AcelRx spikes on $250M deal for late-stage pain drug/device Zalviso

AcelRx Pharmaceuticals has a deal for its drug-device pain therapy dubbed Zalviso. The Redwood City, CA-based biotech is pocketing $30 million upfront from Germany's Grünenthal, which will also pay up to $220 million more in milestones for the treatment, nabbing European and Australian marketing rights.

The company's shares ($ACRX) shot up 16% on the news regarding Zalviso, which is under FDA review.

The FDA has set a mid-2014 PDUFA date for Zalviso, a handheld pain management system that provides post-op patients some control of their dosing of sublingual Sufentanil NanoTabs. Investigators say they collected positive data from a string of three late-stage studies for Zalviso, the biotech's lead program initially referred to as ARX-01.

Grünenthal also committed to tiered royalty, supply and trademark fee payments in the mid-teens up to the mid-twenties percent.

"We are extremely pleased to enter into this collaboration with AcelRx and its proven concept of a patient-controlled analgesia system to address a significant unmet medical need, thereby allowing hospitals to avoid the challenges of intravenous line-related infections, as well as freeing hospital personnel from the need to program intravenous infusion pump systems. With Zalviso Grunenthal is building on its presence in the hospital market, an area that provides us with significant growth opportunities in the mid- and long-term," said Prof. Eric-Paul Paques, Grünenthal's CEO.

- here's the press release

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