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KalVista
一直在为其血浆激肽释放酶抑制剂寻找一家大型制药公司作为合作伙伴,而默沙东刚刚为其实现这一愿望
。默沙东支付3700万美元预付款收购KalVista的
糖尿病性黄斑水肿
项目,这是眼部积聚液体的一种疾病,它可导致视力丧失。默沙东还同意提供高达7.15亿美元的里程碑付款,另加上市后的销售分成。
与此同时,默沙东还支付900万美元收购这家生物技术公司9.9%的股份。
这笔交易的核心资产是KVD001,目前这款候选药物已完成1期研究,KalVista计划今年晚些时候启动2期概念验证性试验。不过默沙东也在密切跟踪KalVista正在开发的潜在口服血浆激肽释放酶抑制药物。
KalVista是一家在英美都有运营的公司,这次的交易对它来说是一次提升,因为通过该交易它获得了一个在糖尿病性黄斑水肿领域非常有实力的合作伙伴,并将在遗传性血管水肿领域能够为其口服血浆激肽释放酶抑制剂项目KVD818提供免费的资源,目前
KVD818
的1期临床试验将要结束。
KalVista首席执行官Crockett称:“血浆激肽释放酶抑制剂是糖尿病性黄斑水肿治疗的一种新途径,这款药物可以为众多患者提供获益,特别是一款口服治疗药物对这种病症的治疗是一次突破性进展。”目前,KalVista正准备启动KVD001的2期试验。
在遗传性血管性水肿
市场,目前有第一代的激肽释放酶抑制剂,如夏尔的注射用Kalbitor(ecallantide),该药物于2009年获批上市,另外正在研发的还有一系列新的口服候选药物。KalVista正在追赶BioCryst,后者的激肽释放酶抑制剂BCX7353正处于中期试验中,而去年早期候选药物avoralstat的结果却令人失望。
消息原文:
KalVista has been looking for a big pharma partner for its plasma kallikrein inhibitors, and just had its wish fulfilled by Merck & Co.
Merck is paying $37 million up front for an option to buy KalVista’s program in diabetic macular edema (DME), an accumulation of fluid in the eye that can cause sight loss, and has also agreed to provide up to $715 million in milestones plus royalties if it leads to a commercial product. It’s also paying $9 million for a 9.9% stake in the biotech.
The main focus of the deal is KVD001, which KalVista said has cleared a phase 1 study and is due to start phase 2 proof-of-concept testing later this year. However, Merck is also taking an option to follow-up compounds that could potentially be dosed orally.
It’s a boost for the Anglo-American biotech, which operates out Cambridge, Massachusetts, and Salisbury in the U.K., as it provides a deep-pocketed partner for the DME and will help provide free resources down the line for its oral plasma kallikrein inhibitor program in hereditary angioedema (HAE), led by KVD818 which is heading for the end of its first phase 1 trial.
“Plasma kallikrein inhibition is a novel approach to the treatment of DME that we believe may offer benefit to a significant number of patients, and an oral therapy particularly would represent a ground-breaking advance for treatment of this indication,” said KalVista CEO Andrew Crockett.
“We have always believed that development and commercialization of our DME therapies would require the resources of a large pharmaceutical company,” he added. As it stands, KalVista will fund and run the phase 2 trial of KVD001 with Merck expected to take a decision on its option thereafter.
The deal gives KalVista a partner with a strong presence in diabetes through drugs such as DPP4 inhibitors Januvia (sitagliptin) and Janumet (sitagliptin/metformin), and could add to that portfolio shortly with Pfizer-partnered SGLT2 inhibitor ertugliflozin, which was filed in the U.S. and Europe in May.
In HAE, KalVista is pushing to enter a market with first-generation kallikrein inhibitors already on the market such as Shire’s injectable Kalbitor (ecallantide) which has been on the market since 2009, and a string of newer, oral candidates coming through the pipeline. KalVista is playing catch-up with BioCryst, which has a kallikrein inhibitor called BCX7353 in mid-stage testing having reported disappointing results with earlier candidate avoralstat last year.