NEW YORK, June 30, 2021 (GLOBE NEWSWIRE) – Mesoblast Limited (Nasdaq: MESO; ASX: MSB), the world’s leading provider of allogeneic cellular drugs for inflammatory disease, today announced an update on its strategy for introducing Rexlemestrocel-L to patients in the United States (USA) with chronic low back pain (CLBP) due to degenerative disc disease (DDD) that is refractory to available therapies, including opioids. Opioid overuse in this patient population continues to be the focus of US health policymakers, regulators, patients and physicians as more than 50% of US opioid prescriptions are for the treatment of CLBP.1,6,7
Mesoblast has filed an application and expects to hold a Type C meeting with the U.S. Food & Drug Administration (FDA) this quarter to pave the way for U.S. approval of Rexlemestrocel-L following the recently completed Phase 3 Study with 404 patients to discuss patients with chronic inflammatory back pain due to degenerative disc disease.
“We look forward to discussing the most efficient way forward with the FDA, given the sustained pain reduction for at least two years and the opioid-sparing effects of a single administration of Rexlemestrocel-L observed in the most recent phase 3 study “said Dr. Fred Grossman, Mesoblast Chief Medical Officer.
Mesoblast plans to use the results of a planned US study to support potential product approvals in both the US and the EU by including 20% EU patients to provide regulatory harmonization, cost-effectiveness and streamlined schedules without an EU -Start study. In line with this strategy, Mesoblast and its partner in Europe and Latin America, Grünenthal, have changed their cooperation agreement so that Mesoblast can receive payments of up to US $ 112.5 million, including US $ 17.5 million, prior to launch in the EU -Dollar. Received when certain clinical and regulatory milestones are met and reimbursement targets are met. The cumulative milestone payments could reach $ 1 billion depending on the final outcome of the Phase 3 trials and patient adoption. Mesoblast will also receive tiered double-digit royalties on product sales under the original agreement.
About chronic low back pain due to degenerative disc disease
Chronic low back pain (CLBP) affects approximately 10-15% of the adult population, equivalent to more than 30 million people in the United States and nearly 40 million people in the EU5.1 Degenerative disc disease (DDD), which causes discogenic pain, is the most common etiology of CLBP in adults.4,5 Over 7 million patients in the United States and EU5 are thought to have CLBP, which is caused by degenerative disc disease, 4-6 a disease that causes inflammation and degeneration of the intervertebral discs on various factors such as age, trauma or genetic predisposition.
Back pain is more disabling than any other disease and has significant direct and indirect costs to the health system6, including the overuse of opioids in this population. There are few treatment options for patients with CLBP who have failed conservative therapy, including opioids, spinal injections, and surgery (e.g., spinal fusion or total disc arthroplasty). 3 despite the fact that opioids have been associated with serious and potentially life-threatening side effects and have shown no effectiveness in treating CLBP.3,8,9 In 2018, more than 67,000 drug overdose deaths occurred in the United States10, of which nearly 47,000 (70%) were opioid related.
Mesoblast is a global leader in the development of allogeneic (ready-to-use) cellular drugs for the treatment of serious and life-threatening inflammatory diseases. The company has used its proprietary mesenchymal cell therapy technology platform to establish a broad portfolio of late-stage product candidates that respond to severe inflammation by releasing anti-inflammatory factors that counteract and modulate multiple effector arms of the immune system, resulting in a significant reduction in the damaging inflammatory process.
Mesoblast has a strong and extensive global portfolio of intellectual property that will be protected in all major markets until at least 2040. The company’s proprietary manufacturing processes result in cryopreserved commercial cellular drugs on an industrial scale. These cell therapies with defined pharmaceutical release criteria should be available to patients worldwide.
Mesoblast has completed phase 3 studies with Rexlemestrocel-L in advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft-versus-host and moderate to severe acute respiratory distress syndrome. Two products have been commercialized by Mesoblast’s licensees in Japan and Europe, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has offices in Australia, the US and Singapore and is listed on the Australian Securities Exchange (MSB) and the Nasdaq (MESO). For more information, please visit www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
- Decision Resources: 2015 Chronic Pain Report.
- Abdel Shaheed C, Maher CG, Williams KA, Day R, McLachlan AJ. Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain: a systematic review and meta-analysis. JAMA Intern Med 2016; 176 (7): 958-68
- Hudson TJ, Edlund MJ, Steffick DE, Tripathi SP, Sullivan MD. Epidemiology of Regularly Prescribed Opioid Use: Results of a National Population-Based Survey. J Pain Symptom Manage 2008; 36 (3): 280-8
- DePalma MJ et al. What causes chronic low back pain and does age play a role? Pain med. 2011; 12: 224-233
- Peng BG. Pathophysiology, diagnosis and treatment of discogenic lower back pain. World J Orthop. 2013 April 2013; 4 (2): 42-52
- Williams, J., NG, Nawi, Pelzter, K. (2015) Risk Factors and Disability Associated with Low Back Pain in Older Adults in Low- and Middle-Income Countries. Results of the WHO Study on Global Aging and Adult Health (SAGE). Plus one. 2015; 10 (6): e0127880
- Zigler, J. et al. Comparison of total lumbar disc replacement with surgical spinal fusion for the treatment of degenerative disc disease on one level: a meta-analysis of 5-year results from randomized controlled trials. Glob Spine J. 2018; 8 (4): 413-23
- Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids versus placebo or other treatments for chronic low back pain. Cochrane Database Syst Rev 2013 (8): CD004959
- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The efficacy and risks of long-term opioid therapy for chronic pain: a systematic review for a workshop of the National Institutes of Health Pathways to Prevention. Ann Intern Med 2015; 162 (4): 276-86
- Annual Drug-Related Risks and Outcomes Monitoring Report USA, 2019. Centers for Disease Control and Prevention
This release contains forward-looking statements relating to future events or our future financial performance that involve known and unknown risks, uncertainties and other factors that could cause our actual results, activities, performance or achievements to differ materially from future results. Levels of activity, achievement or achievement expressed or implied in these forward-looking statements. We make such forward-looking statements in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results could differ from those anticipated in such forward-looking statements, and the differences could be material and adverse. Forward-looking statements include, but are not limited to, statements about potential milestone and royalty payments that may be received under the agreement with Grunenthal, the commencement, timing, progress and results of mesoblast’s preclinical and clinical studies, and mesoblast’s research and development programs ; Mesoblast’s ability to initiate, enroll, and successfully complete product candidates in clinical trials, including multinational clinical trials; Mesoblast’s ability to improve its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities, and product marketing activities, if any; the commercialization of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance regarding the use of stem cell-based therapies; the possibility that Mesoblast’s product candidates, if any, will be withdrawn from the market due to side effects or patient death; the potential benefits of strategic collaborative arrangements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property in its product candidates, and Mesoblast’s ability to successfully defend them in alleged infringement cases; the level of protection Mesoblast can establish and maintain for its product candidates and intellectual property technologies Estimates of Mesoblast’s expenses, future revenues, capital requirements, and additional funding requirements; Financial performance of mesoblast; Developments in relation to mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release along with our Risk Factors, in our most recent SEC filings, or on our website. Uncertainties and risks that could cause Mesoblast’s actual results, performance or accomplishments to differ materially from those expressed or implied in such statements and accordingly you should not place undue reliance on these forward-looking statements. We assume no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or for any other reason.
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