Pacira BioSciences begins commercial production of EXPAREL at Swindon facility
Pacira BioSciences (NASDAQ:PCRX) has completed the process validation of its custom 200-liter manufacturing suite in Swindon, England that was developed under a partnership with Thermo Fisher Scientific Pharma Services (NYSE:TMO).
With this, the company has begun the commercial production of EXPAREL (bupivacaine liposome injectable suspension) at the suite, and expects to begin selling before the end of 2021.
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).
EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
Dave Stack, Chairman and Chief Executive Officer of Pacira BioSciences, said, "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. 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."