Pacira to Acquire MyoScience, Adding FDA-approved ioveraº System for Non-opioid Pain Control
-- Novel cryoanalgesia treatment highly complementary to EXPAREL --
-- Corporate name change to Pacira BioSciences to reflect expanding product portfolio --
-- Conference call today at
“We are delighted to announce this strategic acquisition, which is highly complementary to EXPAREL and underscores our corporate mission to provide an opioid alternative to as many patients as possible,” said
“We are pleased to enter into this transaction and are confident that Pacira is the ideal fit to build the ioveraº franchise given their commitment to and proven track record of expanding patient access to non-opioid options,” said
Novel ioveraº system highly complementary to EXPAREL
ioveraº is a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. Treated nerves are temporarily stopped from sending pain signals until the nerve regenerates over time and the function is restored. The effect is immediate, leading to decreased pain, opioid consumption and improved length of stay while improving physical function for patients. The product has been used in over 20,000 procedures with a growing body of clinical evidence supporting efficacy. Pacira believes that ioverao used in combination with EXPAREL has the potential for an additive effect with a higher likelihood for a completely opioid-free patient journey. The ioveraº system is 510k cleared in the U.S. for the blocking of pain, pain relief, and symptoms associated with osteoarthritis of the knee as well as general surgical use.
Treatment results with ioveraº:
- Decreased knee pain. More than 75 percent of the patients who received ioveraº treatment continued to experience pain relief at 150 days.1
- Less stiffness. More than 50 percent of the patients treated with the ioveraº system experienced less stiffness 12 weeks after treatment.1
- Improved physical function. Majority of the patients in the ioveraº treatment group had improved physical function at 150 days.1
- Fewer opioid prescriptions. Patients who received ioveraº treatment requested 45 percent fewer opioid prescription at 12 weeks after knee replacement surgery.2
- Reduction in knee pain. 12 weeks after surgery, the majority of patients who received ioveraº treatment experienced less pain.2
- Faster recovery. Postsurgical recovery was much faster in patients who received ioveraº treatment before knee replacement surgery.2
Osteoarthritis compromises the quality of life of more than 27 million Americans, with approximately 25% of knee osteoarthritis sufferers complaining of pain while performing daily activities (walking, climbing stairs, kneeling, etc.)1. Osteoarthritis is also associated with a higher likelihood of opioid use with as many as 30% of presurgical patients with end-stage knee, hip or spine osteoarthritis using prescription opioids, according to data published in Arthritis Care & Research. The effect of this disease on
Terms of the Agreement
Under the terms of the agreement, Pacira will make an initial payment of
The transaction is expected to close in
Today’s Conference Call and Webcast Reminder
The Pacira management team will host a conference call to discuss the transaction today,
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 4468857. The replay of the call will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. 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
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Warnings and Precautions Specific to EXPAREL: Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials. Warnings and Precautions for Bupivacaine-Containing Products: Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias, sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use. Full Prescribing Information is available at www.EXPAREL.com.
The ioverao 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.1 The ioverao 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 ioverao system is not indicated for treatment of central nervous system tissue.
Important Safety Information
The ioverao 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 the company’s future expectations, plans, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “could” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the failure to complete the transaction or realize anticipated benefits and synergies from the transaction; the ability to successfully integrate ioverao and MyoScience into the company’s existing business; the commercial success of ioverao, the success of the company’s sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; and other factors discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the
1Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.
2Dasa, V. et al. “Percutaneous freezing of sensory nerves prior to total knee arthroplasty.” The Knee (2016) p523-528.
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