Full Press Release Details
Completes Acquisition of Flexion Therapeutics and Strengthens Leadership Position in Non-Opioid Pain Management
complementary ZILRETTA to Pacira commercial offering --
portfolio offers end-to-end non-opioid solutions along the pain pathway --
TAMPA, FL and BURLINGTON, MA, November 19,
2021 - Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management
and regenerative health solutions, today announced the completion of its previously announced acquisition of Flexion Therapeutics, Inc.
"This is an exciting day for
Pacira BioSciences as this acquisition expands our industry leadership and marks a major milestone in our strategy to build a robust
offering of novel, non-opioid treatments to improve patient care along the neural pain pathway," said David Stack, Chief Executive
Officer of Pacira. "ZILRETTA is a highly complementary commercial asset that allows us to
provide physicians with another tool in their pain management armamentarium to tackle osteoarthritis earlier in the patient journey as
we continue to redefine the role of opioids as a last resort rescue medication. Importantly, ZILRETTA will diversify our revenue
stream, enhance our topline, and we believe it will provide meaningful synergies that we expect to drive substantial near- and long-term
accretion to our cash flows and earnings."
About Pacira BioSciences
Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed
to providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The company
is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac
electrical storm, chronic pain, and spasticity. Pacira has three commercial-stage non-opioid treatments: EXPAREL (bupivacaine
liposome injectable suspension), a long-acting, local analgesia currently approved for postsurgical pain management; ZILRETTA
(triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, injection indicated for
the management of osteoarthritis knee pain; and iovera , a novel, handheld device for delivering immediate, long-acting,
drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. 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. EXPAREL utilizes the company's
proprietary multivesicular liposomal drug delivery technology composed of a honeycomb of numerous, non-concentric, internal aqueous chambers
containing bupivacaine. After injection, bupivacaine is released over time, as the lipid membranes are absorbed, prolonging the duration
of action. EXPAREL is the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.
A single dose of EXPAREL provides 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 about EXPAREL
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.
2017, ZILRETTA (triamcinolone acetonide extended-release injectable suspension) was approved by the U.S. Food and Drug Administration
as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA
employs proprietary microsphere technology combining triamcinolone acetonide-a commonly administered, short-acting corticosteroid-with
a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week
16. Learn more at www.zilretta.com.
Indication and Select
Important Safety Information for ZILRETTA
Indication: ZILRETTA
is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of
repeat administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA
is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
Adverse Reactions: The
most commonly reported adverse reactions (incidence 1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZILRETTALabel.com for
full Prescribing Information.
The iovera system is used to destroy
tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the
application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated
with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee
experienced pain and system relief beyond 150 days. The iovera system's "1 90" Smart Tip configuration
(indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from
a separate nerve stimulator. The iovera system is not indicated for treatment of central nervous system tissue. Additional information
is available at www.iovera.com.
Important Safety Information for iovera
The iovera system is
contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria;
Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical
treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to:
bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation
(localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by
applying ice packs to the affected sites, and by taking over-the-counter analgesics.
Forward-Looking Statements
Any statements in this
press release about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing
the words "believes," "anticipates," "plans," "estimates," "expects," "intends,"
"may," "will," "would," "could," "can" and similar expressions, constitute
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements
include, without limitation, statements related to the acquisition of Flexion and the benefits thereof, Pacira's strategy, plans,
objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product
portfolio, development programs, patent terms and other statements that are not historical facts. Actual results may differ materially
from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among
others: the outcome of legal proceedings against Flexion and/or others relating to the transaction; risks associated with acquisitions,
such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming
or costly than expected or that the expected benefits of the transaction will not occur; risks related to future opportunities and plans
for Flexion and its products, including uncertainty of the expected financial performance of Flexion and its products; disruption from
the transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers;
the possibility that if Pacira does not achieve the perceived benefits of the transaction as rapidly or to the extent anticipated by
financial analysts or investors, the market price of Pacira's shares could decline; the impact of the worldwide COVID-19 (Coronavirus)
pandemic and related global economic conditions on Pacira's business and results of operations; the success of Pacira's sales
and manufacturing efforts in support of the commercialization of EXPAREL and iovera ; the rate and degree of market acceptance of
EXPAREL and iovera ; the size and growth of the potential markets for EXPAREL and iovera and Pacira's ability to serve