Benzinga | Sep 30, 2021 07:32AM EDT

Pacira Announces Commercial Production Underway With Enhanced EXPAREL Manufacturing Process At Swindon Facility

Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that it has successfully completed process validation and EXPAREL(r) (bupivacaine liposome injectable suspension) commercial production is now underway at its custom 200-liter manufacturing suite in Swindon, England. The suite was developed under a partnership with Thermo Fisher Scientific Pharma Services. Pacira expects to begin selling commercial product manufactured in the 200-liter suite before the end of 2021.

"The completion of our 200-liter validation process is a key milestone that doubles our manufacturing capacity to meet the growing demand for EXPAREL and places us on track to achieving EXPAREL gross margins that exceed 85 percent by 2024," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Importantly, this enhanced process has allowed us to add another layer of market exclusivity for EXPAREL through the issuance of a new Orange Book-listed patent that extends our proprietary position to January 2041."

In July 2021, the U.S. Food and Drug Administration (FDA) approved the company's enhanced manufacturing process and subsequently listed the U.S. Patent that claims composition of EXPAREL prepared by this process within its "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book). Process validation is required by FDA before any product from a new manufacturing process is commercially distributed for use by consumers to demonstrate the process will consistently produce drug product that meets predefined specifications.