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Source: Pacira Pharmaceuticals, Inc.

Pacira Pharmaceuticals and GeneAlign Announce Partnership to Develop Low-Opioid Pain Management Protocols for Postsurgical Patients at High Risk of Addiction

Collaboration will leverage genetic testing to identify patients predisposed to developing addiction following opioid exposure

PARSIPPANY, N.J., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced a joint endeavor with GeneAlign, a therapeutic management and solutions company working to revolutionize personalized medicine through a patient-specific opioid risk assessment program that includes behavioral surveys, educational tools and genetic testing. Under the collaborative research partnership, a GeneAlign scientific team will work alongside a Pacira team to develop and utilize these survey tools and genetic testing assets to identify preoperative patients with genetic markers indicating a potential predisposal to opioid addiction.

This hospital-based initiative is currently being rolled out in pilot institutions and includes a GeneAlign genetic test conducted via a quick and painless cheek swab that collects information on 19 genes associated with metabolism, clinical response and addiction risk. The test provides important information regarding the patient’s genetic predisposition to numerous commonly prescribed opioids and other non-opioid drugs relevant to the perioperative setting. Additionally, this comprehensive program provides patients with education about the risks and benefits associated with opioid and non-opioid pain medications, including the potential for opioid addiction. The patient’s attending clinicians will then have access to this information to assist them in the development of individualized postsurgical pain management strategies following evidence-based protocols.

“As personalized medicine becomes increasingly integrated into clinical practice, providers need access to actionable genetic data at the point of care to better understand which drugs to utilize, which drugs to avoid and what opioid or non-opioid alternatives may be best suited for each individual patient,” said Jim Silliman, MD, an orthopedic surgeon and president and chief executive officer of GeneAlign. “We are proud to collaborate with Pacira on this important initiative to help advance clinicians’ therapeutic decision-making processes and, ultimately, to optimize patient outcomes and reduce the overall opioid burden.”

Beyond the unwanted and potentially life-threatening adverse events associated with opioid use, research continues to uncover the connection between their introduction in the hospital setting and the overall societal opioid burden.

“As the opioid epidemic continues to ravage our nation, we are privileged to partner with GeneAlign on an actionable solution to help curb the proliferation of opioid misuse, abuse and addiction that often begins through exposure to these medications in the postsurgical setting,” said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. “This joint undertaking to revolutionize the concept of personalized medicine for our hospital patients truly embodies the Pacira corporate commitment to improve patient care.”

A recent article in the Journal of the American Medical Association highlighted that for opioid-naive patients, many surgical procedures are associated with an increased risk of chronic opioid use in the postsurgical period;1 perhaps more startling, a recent national survey revealed that one in 10 patients admit they’ve become addicted to or dependent on opioids after being exposed to these powerful medications following an operation.2

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 flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

About GeneAlign

GeneAlign is a therapeutic management company that integrates advanced molecular diagnostics and toxicology testing with expert-guided therapeutic recommendations from licensed medical professionals to provide precision medicine solutions for perioperative medicine.  GeneAlign’s pharmacogenetic technologists provide clinically relevant genetic lab testing services on 19 genes associated with the metabolism, response and drug interactions for hundreds of the most commonly-prescribed medications including opioids, NSAIDS and opioid antagonists. GeneAlign’s Medical Directors and PharmDs collaborate with the treating providers to provide the most appropriate and safe perioperative pain management. Substance abuse experts assist in the immediate post-operative period as part of the integrated team.

Forward Looking Statements

 Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” 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 use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; 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; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; 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, 2015 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. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such 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.

  1. Sun EC, Darnall B, Baker LC, Mackey S. JAMA Intern Med. Published online July 11, 2016. doi:10.1001/jamainternmed.2016.3298.
  2. Wakefield Research on behalf of Pacira Pharmaceuticals. Opioid Addiction and Dependence After Surgery is Significantly Higher than Previously Known. 2016.