BioDelivery Sciences International, Inc. (BDSI) announced it has entered into a worldwide licensing agreement with Arcion Therapeutics. Under the agreement, BioDelivery Sciences will develop and commercialize topical clonidine gel for the treatment of painful diabetic neuropathy and potentially other indications.
BioDelivery Sciences will make an upfront payment of $2 million to Arcion in the form of unregistered shares of common stock. Additional financial terms include a milestone payment to Arcion of $2.5 million in unregistered shares of BioDelivery stock upon acceptance by the FDA of a 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. The agreement also includes sales milestones and low single-digit royalties on net worldwide sales.
BioDelivery Sciences estimates annual peak sales potential for topical clonidine gel in excess of $300 million.
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