Grunenthal Submits Marketing Authorization Application For ZALVISO To EMA

(RTTNews) - AcelRx Pharmaceuticals, Inc. (ACRX) and Grunenthal Group announced that Grunenthal has submitted a Marketing Authorization Application (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. The regulatory review is expected to take twelve to sixteen months.

AcelRx will receive a cash payment of $5 million for the MAA submission. The company is also eligible to receive an additional $15 million milestone payment upon the approval of the MAA. After approval by EMA, AcelRx is eligible to receive approximately $200 million in additional milestone payments. 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 ZALVISOTM in the Grunenthal territory.

ZALVISOTM 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 ZALVISOTM in the EU, Australia and certain other countries in December 2013.