Exparel Concerns Weigh On Pacira Pharma, Brean Moves To Sidelines


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Brean Capital has downgraded Pacira Pharmaceuticals Inc (NASDAQ: PCRX) to Hold from Buy after the FDA said it is evaluating adverse event reports of local anesthetic systemic toxicity (LAST) with company's drug Exparel.

"We are downgrading Pacirato Hold from Buy for what we believe will amount to an increasingly difficult time marketing Exparel, especially in the face of future competition even just from other forms of extended release bupivacaine," analyst Jonathan Aschoff wrote in a note.

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Exparel And Outside Competition Concerns

The analyst noted competition from Heron Therapeutics Inc (NASDAQ: HRTX) is expected about two years from now, in addition to the myriad other late-stage companies evaluating post-operative pain drugs.

"We also believe that Exparel's lack of positive controls in its pivotal trials will be a disadvantage once similar drugs become available that have completed more informatively designed pivotal trials," Aschoff highlighted.


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Exparel, a local analgesic, was included in the FDA's first-quarter report of potential signals of serious risks and new safety information identified in adverse event reports. The FDA's AERS website indicates that the FDA is evaluating the need for regulatory action on Exparel due to potential signals of LAST.

On April 4, the FDA informed Pacira that a tracked safety issue (TSI) was created on March 10. The agency classified the TSI as standard, which is the lowest categorization priority. Pacira will provide an analysis of the issue to the FDA by the requested response date of August 4.

However, the analyst said the FDA gave no specific reason for creating the TSI, and Pacira's roughly 2 million Exparel patient safety database exposes no safety signals related to LAST.

Due to the latest developments, Aschoff widened his loss estimate for FY16 to $0.80 from $0.31.

Other Voices, Ratings And Recent Performance

This week, BMO analyst Gary Nachman initiated coverage on shares of Pacira Pharma with an Underperform rating and $36 price target.

Shares of Pacira Pharma fell 11.26 percent Thursday to close at $33.73 before touching a new 52-week low of $31.08. In Friday's pre-market session, the issue was up 1.27 percent at $34.16.


27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


Posted In: Analyst ColorBiotechLong IdeasNewsDowngradesHealth CarePrice TargetFDAAnalyst RatingsMoversTrading IdeasGeneralBOMBrean CapitalExparelGary NachmanJonathan Aschoff