Advertisement
Results from the studies in hemorrhoidectomy and in total kneearthroplasty (TKA) are expected to provide the primary clinical data, inaddition to extensive existing preclinical and clinical data, for a planned2009 NDA filing under U.S. Food and Drug Administration 505 (b)(2)regulations.
Advertisement
(Logo: http://www.newscom.com/cgi-bin/prnh/20070618/PACIRALOGO)
EXPAREL, a proprietary product from Pacira Pharmaceuticals, is a novellong-acting, sustained-release formulation of bupivacaine, a local anestheticwidely used for treating postoperative pain. EXPAREL is being studied inseveral different types of surgical procedures where postoperative painmanagement is especially problematic and where the need for prolongedanalgesia with a single intraoperative administration can provide asignificant improvement in pain relief -- especially during the first 72-hoursfollowing surgery -- while also minimizing the need for opioids. Withimproved prolonged postoperative pain management and a reduction in opioidconsumption, Pacira believes patients treated with EXPAREL will experiencebetter pain management and have fewer opioid-related side effects such asnausea and vomiting, and improved outcomes overall.
Recently, Pacira reported the results of a Phase II TKA study of EXPARELat the International College of Surgeons meeting in Vienna, Austria. The datashowed the new sustained-release analgesic significantly reduced postoperativepain, opioid use, and reduced opioid-related adverse events compared to thegold 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 licensingin both human and animal health applications. In the United States, Paciraintends to commercialize EXPAREL and its proprietary pipeline products withinspecialty acute care. Partnerships in the U.S. for both human and animalhealth to expand the commercialization are currently in development. EXPARELis the latest product to benefit from Pacira's proprietary sustained-releaseDepoFoam(R) technology. DepoFoam technology is designed to address thelimitations of widely used medications by enhancing their dosing and/oradministration profile. It achieves this by encapsulating the drug inmultivesicular liposomal particles which then release the drug over a desiredperiod of time without altering the drug molecule. DepoFoam is a proventechnology that is already used in two commercially available products in theU.S. and Europe.
About Pacira
Pacira Pharmaceuticals, Inc. is an acute care specialty pharmaceuticalcompany founded in March, 2007 through the acquisition of the formerSkyePharma PLC injectable business, for which an experienced management teamwas assembled to address the needs of the acute care market. The company'smost advanced product, EXPAREL(TM) (DepoBupivacaine), a bupivacaine-basedproduct intended to deliver postoperative pain relief by infiltration, is inlate Phase III clinical development. Pacira also plans to study EXPAREL fornerve block, non-surgical pain such as long bone fracture and forintraarticular injection. EXPAREL benefits from the proprietary DepoFoamTechnology owned by Pacira. Two other DepoFoam-based products -- DepoDur(R)and DepoCyt/DepoCyte(R) -- are marketed by partners in several globalterritories. The DepoFoam technology also forms the basis of multipledevelopment projects providing Pacira an opportunity to expand its pipeline.Pacira owns two cGMP production facilities which produce the two approvedproducts, EXPAREL clinical development and all pipeline materials.
Additional information about Pacira is available at http://www.pacira.com.
This news release contains forward-looking statements that involve risksand uncertainties, including statements relating to initiation and progress ofthe Company's clinical trial programs and the preliminary results from theclinical trials. Actual results could differ materially from those projectedand the Company cautions readers not to place undue reliance on the forward-looking statements contained in the release and anticipated presentation.
Pacira Contact: Taunia Markvicka
Vice President, Commercial Development
973-254-3565
SOURCE Pacira Pharmaceuticals, Inc.
