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July 7, 2014
05:17 EDTACRXAcelRx announces submission of MAA for Zalviso
AcelRx and Grunenthal Group announced that Grunenthal has submitted a Marketing Authorization Application, or MAA, to the European Medicines Authority for Zalviso for the management of moderate to severe acute pain in adult patients in a medically supervised environment. Zalviso is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device. AcelRx and Grunenthal entered into license and supply agreements for Zalviso in the EU, Australia and certain other countries in December 2013. Under the terms of the license agreement, AcelRx will receive a cash payment of $5M for the MAA submission. AcelRx is eligible to receive an additional $15M milestone payment upon the approval of the MAA. After approval by EMA, AcelRx is eligible to receive approximately $200M 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 twenty percent range, on net sales of Zalviso in the Grunenthal territory.
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July 18, 2014
09:00 EDTACRXAcelRx attractive ahead of Zalviso PDUFA, says Roth Capital
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