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News Breaks
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 24, 2015
08:34 EDTACRXAcelRx's Zalviso recommended for marketing authorization by Europe's CHMP
AcelRx Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, has adopted a positive opinion for Zalviso. The opinion, while not binding, recommends marketing authorization for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. Zalviso is an investigational drug-device combination product designed to deliver a sublingual formulation of sufentanil 15 mcg via a proprietary pre-programmed, non-invasive, patient-controlled device. The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union. If approved, Grunenthal expects to launch Zalviso beginning in 1H16. In addition, AcelRx would be eligible to receive a $15M milestone payment from AcelRx's licensee in Europe, Grunenthal, upon approval. AcelRx had previously received CE Mark approval of the Zalviso device and ISO certification of its quality management system issued by the British Standards Institution.

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