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MedinCell的合作伙伴Teva宣布mdc-TJK/Olanzapine长效注射剂(LAI)的3期临床研究招募完成

MedinCell’s partner Teva Announces Recruitment Completion of Phase 3 Clinical Study of mdc-TJK / Olanzapine Long-Acting Injectable (LAI)

businesswire 等信源发布 2024-01-10 01:26

可切换为仅中文


MONTPELLIER, France--(BUSINESS WIRE)--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.

法国蒙彼利埃--(商业新闻短讯)--Teva Pharmaceutical Industries Ltd.在摩根大通医疗保健会议上宣布,预计640名mdc TJK(TEV-44749)正在进行的3期临床试验参与者将成功完成在欧盟和美国的注册。研究结果预计将于2024.1年下半年公布。

mdc-TJK is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. It has the potential to be the first long-acting olanzapine with a favorable safety profile.2

mdc TJK是一种每月一次的研究性皮下长效注射非典型抗精神病药物奥氮平,用于治疗精神分裂症。它有可能成为第一种具有良好安全性的长效奥氮平。2

Teva remains fully responsible to lead the development and commercialization of olanzapine LAI globally.

梯瓦仍然完全负责领导奥氮平LAI在全球的开发和商业化。

MedinCell may receive up to $117 million in development and commercial milestones over the coming years for mdc-TJK, and is eligible for royalties on all net sales.

MedinCell在mdc TJK未来几年可能会获得高达1.17亿美元的开发和商业里程碑,并且有资格获得所有净销售额的版税。

1 Full webcast of Teva’s presentation at 42nd Annual J.P. Morgan Healthcare Conference, January 8, 2024 is available on ir.tevapharm.com.

2024年1月8日,第42届摩根大通医疗保健年会上,特瓦的演讲在ir.tevapharm.com上进行了完整的网络直播。

2 The only existing LAI of Olanzapine has a FDA black box warning from for PDSS (Post injection Delirium/Sedation Syndrome) that limits its use.

2奥氮平唯一存在的LAI具有FDA针对PDSS(注射后谵妄/镇静综合征)的黑匣子警告,限制了其使用。

About MedinCell

关于MedinCell

MedinCell is a clinical- and commercial-stage biopharmaceutical 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.

MedinCell是一家临床和商业阶段的生物制药公司,在许多治疗领域开发长效注射药物。我们的创新治疗方法旨在确保遵守医疗处方,提高药物的有效性和可及性,并减少其环境足迹。

They combine already known and used active 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 the United States by Teva under the name UZEDY™ (BEPO technology is licensed to Teva under the name SteadyTeq™)..

他们将已知和使用的活性成分与我们专有的BEPO®技术相结合,该技术通过皮下或局部注射几毫米的简单沉积物,完全可生物吸收,控制药物在治疗水平上的输送数天,数周或数月。2023年4月,FDA批准了第一种基于BEPO技术的治疗精神分裂症的药物,目前由Teva以UZEDY的名义在美国销售™ (BEPO technology以SteadyTeq的名义授权给Teva™)..

We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, MedinCell currently employs more than 140 people representing more than 25 different nationalities.

我们与领先的制药公司和基金会合作,通过新的治疗方案改善全球健康。总部位于蒙彼利埃的MedinCell目前拥有140多名员工,他们来自25个不同的国家。

UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals

结论™ 和SteadyTeq™ 是Teva Pharmaceuticals的商标

www.medincell.com

www.medicell.com