an Meilensteinen und Lizenzgebühren auf Nettoumsätze erhalten.
- 99% of targeted injections for submission completed without PDSS observed
- Positive Phase 3 efficacy results announced in May 2024
- Potential to be the first long-acting Olanzapine with a favorable safety profile
- Full Phase 3 safety results expected in H2 2024
- None.
The update on Teva's phase 3 trial for Olanzapine LAI is highly significant for MedinCell and the broader psychiatric treatment landscape. The absence of Post-injection Delirium/Sedation Syndrome (PDSS) in
The anticipated H2 2024 release of full safety results, coupled with the previously announced positive efficacy data, positions this drug for a strong regulatory submission. If approved, it could become the first long-acting Olanzapine without a FDA black box warning for PDSS, potentially capturing a significant market share in the antipsychotic space.
This update significantly bolsters MedinCell's financial prospects. The completion of
Importantly, the positive safety profile could lead to broader market adoption if approved, potentially driving higher sales and royalties. Investors should note that while this news is promising, regulatory approval is still pending and commercialization challenges may lie ahead. Nevertheless, the unique positioning of this product in the lucrative antipsychotic market presents a compelling long-term growth opportunity for MedinCell.
The development of a potentially safer long-acting Olanzapine formulation addresses a significant unmet need in the antipsychotic market. The global antipsychotic drugs market, valued at
If approved, Teva and MedinCell's Olanzapine LAI could disrupt the market, potentially capturing share from both oral Olanzapine and existing long-acting injectables. The improved safety profile could drive adoption among psychiatrists who have been hesitant to prescribe current Olanzapine LAIs due to PDSS concerns. This product could become a game-changer in the treatment paradigm for schizophrenia, benefiting both companies significantly.
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No PDSS* observed after completion of c.
99% of the targeted injections for submission - Confirmation that full phase 3 safety results are on track for H2 2024
- Positive phase 3 efficacy results have already been announced in May 2024 (read the full PR)
MONTPELLIER,
Medincell (Paris:MEDCL):
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.
Teva is fully responsible for leading the development and commercialization of Olanzapine LAI. 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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Source: Medincell
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