Pacira Announces Commercial Production Underway with Enhanced EXPAREL Manufacturing Process at Swindon Facility
Marks key step in achieving EXPAREL gross margins that exceed 85 percent by 2024
PARSIPPANY, N.J., Sept. 30, 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 that it has successfully completed process validation and EXPAREL® (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.
About Pacira BioSciences
Pacira BioSciences, Inc. (Nasdaq: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients’ journeys along the neural pain pathway. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.
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. Safety and efficacy have not been established in other nerve blocks. Since its launch, EXPAREL has been used in over nine million patients. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information for Patients
EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.
Pacira BioSciences, Inc.
Susan Mesco, (973) 451-4030
Coyne Public Relations