Pacira BioSciences, Inc. PCRX announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA), seeking an approval for its lead drug Exparel (bupivacaine liposome injectable suspension) as a medicine for postsurgical analgesia. This validation confirms that the MAA submission is ready for the formal review process by the regulatory agency.
Pacira expects a decision from the Committee for Medicinal Products for Human Use (CHMP) in the second half of 2020. The MAA for Exparel is backed by the clinical evidence in several surgical indications including patients undergoing Cesarean section (C-section) and total knee arthroplasty (TKA).
Shares of Pacira were up 1.02% post this news on Tuesday. However, the stock has inched up 1.3% so far this year, underperforming the industry’s rally of 7.9%.
We would like to remind investors that Exparel is a liposome injection of bupivacaine, which is indicated for a single-dose administration into the surgical site to produce postsurgical analgesia in the United States. Last April, the FDA also approved the expansion of Exparel label to include administration via nerve block for prolonged regional analgesia. With this nod, Exparel became the first long-acting, single-dose nerve block available for patients undergoing upper extremity surgeries, such as total shoulder arthroplasty or rotator cuff repair.
Earlier this January, Pacira announced that the phase IV study on Exparel evaluating patients undergoing C-section achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption through 72 hours. The drug also attained a statistical importance for pain reduction.
Meanwhile, the company is conducting a phase IV study of Exparel on spinal fusion surgery. It is also launching a series of phase IV studies on soft tissue procedures.
Pacira is also developing Exparel for its usage in pain management pertaining to various other surgeries and is also extending its label to address complications in pediatric patient population. There are currently no approved alternatives to opioids for tackling severe post-surgical pain in pediatric patients. Last December, the EMA issued a positive opinion on the company’s pediatric investigation plan (PIP) for Exparel to be applied as a medicine for postsurgical analgesia.
Exparel sales came in at $90.6 million for the first quarter of 2019, rising 22.4% year over year. The company’s efforts to widen its label for sales boost are encouraging.
Notably, Pacira has a partnership pact with Johnson & Johnson JNJ wherein the latter continues to support the uptake of Exparel with the help of its world class educational programs and orthopedic procedural solutions for Pacira.
In April 2019, Pacira acquired the privately held MyoScience, Inc. following which, the former added the latter’s iovera system, which is highly complementary to Exparel as a non-opioid therapy.
Zacks Rank & Other Stocks to Consider
Pacira currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR and Repligen Corp. RGEN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
Repligen’s earnings estimates have been revised 9.4% upward for 2019 and 9.8% upward for 2020 over the past 60 days. The stock has soared 52.6% year to date.
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