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，梯瓦製藥工業有限公司（紐約證券交易所代碼：TEVA）和Medincell公佈了與安慰劑相比，TEV-'749對成年精神分裂症患者的三期SOLARIS試驗的療效部分的結果。
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.
結果表明，TEV-'749達到了其主要終點，衡量標準是與安慰劑相比，八週後PANSS總分與基線相比發生了變化。PANSS 衡量精神分裂症的症狀嚴重程度。
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採用了SteadyTeq，這是Medincell專有的共聚物技術，可控穩定地釋放奧氮平，奧氮平是美國處方最多的第二代精神分裂症抗精神病藥物。
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在所有三個給藥組中均達到了主要終點，高、中和低劑量組與安慰劑相比，從基線到第8周的陽性和陰性綜合徵量表（PANSS）總分變化平均差異分別爲-9.71分、-11.27分和-9.71分。
These differences from placebo were clinically meaningful and statistically significant.
這些與安慰劑的差異具有臨床意義和統計學意義。
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.
調整多重性後，CGI-S（臨床全球印象——精神分裂症）和PSP（個人和社會績效量表）總分的關鍵次要終點也具有統計學意義。
No cases of PDSS have been reported after the administration of approximately 80% of the target injection number.
在給藥約80％的目標註射量後，未報告任何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開放標籤研究（第2期）也在評估TEV-'749的長期安全性和注射後精神錯亂/鎮靜綜合徵（PDSS）的發病率，預計將在2024年下半年公佈安全數據。
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.
梯瓦製藥週三還報告稱，第一季度調整後每股收益爲0.48美元，高於去年同期的0.40美元，未達到預期的0.51美元。
The company reported sales of $3.82 billion, beating the consensus of $3.73 billion.
該公司報告的銷售額爲38.2億美元，超過了市場預期的37.3億美元。
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.
按美元計算，收入增長了4％，按當地貨幣計算增長了5％，這主要是由於歐洲和國際市場領域的Austedo和Ajovy在所有細分市場的仿製產品收入增加，但Copaxone收入的減少部分抵消了這一增長。
Generic products revenues were $808 million, up 8%, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid).
仿製藥收入爲8.08億美元，增長8％，這主要歸因於來那度胺膠囊（Revlimid的仿製版本）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，處方總量約爲3.14億張，佔美國仿製藥處方的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).
梯瓦還重申了其2024年的業務前景，收入爲157億美元至163億美元（共識爲158.62億美元），調整後的每股收益爲2.20美元至2.50美元（共識爲2.41美元）。
Price Action: TEVA shares are up 15.3% at $16.09 at last check Wednesday.
價格走勢：在週三的最後一次檢查中，TEVA股價上漲15.3％，至16.09美元。
Photo by Ralf Liebhold via Shutterstock
照片由 Ralf Liebhold 通過 Shutterstock 拍攝