Pacira Pharmaceuticals Inc (NASDAQ:PCRX) announced that it has achieved an amicable resolution with the United States in its lawsuit filed on September 8, 2015, Pacira Pharmaceuticals, Inc. et al v. United States Food & Drug Administration et al, 15-cv-07055 (SDNY Sept. 8, 2015)(LAK). The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia.
“We are pleased to announce a successful collaboration with the FDA to resolve this matter in an expeditious and meaningful way that allows us to get back to the important task at hand—reducing postsurgical opioid exposure by providing a non-opioid option like EXPAREL to as many patients as appropriate,” stated Dave Stack, chief executive officer and chairman of Pacira. “This is especially important given the burgeoning U.S. opioid epidemic, underscored by the reality that one in 15 patients will go on to long-term use after receiving an opioid in the hospital setting.”
The key features of the resolution are as follows:
- The U.S. Food and Drug Administration (FDA) confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
- The FDA approved a labeling supplement which amends the EXPAREL Package Insert (PI) to clarify and reinforce that:
- The use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site;
- The proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilized in the pivotal trials provided as examples for the purpose of providing general guidance;
- There was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study;
- The description of that duration of effect now includes a graphical representation of the mean pain intensity scores over time for the EXPAREL and placebo groups for the full 72-hour efficacy period, as well as information about median time to first opioid use and percentage of opioid-free patients in each treatment group
- EXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.
- The September 2014 Warning Letter is formally withdrawn via a “Rescission Letter” from Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER) to Dave Stack.
- At the request of Pacira, the Rescission Letter includes FDA guidance related to two key procedures:
- Infiltration into the transversus abdominis plane (TAP), which is a field block technique covered by the approved indication for EXPAREL
- Infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPAREL
- The United States acknowledges that the rescission of the Warning Letter and approval of the Labeling Supplement reflect the scope of the indication in the NDA that FDA approved on October 28, 2011.
- Pacira and FDA agree that, in future interactions, they will deal with each other in an open, forthright and fair manner.
Background on the Legal Complaint and Resolution
In September 2014, the FDA Office of Prescription Drug Promotion (OPDP) issued Pacira a Warning Letter related to certain promotional materials.
Pacira took actions to address the immediate FDA concerns and minimize further disruption to its business, but ultimately sought a court order to defend against any retroactive attempt to limit the broad indication for EXPAREL and restrict communications supported by the approved label.
Pacira and the individual physician plaintiffs were represented in this lawsuit by Ropes & Gray LLP. Pacira is also represented by Latham & Watkins LLP and Lowenstein Sandler LLP. (Original Source)
Shares of Pacira closed yesterday at $62.43, up $0.38 or 0.61%. PCRX has a 1-year high of $121.95 and a 1-year low of $35.78. The stock’s 50-day moving average is $58.20 and its 200-day moving average is $60.33.
On the ratings front, Pacira has been the subject of a number of recent research reports. In a report issued on November 9, Leerink Swann analyst Jason Gerberry reiterated a Hold rating on PCRX, with a price target of $52, which represents a potential downside of 16.7% from where the stock is currently trading. Separately, on November 3, Canaccord Genuity’s Corey Davis reiterated a Buy rating on the stock and has a price target of $78.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Gerberry and Corey Davis have a total average return of 7.3% and 10.2% respectively. Gerberry has a success rate of 53.2% and is ranked #526 out of 3616 analysts, while Davis has a success rate of 47.5% and is ranked #304.
The street is mostly Bullish on PCRX stock. Out of 6 analysts who cover the stock, 5 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $83.60, which represents a potential upside of 33.9% from where the stock is currently trading.
Pacira Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development, commercialization and manufacture of proprietary pharmaceutical products for use in hospitals and ambulatory surgery centers.