AcelRx Pharmaceuticals and Grunenthal entered into a commercial collaboration for Zalviso™ (previously known as ARX-01) for potential use in pain treatment. The deal covers territory in the European Union, other undisclosed European countries, and Australia
As part of the agreement, AcelRx will receive an upfront cash payment of $30 million. The company 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 its territory.
According to AcelRx, Zalviso is a drug-device combination product utilizing the opioid agonist sufentanil formulated in a sublingual tablet formulation and delivered through a preprogrammed, noninvasive delivery device. The company retains all rights in remaining countries, including the U.S. and Asia.
Grunenthal will be responsible for all commercial activities for Zalviso, which includes obtaining and maintaining pharmaceutical product regulatory approval. AcelRx will be responsible for maintaining device regulatory approval and manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.