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Chiesi Farmaceutici S.p.A.
Drug Names(s): clevidipine, Clevelox
Description: Clevidipine is being developed as a fast acting, intravenous antihypertensive for use in surgical, and perhaps other hospital-based, settings. The dihydropyridine calcium channel blocker (CCB) has a uniquely short duration of action, a short plasma half life, and a selective effect on blood pressure that makes it less suitable for the broad array of clinical uses enjoyed by the majority of the available CCBs. It is potentially analogous to the ultra short-acting beta blocker, esmolol (Brevibloc) in this respect. Some evidence exists that the reflex tachycardia associated with the use of certain CCBs is less prominent with clevidipine use.
Deal Structure: In March 2003, the Medicines Company acquired from AstraZeneca exclusive worldwide license rights to Cleviprex for all countries other than Japan. In May 2006, the Medicines Company amended their license agreement with AstraZeneca to provide exclusive license rights in Japan in exchange for an upfront payment. They acquired this license after having studied Cleviprex under the study and exclusive option agreement with AstraZeneca that they entered into in March 2002. In exchange for the license, the Medicines Company paid $1.0 million in 2003 upon entering into the license and agreed to pay up to an additional $5.0 million upon reaching certain regulatory milestones, including a payment of $1.5 million that they remitted in September 2007 as a result of the FDAs acceptance to file of their NDA for Cleviprex for the treatment of acute hypertension and a payment of $1.5 million as a result of Cleviprexs approval for sale by the FDA. Under the terms of the license agreement, the...See full deal structure in Biomedtracker
Partners: AstraZeneca PLC
Pink Sheet Chart: Cleviprex FDA Reviewers
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