Navigation Links
Pacira Pharmaceuticals, Inc. Expands EXPAREL™ Commercial Team Infrastructure
Date:9/6/2011

PARSIPPANY, N.J., Sept. 6, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today 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 postsurgical pain management, which has been shown in Phase 3 clinical trials to be well-tolerated and to reduce postsurgical pain over an extended period of time compared with placebo.

Under the terms of the agreement with Quintiles, Quintiles will provide a U.S. 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 U.S. 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."

About Pacira

Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam® drug delivery technology, for use in hospitals and ambulatory surgery centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL, the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postsurgical analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.

About EXPAREL™

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 anesthetic/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 anesthetic/analgesic for postsurgical pain management. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and suggest statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from Phase 3 trial 316 suggest that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.

Safe Harbor

This press release contains forward-looking statements of Pacira Pharmaceuticals that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the company's plans to develop and commercialize EXPAREL; the Company's plans to continue to manufacture and provide support services for its commercial partners who have licensed DepoCyt(e) and DepoDur; the timing of, and the Company's ability to obtain, regulatory approval of EXPAREL; the timing of the Company's anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the Company's ability to serve those markets; the Company's plans to expand the indications of EXPAREL to include nerve block and epidural administration; and our commercialization and marketing capabilities.  Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements; including, the Company is dependent on the success of EXPAREL and cannot guarantee that it will receive regulatory approval or be successfully commercialized; the Company faces significant competition and its operating results will suffer if it fails to compete effectively; if the Company is unable to establish effective marketing and sales capabilities or enter into agreements with third parties to handle marketing and sales, the Company may be unable to generate product revenues; if EXPAREL does not achieve broad market acceptance, the revenues that Company generates from its sales will be limited; the Company may not receive regulatory approval for EXPAREL or the approval may be delayed; the Company has incurred significant losses since its inception and anticipates that it will incur continued losses for the foreseeable future; the Company will need to raise additional financing to continue as a going concern and may be unable to raise capital when needed; and those risks discussed in "Risk Factors" and elsewhere in Pacira Pharmaceuticals'  Annual Report on Form 10-K,  filed with the Securities and Exchange Commission on March 31, 2011 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent Pacira Pharmaceutical's views as of the date of this press release. The Company anticipates that subsequent events and development will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it has no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing Pacira Pharmaceutical's views as of any date subsequent to the date of this press release.

Contacts:

Company Contact:
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3570

or

Investor Contact:
Pure Communications, Inc.
Jennifer Beugelmans, 646-596-7473


'/>"/>
SOURCE Pacira Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Positive Phase II Study of Paciras EXPAREL(TM) (DepoBupivacaine) in Total Knee Arthroplasty Presented at International College of Surgeons World Congress
2. Positive Phase II Study of Paciras EXPAREL(TM) (DepoBupivacaine) in Hernia Repair Presented at the Postgraduate Assembly in Anesthesiology (PGA)
3. Phase III Studies of EXPAREL(TM) (DepoBupivacaine) from Pacira Complete Enrollment
4. Pacira Pharmaceuticals Announces FDA Acceptance of EXPAREL™ New Drug Application for Pain Management
5. Pacira Pharmaceuticals Presents New Data from EXPAREL Phase 3 Study at Orthopaedic Research Societys 57th Annual Meeting
6. Pacira Pharmaceuticals, Inc. Announces Pricing of Its Initial Public Offering
7. Pacira Pharmaceuticals Highlights Additional Safety Data on EXPAREL™ for Postsurgical Pain Relief at 2011 American Academy of Orthopaedic Surgeons Annual Meeting
8. Pacira Pharmaceuticals EXPAREL™ Data to be Featured at 2011 ASCPT 112th Annual Meeting
9. Pacira Pharmaceuticals to Present at the Barclays Capital 2011 Global Healthcare Conference
10. Pacira Pharmaceuticals Reports Fourth Quarter and 2010 Financial Results
11. Pacira Pharmaceuticals to Present at BioCentury Future Leaders in the Biotech Industry Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/27/2017)... MIAMI , Sept. 27, 2017  Commended for their ... recent notable awards. Ranked as number one in the South ... ninth time in Inc. 5000 yearly list, the national specialty ... CEO, Armando Bardisa will soon be honored by ... Set to receive his award ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... , ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s ... design of the shoulder pad. The shoulder pad provides optimal support and full ... while using cold therapy. By utilizing ice and water that is circulated from an ...
(Date:10/12/2017)... ... October 12, 2017 , ... Information about ... intend to develop to enable prevention of a major side effect of chemotherapy ... especially in pediatric patients. For cisplatin, hearing loss is FDA listed on-label as ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... for the 49th Congress of the International Society of Paediatric Oncology (SIOP) ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. ...
(Date:10/12/2017)... ... ... Health Literacy Innovations (HLI), creator of the Health Literacy ... Patient Education Network (CPEN), an independent professional organization that shares best practices in ... , As CPEN’s strategic partner, HLI will help support CPEN members by sharing ...
(Date:10/12/2017)... D.C. (PRWEB) , ... October 12, 2017 , ... ... Cal Dining at the University of California Berkeley, and other leading institutions in ... the buying power of institutions to change the way animals are raised for ...
Breaking Medicine News(10 mins):