Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), today announced results from the efficacy portion of the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia compared to placebo.

Teva Pharmaceuticals，Teva Pharmaceuticals Industries Ltd.（NYSE和TASE:Teva）的美国附属公司和Medincell（Euronext:MEDCL）今天宣布了第三阶段皮下奥氮平缓释注射研究（SOLARIS）试验的疗效部分的结果，该试验评估了与安慰剂相比成年精神分裂症患者的TEV-749。

Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo. TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine, the most prescribed 2nd generation antipsychotic for schizophrenia in the U.S.1.

结果表明，与安慰剂相比，TEV-749达到了其主要终点，这是通过8周后PANSS总分相对于基线的变化来衡量的。TEV-'749利用SteadyTeq™这一Medincell专有的共聚物技术，提供奥氮平的受控稳定释放，奥氮平是美国治疗精神分裂症处方最多的第二代抗精神病药物1。

TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points versus placebo for the high, medium, and low dose groups, respectively.

TEV-749在所有三个剂量组中均达到其主要终点，阳性和阴性综合征量表（PANSS）总分从基线到第8周的平均变化差异分别为-9.71分，-11.27分和-9.71分，高，中，低剂量组分别为安慰剂。

These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of <0.001 for each comparison. Key secondary endpoints of CGI-S (Clinical Global Impressions – schizophrenia) and PSP (Personal and Social Performance Scale) total score were also statistically significant after adjusting for multiplicity.

这些与安慰剂的差异具有临床意义和统计学意义，每次比较的调整P值均小于0.001。调整多重性后，CGI-S（临床总体印象-精神分裂症）和PSP（个人和社会表现量表）总分的关键次要终点也具有统计学意义。

No cases of PDSS have been reported to date, after administration of approximately 80% of the target injection number..

迄今为止，在给予大约80%的目标注射次数后，尚未报告PDS病例。。

An estimated 3.5 million people are currently diagnosed with schizophrenia in the U.S. It is a chronic, progressive, and severely debilitating mental disorder that affects how one thinks, feels and behaves. Currently, there is no long-acting olanzapine treatment option available for schizophrenia that does not risk post-injection delirium/sedation syndrome (PDSS).

据估计，目前美国有350万人被诊断患有精神分裂症。这是一种慢性，进行性和严重衰弱的精神障碍，会影响人们的思维，感觉和行为。目前，没有长效奥氮平治疗方案可用于不存在注射后谵妄/镇静综合征（PDSS）风险的精神分裂症。

PDSS is characterized by the sudden and unexpected onset of delirium or sedation within the first several hours of receiving treatment and has been associated with the intramuscular injection of long-acting olanzapine..

PDSS的特征是在接受治疗的最初几个小时内突然出现意外的deli妄或镇静，并且与肌肉注射长效奥氮平有关。。

“These encouraging results from the efficacy portion of our Phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.

Teva全球研发执行副总裁兼首席医疗官埃里克·休斯（EricHughes）博士说：“我们的第三阶段SOLARIS试验的疗效部分的这些令人鼓舞的结果表明，TEV-749有望成为精神分裂症的有效长效治疗选择，并进一步表明我们致力于推进心理健康等领域的创新科学。”。

“Schizophrenia can be a devastating disease for both the people struggling with it as well their families. Schizophrenia is often a chronic life-long disease, but by using medication consistently, people can find the treatment help they deserve. This also has the potential to reduce the burden for not only themselves, but their caregivers and loved ones as well.”.

“精神分裂症对与之斗争的人以及他们的家人来说都可能是一种毁灭性的疾病。精神分裂症通常是一种慢性终身疾病，但通过持续使用药物，人们可以找到他们应得的治疗帮助。这也有可能不仅减轻他们自己的负担，而且减轻他们的照顾者和亲人的负担。”。