NEW YORK, Dec. 15, 2021 (GLOBE NEWSWIRE) – Mesoblast Limited (Nasdaq: MESO; ASX: MSB), a global leader in allogeneic cellular drugs for inflammatory diseases, today announced that it has received comments from the Food & Drug Administration United States (FDA) Office of Tissues and Advanced Therapies (OTAT) on the rexlemestrocel-L Phase 3 program in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including including opioids.
Mesoblast plans to conduct an additional Phase 3 trial in the United States that could support submissions for possible approval in the United States and the EU. The essay will include at least 20% of subjects from the EU to support global submission plans. After reviewing the data from the completed Phase 3 trial, OTAT accepted Mesoblast’s proposal to reduce pain at 12 months as the primary endpoint of the next trial, with functional improvement and reduced use of opioids as secondary endpoints.
If this trial is successful and results in EU regulatory approval, Mesoblast will be eligible to receive payments of up to US $ 112.5 million ahead of the product’s launch in the EU, from its partner. in Europe and Latin America, GrÃ¼nenthal, including US $ 17.5 million already received, if certain clinical and regulatory milestones are met and reimbursement targets are met. Cumulative milestone payments could reach US $ 1 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast will also receive double-digit tiered royalties on product sales.
In the United States, the excessive use of opioids in this patient population, with more than 50% of opioid prescriptions in the United States for the treatment of chronic low back pain,1-3 continues to be a major unmet medical need and a priority for healthcare policy makers, regulators and pharmaceutical companies. A key goal is to demonstrate reduction in pain and opioid use and to position rexlemestrocel-L as a potential opioid sparing agent.
About chronic low back pain due to degenerative disc disease
Chronic low back pain (LCBP) affects around 10 to 15% of the adult population, equivalent to more than 30 million people in the United States and almost 40 million people in the EU5.1 Degenerative disc disease (DDD) causing discogenic pain is the most common etiology of chronic low back pain in adults.6.7 It is believed that over 7 million patients in the US and EU5 suffer from chronic low back pain caused by degenerative disc disease,2,6,seven a disease that involves inflammation and degeneration of the intervertebral discs due to a variety of factors, including age, trauma, or genetic predisposition.
Back pain causes more disability than any other condition and inflicts substantial direct and indirect costs on the health care system2, including the excessive use of opioids in this patient population. There are few treatment options for patients with CLBP who fail conservative therapy, including opioids, spinal injections, and surgery (eg, spinal fusion or total disc arthroplasty).3 Over 50% of opioid prescriptions in the United States are for the treatment of chronic low back pain,1, 4-5 despite the fact that opioids are associated with serious and potentially fatal side effects and have not been shown to be effective in the treatment of chronic low back pain.5, 8.9 In 2018, more than 67,000 drug overdose deaths occurred in the United States10 of which nearly 47,000 (70%) were related to opioids.
About the mesoblast
Mesoblast is a world leader in the development of allogeneic (ready-to-use) cellular drugs for the treatment of serious and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage 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 intellectual property portfolio with protection extending to at least 2041 in all major markets. The Company’s proprietary manufacturing processes produce cryopreserved and ready-to-use cellular drugs on an industrial scale. These cell therapies, with defined pharmaceutical release criteria, should be readily available to patients around the world.
Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults, including acute steroid refractory graft versus host disease and moderate to severe acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been marketed in Japan and Europe by the licensees of Mesoblast, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has offices in Australia, the United States 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: Chronic Pain Report 2015.
- Williams, J., NG, Nawi, Pelzter, K. (2015) Risk factors and disability associated with low back pain in older people in low- and middle-income countries. Results of the WHO Study on Global Aging and Adult Health (SAGE). PloS One. 2015 ; 10 (6): e0127880
- Zigler J, et al. Comparison of total lumbar disc replacement with surgical spinal fusion for the treatment of single-level degenerative disc disease: a meta-analysis of the 5-year results of randomized controlled trials. Glob Spine J. 2018; 8 (4): 413â23
- 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 Med Intern 2016; 176 (7): 958â68
- Hudson TJ, Edlund MJ, Steffick DE, Tripathi SP, Sullivan MD. Epidemiology of regular use of prescribed opioids: results of a national population survey. J Pain Symptom Manage 2008; 36 (3): 280-8
- DePalma MJ, et al. What is the source of chronic low back pain and does age play a role? Medium Pain. 2011; 12: 224-233
- Peng BG. Pathophysiology, diagnosis and treatment of low back pain. World J Orthop. April 18, 2013; 4 (2): 42-52
- 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 System Rev 2013 (8): CD004959
- Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The effectiveness 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 Med Intern 2015; 162 (4): 276-86
- Drug Risk and Outcome Surveillance Annual Report United States, 2019. Centers for Disease Control and Prevention
This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or actual accomplishments differ materially from any future results, levels of activity, performance or achievements expressed or implied by such 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 interpreted as a guarantee of future performance or results, and actual results may differ from the results anticipated in such forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, without limitation, statements regarding the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates, enroll and complete clinical studies, including multinational clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; marketing of Mesoblast’s product candidates, if approved; regulatory or public perceptions and market acceptance regarding the use of stem cell therapy; the possibility that Mesoblast’s product candidates, if any, will be withdrawn from the market due to adverse events or patient deaths; the potential benefits of strategic collaboration agreements 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 cases of suspected infringement; the extent of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; Mesoblast’s expense estimates, future income, capital requirements, and its additional funding requirements; the financial performance of Mesoblast; developments relating to Mesoblast’s competitors and industry; and pricing and reimbursement of Mesoblast product candidates, if approved. You should read this press release, along with our risk factors, in our most recent reports filed with the SEC or on our website. The uncertainties and risks which may cause Mesoblast’s actual results, performance or achievements to differ materially from those which may be expressed or implied by such statements, and therefore, you should not place undue reliance on such statements prospective. We assume no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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