Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today provided updated timing for its commercial launch of EXPAREL® (bupivacaine liposome injectable suspension), a non-opioid analgesic that was approved by the U.S. Food and Drug Administration (FDA) for administration into the surgical site to produce postsurgical analgesia.
Since FDA approval of EXPAREL in October 2011, Pacira has continued to execute its pre-commercial launch strategy focused on the broad hospital market and has undertaken initiatives to expand and enhance its ability to efficiently manufacture commercial quantities of EXPAREL.
As planned, Pacira has hired and trained a sales force and will proceed with a formulary-access driven launch strategy, beginning with a national sales meeting this week. Due to commercial manufacturing challenges, which Pacira is confident it can address, the company projects product availability in April 2012, by which time Pacira expects it will have manufactured sufficient product to meet customer demands at launch.
"Our goal is to ensure that we have an appropriate commercial supply of EXPAREL to support anticipated demand for the product following our launch," said Dave Stack, president and chief executive officer of Pacira. "We are encouraged by the positive response we have received following FDA approval of EXPAREL and our organization is focused on our commercial manufacturing processes. With the recent appointment of John Pratt to the newly created role of general manager for our San Diego manufacturing facility, we believe we have added leadership who will directly contribute to our ability to meet our goals. John has more than 35 years of experience in building and leading state-of-the art pharmaceutical manufacturing and quality control organizations including senior positions at Amylin and Novo Nordisk, and his expertise will be valuable as we execute our manufacturing strategy. We are very excited about EXPAREL and the role it can play in optimizing postsurgical pain management and look forward to bringing this product to the market."
Taunia Markvicka, vice president, commercial at Pacira, added, "During the first quarter our sales force will work closely with our commercial and scientific affairs teams to achieve formulary approvals at our target hospitals. In line with our announced strategy, we have introduced multiple important educational initiatives, including preceptorship programs, and continued to work to implement opioid sparing protocols within several key institutions. We are also initiating our Phase 4 clinical programs that will provide healthcare professionals with hands-on experiences with the product. We believe all of these activities will help drive additional demand for EXPAREL as we continue to focus our promotional programs and investments to align the deployment of our resources with near-term revenue opportunities."
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