PR Newswire
STAINES-UPON-THAMES, United Kingdom, Oct. 1, 2019
STAINES-UPON-THAMES, United Kingdom, Oct. 1, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced positive top-line findings from its observational registry to assess treatment patterns and response to Acthar® Gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (MS) relapse. The results for the main subsets of patients are highly statistically significant for all the efficacy endpoints. Mallinckrodt plans to share the data at an upcoming medical meeting.
MS is a chronic, degenerative disease that can cause numerous impairments, including fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes, and some people with MS experience relapses while on standard therapies1.
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 Acthar Gel to be effective in speeding the resolution of acute exacerbations of MS. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. Please see Important Safety Information for Acthar Gel below.
The registry was designed to assess the characteristics of patients receiving Acthar Gel for MS exacerbations (sometimes referred to as "flares" or "relapses"), as well as the outcome at two months and whether or not the outcome was maintained at six months. The average age of patients was 47 years, and the mean duration of MS was 10 years at the start of the study. Registry data showed that patients treated with Acthar Gel reported significant improvements in symptoms associated with MS exacerbations at two months from baseline, as measured by the MS Impact Scale, version 1 (MSIS 29v1), the primary measure of the study. The response was sustained at six months. Physicians also reported an improvement in physical symptoms in patients treated with Acthar Gel, based on Expanded Disability Status Scale (EDSS) scores.
"Mallinckrodt is committed to generating data that helps clarify to the prescriber those patients appropriate for treatment with Acthar Gel to manage MS relapses," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The registry evaluated the effect of Acthar Gel in prospectively defined patients who were treated with Acthar Gel following an acute relapse. In addition, we look forward to Mallinckrodt's ongoing, randomized, double-blind, placebo-controlled OPTIONS study, which we anticipate will provide data on some of the more difficult-to-treat MS patients in the future."
About the Observational Registry of Acthar Gel for Multiple Sclerosis Relapse
The MSIS-29v1 is a scientifically rigorous, disease-specific, health-related, quality of life instrument that measures the patient's perspective on disease impact. It consists of two subscales assessing the physical and psychological impacts of MS.2
The EDSS is a clinician-administered assessment scale that measures neurological impairment. It is used to describe and monitor disease progression and is widely used to measure disease outcomes in clinical trials.3
A limitation of the study is that, as it was a registry, there was no control group.
The study and analysis were conducted by Mallinckrodt. Additional information about the study can be found here.
About Multiple Sclerosis
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).4 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.1
Acthar Gel (repository corticotropin injection) Indications
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
Contraindications
Warnings and Precautions
Adverse Reactions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's 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. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. 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 Acthar Gel including expectations regarding related clinical trials, its potential impact on patients and anticipated benefits associated with its use. 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.
CONTACTS
For Trade Media Inquiries
Caren Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
For Financial/Dailies Media Inquiries
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2019 Mallinckrodt. US-1901601 9/19
References
1 National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Available at: http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Accessed September 10, 2019.
2 Hobart J, Lamping D, Fitzpatrick R, Riazi A, Thompson A. The multiple sclerosis impact scale (MSIS-29) -- A new patient-based outcome measure. Brain 2001, 124: 962–973.
3 Kurtzke J: Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983, 33: 1444–1452.
4 Willis, BMJ Best Practice Multiple Sclerosis. October 2018. p. 4.
View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-announces-positive-top-line-findings-from-its-observational-registry-assessing-relapse-recovery-in-multiple-sclerosis-relapse-patients-treated-with-acthar-gel-repository-corticotropin-injection-300928259.html
SOURCE Mallinckrodt plc
Hinweis: ARIVA.DE veröffentlicht in dieser Rubrik Analysen, Kolumnen und Nachrichten aus verschiedenen Quellen. Die ARIVA.DE AG ist nicht verantwortlich für Inhalte, die erkennbar von Dritten in den „News“-Bereich dieser Webseite eingestellt worden sind, und macht sich diese nicht zu Eigen. Diese Inhalte sind insbesondere durch eine entsprechende „von“-Kennzeichnung unterhalb der Artikelüberschrift und/oder durch den Link „Um den vollständigen Artikel zu lesen, klicken Sie bitte hier.“ erkennbar; verantwortlich für diese Inhalte ist allein der genannte Dritte.