Brean Capital Maintains Pacira Pharma (PCRX) at 'Buy'; FDA Request on EXPAREL Consistent with Views

Brean Capital affirms Pacira Pharma (NASDAQ: PCRX) with a Buy rating and $92 price target after the company announced that it completed an End-of-Review process with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for the use of EXPAREL (bupivacaine liposome injectable suspension) for administration as a nerve block to provide postsurgical analgesia.

Analyst Jonathan Aschoff commented, The FDA requested that new Phase 3 trials will be required for the broad nerve block label that Pacira desires, which is consistent with our prior notes claiming that label breadth was the issue and that new trials would likely be needed in order for the FDA to agree to a broad label. We believe that this outcome was becoming increasingly expected by investors, despite how quiet management was being about why it received a CRL in March, especially given the experience in infiltration where the FDA was concerned with specific promotion tactics in indications not tested in Phase 3. We would imagine the FDA knows that Exparel for nerve block will be used far beyond its Phase 3 indication of femoral nerve block, and therefore a narrow label for a narrow indication is simply inappropriate for Exparel. In our view, today's news is positive in that it resolves an unknown, and that the outcome matches our expectation. The design of the new trials still needs to be finalized, but they should be initiated by YE15. We anticipate three new Phase 3 trials, encompassing two additional surgical settings (shoulder and foot/ankle), as well as another femoral nerve block trial. We believe that the sNDA can now be refiled in 1H17, with approval and launch in 2H17.

For an analyst ratings summary and ratings history on Pacira Pharmaceuticals click here. For more ratings news on Pacira Pharmaceuticals click here.

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