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Pacira Pharmaceuticals, Inc. (PCRX) Release: Two New Studies Support Use Of EXPAREL For Postsurgical Pain Management Following Total Joint Replacement



3/14/2014 1:30:16 PM

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PARSIPPANY, N.J. and NEW ORLEANS, March 14, 2014 – Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced new data evaluating the use of EXPAREL® (bupivacaine liposome injectable suspension) to manage postsurgical pain following total joint arthroplasty (TJA), which included hip and knee replacement surgery. The data, derived from two studies presented at the 81st annual meeting of the American Academy of Orthopedic Surgeons (AAOS), demonstrated the benefits of EXPAREL in improving a variety of key post-TJA outcomes including pain management, incidence of accidental falls, opioid consumption, and hospital stay/costs. The AAOS 2014 meeting is being held in New Orleans from March 11-15, 2014.

More than 1 million patients have a hip or knee replaced each year in the United States[i], and improving the speed and quality of postsurgical recovery is of continued importance to surgeons. The current standard of pain management is a continuous femoral nerve block, a regional anesthetic technique in which a patient is tethered to a catheter and needle which delivers an anesthetic that numbs the area from the groin to the knee for 10 to 24 hours. While providing effective pain control, continuous femoral nerve blocks are often associated with muscle weakness, limited mobility and increased risk of accidental falls. As a result, surgeons are exploring new approaches to pain management centered around site-specific local analgesics such as EXPAREL, which can effectively control pain for up to three days after surgery with a single injection, while preserving joint function and allowing patients to resume activity sooner.

Today, Dr. John Barrington, orthopedic surgeon at Texas Center for Joint Replacement in Plano, TX, led a podium presentation on a prospective, case-control study comparing 1,000 joint replacements (hips and knees) using EXPAREL-based multimodal therapy to 1,000 previous cases which used standard pain management regimens (general, local and regional anesthesia pre- and perioperatively, and non-steroidal anti-inflammatory drugs, acetaminophen and oral/IV narcotics for postoperative rescue). The study showed that the cases using EXPAREL demonstrated:

- Improved overall mean pain scores (1.98 vs. 2.41; P<0.0001) using a visual analog scale (VAS), and a higher percentage of VAS scores that were 0 (48.8% vs. 40.2%; P<0.0001)

- Decreased length of hospital stay (2.66 vs. 2.83 days; P=0.0151)

- Lower incidence of accidental falls (0.2% vs. 1.0%; P=0.0207)

- Overall cost of care savings of $1,246.11 per case

- Improved Press Ganey Overall Satisfaction (98.3% vs. 96.7%; P=0.0221)

“With the launch of HCAHPS[ii] and its accompanying mandate to correlate reimbursement rates with high patient satisfaction scores, optimizing postsurgical pain management is of increasing importance to clinicians, hospitals and payers,” said Dr. Barrington. “Our data found that an EXPAREL-based regimen not only improves pain scores and patient satisfaction, but also moves the needle on length of stay and hospital costs. From my perspective, these outcomes represent a win-win for all key stakeholders in the healthcare system -- hospitals looking to keep costs down without compromising care, payers looking to minimize incremental costs associated with complications that delay discharge, and most importantly, patients who want a comfortable recovery.”

A second study, a poster presented by Dr. Roger Emerson, Jr., was a retrospective analysis of 72 knee replacements to determine whether EXPAREL provided comparable pain control and lower postsurgical opioid use compared to continuous femoral nerve block. The study showed that compared to patients treated with a continuous femoral nerve block, patients who received EXPAREL reported:

- Comparable average pain scores (1.8 for EXPAREL vs. 2.3 for nerve block, using a VAS)

- Significantly lower opioid consumption (82 mg for EXPAREL vs. 176.6 mg for nerve block, P=0.0000514)

- No incidence of quadriceps weakness (which typically results from blocking the femoral nerve)

“Continuous femoral nerve block is an essential anesthetic tool, but in its current form, it has limitations that may outweigh its benefits in some patients. Apart from its residual effects on muscle strength and range of motion, the ability to extend the duration of the nerve block to cover the postsurgical period requires the continuous use of a catheter placed into the surgical limb, which further restricts patient mobility,” said Dr. Emerson, orthopedic surgeon at Texas Center for Joint Replacement in Plano, TX. “Based on our data and clinical practice, EXPAREL as part of a multimodal pain management regimen has shown promise in circumventing the downsides of nerve blocks, without compromising superior pain control.” EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia, and is also being evaluated as a single administration anesthetic to achieve a nerve block.

About Pacira Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL® (bupivacaine liposome injectable suspension), was commercially launched in the United States in April 2012. EXPAREL and two other products have utilized the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

About EXPAREL EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. Additional information is available at www.EXPAREL.com

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.

Forward Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements about our plans and expectations regarding EXPAREL, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the indications of EXPAREL, including for nerve block and the related timing and success of an sNDA; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical studies in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2013, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts:

Company Contact:

Pacira Pharmaceuticals, Inc.

Jessica Cho, (973) 254-3574, Jessica.Cho@pacira.com

Media Contact:

Pure Communications, Inc.

Susan Heins, (864) 286-9597, sjheins@purecommunicationsinc.com

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