Generics Player Teva Pharmaceutical Aces Late-Stage Schizophrenia Drug Study, Stock Shoots Higher
Generics Player Teva Pharmaceutical Aces Late-Stage Schizophrenia Drug Study, Stock Shoots Higher
Wednesday, Teva Pharmaceutical Industries Ltd (NYSE:TEVA) and Medincell announced results from the efficacy portion of the Phase 3 SOLARIS trial of TEV-'749 in adult patients with schizophrenia compared to placebo.
星期三，梯瓦制药工业有限公司（纽约证券交易所代码：TEVA）和Medincell公布了与安慰剂相比，TEV-'749对成年精神分裂症患者的三期SOLARIS试验的疗效部分的结果。
The results demonstrated that TEV-'749 met its primary endpoint as measured by a change in the PANSS total score from baseline after eight weeks compared to placebo. PANSS measures the symptom severity of schizophrenia.
结果表明，TEV-'749达到了其主要终点，衡量标准是与安慰剂相比，八周后PANSS总分与基线相比发生了变化。PANSS 衡量精神分裂症的症状严重程度。
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.
TEV-'749采用了SteadyTeq，这是Medincell专有的共聚物技术，可控稳定地释放奥氮平，奥氮平是美国处方最多的第二代精神分裂症抗精神病药物。
TEV-'749 met its primary endpoint across all three dosing groups, with a 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在所有三个给药组中均达到了主要终点，高、中和低剂量组与安慰剂相比，从基线到第8周的阳性和阴性综合征量表（PANSS）总分变化平均差异分别为-9.71分、-11.27分和-9.71分。
These differences from placebo were clinically meaningful and statistically significant.
这些与安慰剂的差异具有临床意义和统计学意义。
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.
调整多重性后，CGI-S（临床全球印象——精神分裂症）和PSP（个人和社会绩效量表）总分的关键次要终点也具有统计学意义。
No cases of PDSS have been reported after the administration of approximately 80% of the target injection number.
在给药约80％的目标注射量后，未报告任何PDSS病例。
The long-term safety of TEV-'749 and the incidence of post-injection delirium/sedation syndrome (PDSS) are also being evaluated in the SOLARIS open-label study (period 2), with safety data topline readout expected in the second half of 2024.
SOLARIS开放标签研究（第2期）也在评估TEV-'749的长期安全性和注射后精神错乱/镇静综合征（PDSS）的发病率，预计将在2024年下半年公布安全数据。
Wednesday, Teva Pharmaceutical also reported the first quarter adjusted EPS of $0.48, up from $0.40 a year ago, missing the consensus of $0.51.
梯瓦制药周三还报告称，第一季度调整后每股收益为0.48美元，高于去年同期的0.40美元，未达到预期的0.51美元。
The company reported sales of $3.82 billion, beating the consensus of $3.73 billion.
该公司报告的销售额为38.2亿美元，超过了市场预期的37.3亿美元。
Revenues increased 4% in U.S. dollars or 5% in local currency terms, mainly due to higher revenues from generic products in all segments, from Austedo and Ajovy in Europe and International Markets segments, partially offset by lower revenues from Copaxone.
按美元计算，收入增长了4％，按当地货币计算增长了5％，这主要是由于欧洲和国际市场领域的Austedo和Ajovy在所有细分市场的仿制产品收入增加，但Copaxone收入的减少部分抵消了这一增长。
Generic products revenues were $808 million, up 8%, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid).
仿制药收入为8.08亿美元，增长8％，这主要归因于来那度胺胶囊（Revlimid的仿制版本）的收入。
In the first quarter of 2024, total prescriptions were approximately 314 million, representing 8.2% of U.S. generic prescriptions.
2024年第一季度，处方总量约为3.14亿张，占美国仿制药处方的8.2％。
Teva also reaffirmed its 2024 business outlook, with revenues of $15.7 billion – $16.3 billion (consensus $15.862 billion) and adjusted EPS of $2.20 – $2.50 (consensus $2.41).
梯瓦还重申了其2024年的业务前景，收入为157亿美元至163亿美元（共识为158.62亿美元），调整后的每股收益为2.20美元至2.50美元（共识为2.41美元）。
Price Action: TEVA shares are up 15.3% at $16.09 at last check Wednesday.
价格走势：在周三的最后一次检查中，TEVA股价上涨15.3％，至16.09美元。
Photo by Ralf Liebhold via Shutterstock
照片由 Ralf Liebhold 通过 Shutterstock 拍摄