Pacira Pharmaceuticals, Inc., an emerging specialty pharmaceutical company, announced that it has entered into agreements with Quintiles Commercial US, Inc. (Quintiles) and Integrated Commercialization Services, Inc. (ICS) to support the anticipated launch of Exparel (bupivacaine liposome extended-release injectable suspension), should it be approved by the Food and Drug Administration (FDA) later this year. Exparel is the company's lead investigational product candidate for post surgical pain management, which has been shown in phase III clinical trials to be well-tolerated and to reduce post surgical pain over an extended period of time compared with placebo.
Under the terms of the agreement with Quintiles, Quintiles will provide a US sales force exclusively dedicated to Exparel that will consist of approximately 70 people and will support sales efforts through December 31, 2012, or beyond if extended in accordance with the terms of the agreement. Under the terms of the agreement with ICS, ICS will serve as the exclusive third party logistics provider to Pacira to support the US commercialization of Exparel for the next three years. Both agreements may be terminated by Pacira at will in accordance with the terms of the two agreements.
“We have made significant progress executing our dynamic launch strategy for Exparel that leverages the growing body of positive clinical data and our supportive health outcome studies in anticipation of potential FDA approval in late October,” said David Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. “Under the terms of our agreement with Quintiles, we will have direct input into the selection of the newly developed, Pacira-specific sales force, which should allow us to create a dynamic, engaged team and leverage the expertise and functionality of the Quintiles organization. We believe these data, the valuable relationships we are building and strengthening within key clinical communities, and these new agreements will position us to aggressively launch Exparel if it is approved later this year. We remain excited about the opportunity to commercialize Exparel as we believe it can provide unique utility and health outcome benefits to physicians, patients and hospitals.”
Exparel is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anaesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Market data indicate that there is an unmet medical need for a longer-acting anaesthetic/analgesic for post surgical pain management. The most common adverse events following Exparel administration were nausea, constipation, and vomiting.