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Johnson & Johnson has agreed to take over Intra-Cellular Therapies in a deal worth up to $14.6 billion – the second biopharma M&A announcement today.
强生公司(Johnson&Johnson)已同意以高达146亿美元的价格收购细胞内疗法,这是今天第二次宣布的生物制药并购。
The $132-per-share agreement comes a few months after Intra-Cellular reported phase 3 results with its only commercial product Caplyta (lumateperone) that could dramatically expand its market. Shares in Intra-Cellular had rocketed by more than a third to more than $128 at the time of writing.
这项每股132美元的协议是在细胞内报告的第三阶段结果几个月后达成的,该结果是其唯一的商业产品Caplyta(lumateperone),可以极大地扩大其市场。。
Caplyta
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is already approved by the FDA to treat schizophrenia and bipolar depression as monotherapy and in combination with lithium or valproate but has also shown efficacy in major depressive disorder (MDD), a larger indication that RBC Capital Markets analysts think could drive sales above $3 billion a year..
已经被FDA批准将精神分裂症和双相抑郁症作为单一疗法,并与锂或丙戊酸钠联合治疗,但也显示出对重度抑郁症(MDD)的疗效,这一更大的迹象表明,RBC资本市场分析师认为,这可能会推动年销售额超过30亿美元。。
To put that in perspective, Intra-Cellular has estimated that Caplyta will have brought in $665 million to $685 million in sales in 2024.
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J&J is already a player in the market for drugs to treat resistant MDD with nasal spray antidepressant
强生已经是鼻喷雾剂抗抑郁药治疗耐药性MDD药物市场的参与者
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(esketamine), which made $780 million in the first nine months of 2024, along with seltorexant which is in phase 3 for insomnia associated with depression.
(esketamine)在2024年前9个月赚了7.8亿美元,而seltorexant正处于与抑郁症相关的失眠的第三阶段。
'This acquisition further differentiates our portfolio, serves as a strategic near- and long-term growth catalyst for J&J and offers compelling value to patients, health systems and shareholders,' commented the company's chief executive Joaquin Duato.
该公司首席执行官华金·杜阿托(JoaquinDuato)评论道:“此次收购进一步区分了我们的投资组合,为强生公司的近期和长期战略增长催化剂,并为患者、医疗系统和股东提供了令人信服的价值。”。
Intra-Cellular filed for approval of the drug as an add-on treatment for standard antidepressants in December, based on the results of two phase 3 trials (Study 501 and 502).
根据两项3期临床试验(研究501和502)的结果,12月,细胞内申请批准该药物作为标准抗抑郁药的附加治疗。
The two studies showed that a once-daily oral dose of Caplyta achieved a significant improvement in the Montgomery–Åsberg Depression Rating Scale (MADRS) at week six compared to placebo in patients who were unable to get sufficient benefit from standard therapies alone.
这两项研究表明,与安慰剂相比,每日一次口服Caplyta的蒙哥马利抑郁量表(MADRS)在第六周时取得了显着改善,这些患者无法单独从标准疗法中获得足够的益处。
The M&A agreement is the second to be revealed at this week's JPMorgan healthcare conference, which generally sees a flurry of M&A deals. J&J's announcmeent came just hours after GSK confirmed it had agreed a $1 billion deal to buy cancer biotech
该并购协议是本周摩根大通(JPMorgan)医疗保健会议上公布的第二份协议,该会议通常会出现一系列并购交易。就在强生发布公告几小时前,葛兰素史克(GSK)确认同意以10亿美元收购癌症生物技术公司(CancerBiotech)
IDRx
IDRx
and its KIT inhibitor for gastrointestinal stromal tumours (GIST).
及其用于胃肠道间质瘤(GIST)的KIT抑制剂。
If completed, the Intra-Cellular takeover would be the largest pharma-biotech merger since Pfizer acquired Seagen for $43 billion at the end of 2023.
如果完成,细胞内收购将是自2023年底辉瑞以430亿美元收购Seagen以来最大的制药-生物技术合并。
Caplyta is a first-in-class drug that acts on three neurotransmitter systems – dopamine, serotonin, and glutamate – and seems to have a faster onset of action than conventional antidepressant drugs, which can take weeks to have a mood-elevating effect.
Caplyta是一种一流的药物,作用于多巴胺、血清素和谷氨酸三种神经递质系统,似乎比传统的抗抑郁药起效更快,而传统的抗抑郁药可能需要数周才能产生提神作用。
It is a rival to AbbVie's
它是AbbVie的对手
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(cariprazine), which also started out as a treatment for schizophrenia and bipolar disorder and added adjunctive therapy of MDD to its label in 2022 and brought in $2.3 billion in the first nine months of 2024, as well as Axsome's Auvelity (dextromethorphan/bupropion) which made just under $200 million in the same period..
(cariprazine)也开始用于治疗精神分裂症和双相情感障碍,并于2022年将MDD的辅助治疗添加到其标签中,并在2024年前9个月带来23亿美元的收入,以及Axsome的Auvelity(右美沙芬/安非他酮),同期收入不到2亿美元。。
The acquisition also includes ITI-1284, a deuterated form of lumateperone being studied in phase 2 as a treatment for generalised anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as other clinical-stage candidates.
此次收购还包括ITI-1284,这是一种氘代形式的lumateperone,正在第二阶段进行研究,用于治疗广泛性焦虑症(GAD)和阿尔茨海默病相关的精神病和躁动,以及其他临床阶段的候选者。
News of the agreement with J&J also comes shortly after Intra-Cellular settled a patent litigation dispute with Sandoz over Caplyta. The settlement gives Sandoz rights to generic versions of Caplyta in the US, but only after 1st July 2040 (or earlier in certain circumstances). Other patent litigation remains pending in the US..
在Intra Cellular与Sandoz就Caplyta的专利诉讼纠纷达成和解后不久,也传出了与强生达成协议的消息。该协议赋予Sandoz在美国使用通用版本Caplyta的权利,但仅限于2040年7月1日之后(或某些情况下更早)。其他专利诉讼仍在美国悬而未决。。