Benzinga | Aug 2, 2021 08:01AM EDT

Pacira Reports FDA Approval Of Enhanced EXPAREL Manufacturing Process

-- New 200-liter suite doubles capacity to meet growing EXPAREL demand --

-- Patent covering enhanced manufacturing process extends proprietary position to January 2041 --

PARSIPPANY, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the company's enhanced manufacturing process for EXPAREL(r) (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.

"This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Launching this new manufacturing site marks an important milestone for Pacira that will allow us to double our capacity to meet the growing demand for EXPAREL, while simultaneously improving our gross margins and extending our market exclusivity into 2041."

In June 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, "Manufacturing of Bupivacaine Multivesicular Liposomes," claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in July 2021.