Grünenthal Headquarters

German pharmaceutical firm Grunenthal and US-based AcelRx Pharmaceuticals have entered into a partnership for Zalviso, a patient-controlled analgesia drug-device combination product, for self-administration of sufentanil nanotablets by patients following surgery.

The deal covers the countries of the European Union, European Economic Area (EEA) and Australia for Zalviso (previously known as ARX-01) for use in pain treatment within or dispensed by a hospital, hospice, nursing home or other medically supervised setting.

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As part of the deal, AcelRx will supply Zalviso to Grünenthal for marketing in these countries but will retain all rights in remaining countries, including the US and Asia.

Zalviso is AcelRx’s lead programme and uses an opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation. It is delivered through a pre-programmed, non-invasive proprietary delivery device.

AcelRx will get upfront cash payment of $30m and is also eligible to get around $220m in additional milestone payments, based on successful regulatory and product development efforts and net sales target achievements.

While 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.

"Under the deal, Grunenthal will also oversee all commercial activities for Zalviso."

AcelRx president and CEO Richard King said: "Grunenthal’s commercial track record across Europe demonstrates their ability to achieve commercial success in this large market, and will, following regulatory approval, enable patients in Europe suffering with moderate-to-severe pain in a medically supervised setting to receive the benefits of our innovative, patient-centric product Zalviso."

Under the deal, Grunenthal will also oversee all commercial activities for Zalviso, which includes obtaining and maintaining pharmaceutical product regulatory approval, while will be responsible for maintaining device regulatory approval and manufacturing and supply of Zalviso to Grunenthal for commercial sales and clinical trials.

Additionally, AcelRx has announced that the US Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) action date of 27 July 2014, for its New Drug Application (NDA) for Zalviso.

Grünenthal and AcelRx are also planning to file a marketing authorisation application to EMA around mid-2014 with an expected approval and market launch of Zalviso in Europe by the end of 2015.

Image: Grünenthal Group Corporate Centre, headquarters (Aachen). Photo: courtesy of Grünenthal.