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Zalviso

AcelRx Pharmaceuticals, Inc.

Drug Names(s): ARX-01, ARX-F01, sublingual sufentanil (drug/device), Sufentanil NanoTab PCA System

Description: ARX-01 is a sublingual formulation of the opioid pain medication, sufentanil. ARX-01 is based on the AcelRx's proprietary NanoTab dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route.

The ARX-01 Oral Patient-Controlled Analgesia (PCA) system is based on a proprietary pre-programmed, hand-held dispenser being developed by AcelRx. The AcelRx dispenser is designed to be hospital compliant for administration of Sublingual Sufentanil NanoTabs, while providing features directed to patient safety and convenience.

Deal Structure: AcelRx Pharmaceuticals and Grunenthal GmbH
On December 2013, AcelRx Pharmaceuticals and Grunenthal GmbH announced that they have entered into a commercial collaboration, covering the territory of the European Union, certain other European countries and Australia for ZALVISO (previously known as ARX-01) for potential use in pain treatment within or dispensed by a hospital, hospice, nursing home or other medically supervised setting. AcelRx retains all rights in remaining countries, including the U.S. and Asia.

Under the terms of the agreement, AcelRx will receive an upfront cash payment of $30 million. AcelRx is eligible to receive approximately $220 million in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements. Grunenthal will also make tiered royalty, supply and trademark fee payments in the mid-teens up to the mid-twenties percent range, on net sales of ZALVISO in the Grunenthal...See full deal structure in Biomedtracker

Partners: Grünenthal GmbH PDL BioPharma, Inc.


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