"These data point to a very clear and compelling therapeutic profile and regulatory strategy as BDSI makes plans to prepare for a confirmatory Phase 2b study in the latter part of this year which would potentially lead to data availability before the end of 2014," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. "If this study meets its endpoint, BDSI plans to proceed with the Phase 3 placebo-controlled study in the same population."Additional financial terms of the licensing agreement include a milestone payment to Arcion of $2.5 million in unregistered shares of BDSI stock upon acceptance by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for topical clonidine gel and a cash payment to Arcion of between $17.5 and $35 million upon NDA approval, depending on certain regulatory and commercial considerations. In addition, the licensing agreement includes sales milestones and low single-digit royalties on net worldwide sales.
BioDelivery Sciences Expands Product Pipeline With Acquisition Of Patented Topical Clonidine Gel For The Treatment Of Painful Diabetic Neuropathy
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