Grunenthal Group submits Marketing Authorization Application to EMA for ZALVISO

AcelRx Pharmaceuticals, Inc.Jul 7 2014

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) and Grunenthal Group announced today 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. ZALVISO^TM 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^TM 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 $5 million for the MAA submission. AcelRx is 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, 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^TM in the Grunenthal territory. With the partnership Grunenthal, a family-owned global pharmaceutical company headquartered in Aachen, Germany, significantly strengthens its hospital franchise and underlines its strong market position as a pain specialist in the pharmaceutical market.

"We are pleased with the timely progress and collaborative nature of our relationship with Grunenthal which has enabled the ZALVISO MAA to be submitted on schedule," said Richard King, President and CEO of AcelRx Pharmaceuticals, Inc. "We look forward to the time when the benefits of ZALVISO might be available to all medically supervised patients in moderate to severe pain in the European Union."

"This important step is a key milestone in bringing a new treatment option to patients. Through the license agreement with AcelRx Grunenthal is again emphasizing its commitment to pain patients as an independent, global pharmaceutical company with long-time experience in the development of innovative and effective pain treatments," said Prof. Dr. Eric-Paul Paques, Grunenthal's Chief Executive Officer.

Under the terms of the collaboration, Grunenthal will be responsible for all commercial activities for ZALVISO, including obtaining and maintaining pharmaceutical product regulatory approval in the Grunenthal territory. AcelRx will be responsible for maintaining device regulatory approval in the Grunenthal territory and manufacturing and supply of ZALVISO to Grunenthal for commercial sales and clinical trials.

Currently, there are 19 million surgical procedures with associated moderate-to-severe pain in the European Union on an annual basis for which the use of ZALVISO could be suitable. The regulatory review by EMA is expected to take twelve to sixteen months.