Credit: Shutterstock photoAcelRx Pharmaceuticals, Inc.ACRX announced that the European Commission has granted marketing authorization to Zalviso for the management of acute moderate-to-severe post-operative pain in adults.
The approval was expected as the company had received a positive opinion from the Committee for Medicinal Products for Human Use in Jul 2015. Zalviso is expected to be available in Western Europe from the first half of 2016. AcelRx will receive $15 million milestone payment from Grunenthal.
As a reminder, AcelRx has a collaboration agreement with Grünenthal GmbH for commercialization of Zalviso. Under the terms of the agreement, Grünenthal was granted the rights to commercialize Zalviso in Europe and Australia, while AcelRx retains the rights in North America, Asia, Latin America and Middle East/Africa.
According to information provided by the company, about 19 million surgical procedures are associated with acute moderate-to-severe post-operative pain in the EU on an annual basis.
We note that, AcelRx had sold a portion of the royalties on Zalviso sales in the EU, Switzerland and Australia to PDL BioPharma, Inc. PDLI . As per the terms of the agreement, PDL BioPharma provided gross proceeds of $65 million to AcelRx. In exchange, PDL BioPharma will receive 75% of the royalties AcelRx receives from Grünenthal as well as 80% of the first four commercial milestones subject to a capped amount.
Meanwhile, AcelRx continues to progress on its pipeline. Earlier this month, the company presented encouraging data from phase III study (SAP301) on ARX-04 carried out on patients with moderate-to-severe acute pain following ambulatory abdominal surgery. AcelRx expects to initiate a study on ARX-04 in patients in the emergency room setting in 2015.
AcelRx carries a Zacks Rank #2 (Buy). Other favorably ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN , each sporting a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
