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Grünenthal and AcelRx enter into partnership for EU commercialization of ZALVISO®
Aachen, Germany / Redwood City (California), USA (ots) - Grünenthal Group today announced that the company entered into a commercial partnership with AcelRx Pharmaceuticals, Inc. for ZALVISO, a patient-controlled analgesia device for self- administration of sufentanil nanotablets by patients following surgery. The agreement covers the countries of the European Union, EEA and Australia. AcelRx will supply Grünenthal with the product and retains all rights in remaining countries including the US and Asia. With this partnership Grünenthal, a family-owned company headquartered in Aachen, Germany, significantly strengthens its hospital franchise and underlines its strong market position as a pain specialist in the pharmaceutical market.
Strategic portfolio expansion for the benefit of more than 20 million patients
According to market research there are more than 20 million patients in Europe who could potentially benefit from this innovative alternative to current treatment options in acute post-operative pain management. Additionally, this device is an excellent expansion of Grünenthal's existing portfolio of innovative drugs for the treatment of moderate to severe chronic pain.
"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 Grünenthal 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 Pâques, Grünenthal's Chief Executive Officer.
"As an established leader in providing pain management solutions to patients throughout Europe, Grünenthal is an excellent partner for AcelRx and for ZALVISO" said Richard King, President and CEO. "Grünenthal's commercial track record across Europe demonstrates their ability to achieve commercial success in this large market, and will enable patients in Europe suffering with moderate-to- severe pain in a medically supervised setting to receive the benefits of our highly innovative, patient-centric product ZALVISO."
Market launch of ZALVISO in Europe planned for 2015 An NDA for ZALVISO was submitted to the FDA on September 27 and accepted for filing by the FDA on December 02. An approval for the US-market could be expected in the third quarter of 2014. Grünenthal and AcelRx are planning to submit a MAA to EMA around mid-2014 with an anticipated approval and go to market in Europe by the end of 2015. Under the terms of the agreement, Grünenthal pays an upfront cash payment of $30 million to AcelRx and up to $220 million in additional milestone payments, based upon successful regulatory and product development efforts and net sales target achievements as well as royalty payments on net sales of ZALVISO in the Grünenthal territory.
The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus to be a leader in therapy innovation. Grünenthal is one of the last five remaining research-oriented pharmaceutical companies with headquarters in Germany which sustainably invests in research and development. Research and development costs amounted to about 26 percent of revenues in 2012. Grünenthal's research and development strategy concentrates on selected fields of therapy and state-of-the- art technologies. We are intensely focused on discovering new ways to treat pain better and more effectively, with fewer side-effects than current therapies. Altogether, the Grünenthal Group has affiliates in 26 countries worldwide. Grünenthal products are sold in more than 155 countries. Today, approx. 4,400 employees are working for the Grünenthal Group worldwide. In 2012, Grünenthal achieved revenues of USD 1,251 mn. More information: www.grunenthal.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx's lead product candidate, ZALVISO, is designed to solve the problems associated with post-operative intravenous patient- controlled analgesia which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the complexity of infusion pumps. AcelRx has announced positive results from each of the three Phase 3 clinical trials for ZALVISO and has submitted an NDA to the FDA seeking its approval. AcelRx has also announced positive top-line results for a Phase 2 trial for ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, funded through a grant from the U.S. Army Medical Research and Materiel Command. The company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx's clinical programs, please visit www.acelrx.com.