By Ciara Linnane, MarketWatch
Heron Therapeutics Inc. shares surged 30% Thursday, after the company announced positive developments for its treatment for postoperative pain that aims to reduce patient dependence on opioids.
Heron /zigman2/quotes/204568286/composite HRTX -1.26% unveiled positive results from two mid-stage studies of patients having knee replacement or breast enhancement surgery. It then said that its HTX-011, which was the focus of the two studies, has won breakthrough therapy designation from the U.S. Food and Drug Administration.
HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam and is intended for the management of postoperative pain. The FDA’s breakthrough therapy designation aims to speed up the development and review of drugs that treat serious conditions and that show signs of offering significant improvement over existing therapies.
“While this does not ensure FDA approval, it is certainly an extremely important independent indicator regarding the efficacy HTX-011 relative to all other currently available therapies, including Pacira Pharmaceutical Inc.’s Exparel,” said Janney analyst Ken Trbovich. Pacira /zigman2/quotes/202929053/composite PCRX +1.12% shares were down 12.1% in midday trade.
HTX-011 has consistently shown that it is more effective than bipuvicaine alone, something Exparel has rarely demonstrated, and is easier to administer, said Trbovich. Exparel is mixed with bupivacaine and diluted to fill six separate 20 mln syringes that are then injected multiple times around the knee, he said.
“In total Pacira’s procedure, which requires physician training, requires no less than 50 needle sticks,” said Trboivch. “By comparison, HTX-011 is instilled into the surgical site via a needle-free syringe.”
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Heron is expected to submit its new drug application in the second half of the year and could be approved and on the market by the second half of 2019, offering a major competitive threat to Exparel, he said.
On its call to discuss results of the study, Heron said its first target will be those hospitals and physicians that are current users of Exparel.
“Only after that will they begin the more difficult challenge of trying to convince those who use bupivacaine to convert to HTX-011,” said the analyst. He reiterated a sell rating on Pacira stock and $27 price target, or about 30% below its current trading level.
Evercore analysts said Heron stock remains a top pick and raised their price target to $80 from $56.
Heron shares have gained 121% in 2018, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +0.37% has gained about 3%.