UCB buys epilepsy firm Engage Tx in $270m deal
Deal includes experimental drug-device combination therapy Staccato Alprazolam
Belgium drugmaker UCB has bolstered its epilepsy franchise with the acquisition of US biotech Engage Therapeutics and its experimental drug-device combination therapy Staccato Alprazolam.
UCB says the therapy could become the first “on-demand, single-use treatment to rapidly terminate an active epileptic seizure” and could be of use in 20-30% of all epilepsy patients.
Staccato Alprazolam – currently in mid-stage clinical testing – works a little bit like an EpiPen for a severe allergic reaction. However, rather than being delivered as a self-injection, the drug takes the form of a handheld inhaler that delivers a raid dose of alprazolam, a well-established rescue therapy for epileptic seizures, with a single normal breath.
UCB is paying $125m upfront for Engage, claiming worldwide rights to Staccato Alprazolam which was originally developed by California’s Alexza Pharma, acquired by Spain’s Ferrer in 2016.
The Belgian company is also on the hook for milestone payments tied to development and commercial achievements that could total $145m.
Earlier this year, Engage reported the results of its phase 2b StATES trial, which found that 66% of people treated with the drug as rescue therapy for an active seizure resolved symptoms within two minutes, with no recurrence within two hours.
Just 43% of a match placebo group achieved that outcome, and the difference between the two groups was statistically significant, according to the data, which was presented at virtual American Academy of Neurology congress in April.
The Staccato inhaler is already on the US and European markets as an integral part of Alexza’s Adasuve (loxapine) product, used for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
If approved for marketing, Staccato Alprazolam would slot into UCB’s epilepsy franchise alongside drug treatments like Keppra (levetiracetam), Vimpat (lacosamide) and Briviact (brivaracetam). The company also sells a nasal spray formulation of midazolam – called Nayzilam – in the US market.
UCB is however facing patent expiries for Vimpat in 2024, threatening a drug that contributed €1.3bn out of the company’s total sales of €4.9bn last year, and it needs new products to bolster the franchise before the onset of generic competition to the brand.
It’s also due to lose patent protection for immunology blockbuster Cimzia (certolizumab pegol) around the same time, threatening a drug which contributed €1.7bn in 2019.
比利时制药商 UCB 公司通过收购美国生物技术公司 Engage Therapeutics 及其试验性药物-设备组合疗法 Staccato Alprazolam 巩固了其癫痫专营权。UCB 表示，该疗法可能成为首个“按需、一次性使用的快速终止活动性癫痫发作的治疗方法”，并可能在 20-30% 的癫痫患者中使用。阿普唑仑-目前正处于中期临床试验阶段-其作用有点像重度过敏反应的 EpiPen。然而，这种药物并不是以自我注射的形式递送，而是以手持式吸入器的形式递送一剂 raid 剂量的阿普唑仑，这是一种公认的癫痫发作急救疗法，只有一次正常呼吸。UCB 为 Engage 支付了 1.25 亿美元的预付款，并声称对 Staccato 阿普唑仑拥有全球权利。Staccato 阿普唑仑最初由加州的 Alexza Pharma 开发，于 2016 年被西班牙的 Ferrer 收购。这家比利时公司还将获得与开发和商业成就相关的里程碑付款，总额可能达到 1.45 亿美元。今年早些时候，Engage 报道了其 iib 期 StATES 试验的结果，该试验发现 66% 的人接受该药作为活动性癫痫发作的补救治疗，在 2 分钟内症状缓解，2 小时内无复发。根据 4 月份在 virtual American Academy of Neurology congress 上发布的数据，匹配的安慰剂组仅有 43% 的人达到了这个结果，两组之间的差异具有统计学意义。Staccato 吸入器已作为 Alexza 的 Adasuve（洛沙平）产品的组成部分在美国和欧洲上市，用于急性治疗成人精神分裂症或双相 i 型障碍相关的激越。如果批准上市，阿普唑仑将与 Keppra（左乙拉西坦）、Vimpat（拉科酰胺）和 Briviact（布瓦西坦）等药物一起进入 UCB 的癫痫专营权。该公司还在美国市场销售一种名为 Nayzilam 的咪达唑仑鼻喷雾剂。然而，UCB 正面临 2024 年 Vimpat 专利到期的威胁，该药物在该公司去年 49 亿欧元的总销售额中贡献了 13 亿欧元，在该品牌仿制药竞争开始之前，UCB 需要新产品来支撑特许经营权。同时，Cimzia (certolizumab pegol) 失去了免疫学重磅炸弹的专利保护，这也威胁到 2019 年贡献了 17 亿欧元的药物。
扫码实时看更多精彩文章
