-- Data Presented at Annual Meeting of Consortium of Multiple Sclerosis Centers --
STAINES-UPON-THAMES, United Kingdom – June 1, 2018 – Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today presented interim data from the company-sponsored Observational Registry of H.P. Acthar® Gel (repository corticotropin injection) for Multiple Sclerosis (MS) Relapse patients at the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers, held in Nashville, Tenn.
The presentation was entitled “A Prospective Observational Registry of Repository Corticotropin Injection for the Treatment of Multiple Sclerosis Relapse: Baseline Characteristics and Interim Results1.” The poster can be accessed here.
Tunde Otulana, M.D., Chief Medical Officer at Mallinckrodt, said, “Despite recent advances in the treatment of MS, many patients still experience relapses and may only achieve an incomplete recovery following treatment. Over time, this may lead to an accrual of disability2,3,4. Mallinckrodt is committed to conducting studies in MS relapse patients treated with Acthar to collect valuable real-world data about their treatment patterns, MS relapse recovery and safety outcomes. We look forward to also learning more from data generated in Mallinckrodt’s ongoing Phase 4 pilot study to assess Acthar response and safety in patients with relapsing MS whose flares are not responding to initial high-dose corticosteroid therapy.”
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of acute exacerbations of MS in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease
Study Details and Key Findings
A Prospective Observational Registry of H.P. Acthar Gel for the Treatment of Multiple Sclerosis Relapse is enrolling patients and collecting demographic data to characterize the patient population who receive H.P. Acthar Gel to treat acute MS relapse. The study will describe treatment patterns, MS relapse recovery and safety outcomes. The goal is to enroll 160 patients at up to 54 sites over 36 months, with a target follow-up duration of up to 24 months. The primary endpoint in this study is the evaluation of the efficacy of the drug based on physical subscale of the MS Impact scale, version 1 (MSIS-29v1). The MSIS-29v1 is a well-validated, patient-rated outcome scale that measures the impact of MS on day-to-day life. Patients who have experienced a relapse are treated with H.P. Acthar Gel and are evaluated with the MSIS-29v1 at baseline, two months and six months following MS relapse. Further details on the study can be found on clinicaltrials.gov here.
Preliminary data on 80 patients (enrolled as of August 30, 2017 – intention-to-treat n = 62) found:
The current study is a prospective observational registry that collects real world data that describes how H.P. Acthar Gel is being used in clinical practice. Therefore, the study does not specify the dosing regimens that are employed by investigators or the use of various concomitant disease modifying treatments. The heterogeneity of these variables in the study population may result in increased variability in the results when compared to studies that control for these variables. The current study measures improvement of patients compared to their baseline measures, but as an observational study does not utilize placebo or active control groups as comparators. Hence, some of the improvement observed in the current study could be due to factors other than treatment with H.P. Acthar Gel.
ABOUT MULTIPLE SCLEROSIS
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).10 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes. More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.11
About H.P. Acthar Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning H.P. Acthar Gel including expectations with regard to the study described in this release, as well as future research plans and potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
Senior Communications Manager
Chief Public Affairs Officer
Mallinckrodt, the "M" brandmark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 05/18
1 Due BR, Becker PM, Coyle PK. A prospective observational registry of repository corticotropin injection for the treatment of multiple sclerosis relapse: baseline characteristics and interim results. 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers.
2 Goodin DS, Reder AT, Bermel RA, et al. Relapses in multiple sclerosis: relationship to disability. Mult Scler Relat Disord. 2016; 6:10-20.
3 Kalincik T. Multiple sclerosis relapses: epidemiology, outcomes and management. A systematic review. Neuroepidemiology. 2015; 44(4):199-214.
4 Lublin FD, Baier M, Cutter G. Effect of relapses on development of residual deficit in multiple sclerosis. Neurology. 2003; 61(11):1528-1532.
5 The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. Available at : https://www.mstrust.org.uk/a-z/expanded-disability-status-scale-edss. Accessed May 18, 2018.
6 Rakusa M, Cano SJ, Porter B, et al. A predictive model for corticosteroid response in individual patients with MS relapses. PLoS One. 2015; 10(3):e0120829.
7 Le Page E, Veillard D, Laplaud DA, et al. Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial. Lancet. 2015; 386(9997):974-981.
8 Martinelli V, Rocca MA, Annovazzi P, et al. A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS. Neurology. 2009; 73(22):1842-1848.
9 Thompson AJ, Kennard C, Swash M, et al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse in MS. Neurology. 1989; 39(7):969-971.
10 Multiple Sclerosis Foundation. Get Educated-Common Questions-Multiple Sclerosis. Available at: https://msfocus.org/Get-Educated/Common-Questions#What is Multiple Sclerosis. Accessed May 18, 2018.
11 National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Available at: http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Accessed May 18, 2018.