Pacira Targets Opiod Addiction

05/17/2017 2:50 am EST

Focus: HEALTHCARE

John McCamant

Editor, Medical Technology Stock Letter

It's "steady of she goes" at Pacira Pharmaceuticals (PCRX); overall the firm reported a steady quarter of progress with a busy event calendar ahead, notes biotech expert John McCamant, editor The Medical technology Stock Letter.

In the first quarter, Exparel net product sales were $68 million compared with $64 million in Q1:16 and $71 million in Q4:16. The March guidance for full year 2017 net Exparel sales of $290 million-$310 million remains intact.

These results reflect the continued success of Exparel as an opioid sparing solution for post-surgical pain. Gross margins are forecast to stay in the 70% range this year, but rise to 85% once the U.K. manufacturing facilities are operational in 2018.

PCRX’s  three pillar growth strategy includes – driving education and awareness with patients, healthcare providers and payers about the need for opioid-sparing solutions; generating level one clinical data; and third, forming strategic collaborations with partners.

While still early since inception, the Company’s JNJ orthopedic partnership is moving along well, and Exparel’s Orange Book patent was extended to 2021.

Another sound partnership has been formed with BoneSmart.org, the largest active online orthopedic community in
the world with more than 2.8 million site visits in 2016 alone.

BoneSmart serves as an important website for patients planning or considering knee and hip replacement procedures and Pacira is working with them to address the use of opioids and the alternatives to opioids for orthopedic surgery.

Label expansion in total knee arthroplasty ( TKA) and nerve blocks are nearing, with both the positive Phase IV TKA trial announced in March plus two nerve block studies due this year. Both are label expansion studies that are advancing on schedule and continue to be on track to read out around mid-year.

In parallel, PCRX  is preparing to file a supplemental new drug application as soon as possible following positive data. Because it is a resubmission, just a six-month PDUFA review is expected with an estimated Q1:18 nerve block launch. A Phase 4 study of Exparel in spinal fusion surgery has data due in Q4:17.

At a high level, PCRX  education initiatives are raising awareness about non-opioid alternatives. The TKA success, further trials and the added emphasis on addressing the global opiod addiction epidemic should keep Pacira in a positive growth mode.

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