Grunenthal seeks EMA approval for Zalviso

7 July 2014 (Last Updated July 7th, 2014 18:30)

Grunenthal Group has submitted a marketing authorisation application (MAA) to the European Medicines Authority (EMA) for Zalviso to manage moderate to severe acute pain in adult patients in a medically supervised environment.

Grunenthal Group has submitted a marketing authorisation application (MAA) to the European Medicines Authority (EMA) for Zalviso to manage moderate to severe acute pain in adult patients in a medically supervised environment.

Zalviso is a drug-device combination product that uses the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device.

In December 2013, Grunenthal and AcelRx entered into licence and supply agreements for Zalviso in the EU, Australia and certain other countries.

"Under the deal, Grunenthal will be responsible for all commercial activities for Zalviso."

As part of the agreement, AcelRx will receive a cash payment of $5m for the MAA submission and is also eligible to receive an additional $15m milestone payment upon approval of the marketing application.

Upon securing EMA approval, AcelRx is eligible to receive approximately $200m in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements.

Under the deal, 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, as well as manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.

The deal will see Grunenthal make tiered royalty, supply and trademark fee payments in the mid-teens up to 20% range, on net sales of Zalviso in the Grunenthal territory.

AcelRx Pharmaceuticals president and CEO Richard King said: "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."