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Phase III Studies of EXPAREL™ (DepoBupivacaine) from Pacira Complete Enrollment
Data from Soft Tissue and Bone Surgery Studies Basis of Planned 2009 NDA Filing
Parsippany, NJ, January 6, 2009 - Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL™ (DepoBupivacaine) for prolonged postoperative analgesia. Results from the studies in hemorrhoidectomy and in total knee arthroplasty (TKA) are expected to provide the primary clinical data, in addition to extensive existing preclinical and clinical data, for a planned 2009 NDA filing under U.S. Food and Drug Administration 505 (b)(2) regulations.
EXPAREL, a proprietary product from Pacira Pharmaceuticals, is a novel long-acting, sustained-release formulation of bupivacaine, a local anesthetic widely used for treating postoperative pain. EXPAREL is being studied in several different types of surgical procedures where postoperative pain management is especially problematic and where the need for prolonged analgesia with a single intraoperative administration can provide a significant improvement in pain relief - especially during the first 72-hours following surgery - while also minimizing the need for opioids. With improved prolonged postoperative pain management and a reduction in opioid consumption, Pacira believes patients treated with EXPAREL will experience better pain management and have fewer opioid-related side effects such as nausea and vomiting, and improved outcomes overall.
Recently, Pacira reported the results of a Phase II TKA study of EXPAREL at the International College of Surgeons meeting in Vienna, Austria. The data showed the new sustained-release analgesic significantly reduced postoperative pain, opioid use, and reduced opioid-related adverse events compared to the gold standard pain medication.
Pacira is seeking a co-promotion partner for EXPAREL in the United States. Outside the United States (except Japan), EXPAREL is available for licensing in both human and animal health applications. In the United States, Pacira intends to commercialize EXPAREL and its proprietary pipeline products within specialty acute care. Partnerships in the U.S. for both human and animal health to expand the commercialization are currently in development. EXPAREL is the latest product to benefit from Pacira's proprietary sustained-release DepoFoam® technology. DepoFoam technology is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. It achieves this by encapsulating the drug in multivesicular liposomal particles which then release the drug over a desired period of time without altering the drug molecule. DepoFoam is a proven technology that is already used in two commercially available products in the U.S. and Europe.
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceutical company founded in March, 2007 through the acquisition of the former SkyePharma PLC injectable business, for which an experienced management team was assembled to address the needs of the acute care market. The company's most advanced product, EXPAREL™ (DepoBupivacaine), a bupivacaine-based product intended to deliver postoperative pain relief by infiltration, is in late Phase III clinical development. Pacira will also study EXPAREL for nerve block, non-surgical pain such as long bone fracture and for intraarticular injection. EXPAREL benefits from the proprietary DepoFoam Technology owned by Pacira. Two other DepoFoam-based products -- DepoDur® and DepoCyt/DepoCyte® -- are marketed by partners in several global territories. The DepoFoam technology also forms the basis of multiple development projects providing Pacira an opportunity to expand its pipeline. Pacira owns two cGMP production facilities which produce the two approved products, EXPAREL clinical development and all pipeline materials. Additional information about Pacira is available at www.pacira.com.
This news release and the anticipated presentation contain forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs and the preliminary results from the clinical trials. Actual results could differ materially from those projected and the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Taunia Markvicka Vice President, Commercial Development