AP NEWS
Press release content from PR Newswire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from PR Newswire
Press release content from PR Newswire. The AP news staff was not involved in its creation.

Data on Acthar® Gel (Repository Corticotropin Injection) Therapy in Symptomatic Sarcoidosis Published in Therapeutic Advances in Respiratory Disease

November 26, 2019 GMT
Mallinckrodt logo
Mallinckrodt logo

STAINES-UPON-THAMES, United Kingdom, Nov. 26, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced findings from a large retrospective study of Acthar® Gel (repository corticotropin injection) in the treatment of the respiratory disease symptomatic sarcoidosis that assessed patient characteristics, treatment patterns, concomitant medication use and physicians’ assessments of treatment response. The study examined medical records from 302 patients with advanced symptomatic sarcoidosis, the majority of whom had comorbidities and had previously been treated with corticosteroids. The analysis showed that the use of Acthar Gel was associated with improved overall health status in 95 percent of patients as reported by physicians’ assessments, with more than half of patients (54 percent) seeing improvements in two or more symptoms. In addition, there was an association observed between the use of Acthar Gel therapy and reduced overall use of other medications. Results of the study were recently published online in Therapeutic Advances in Respiratory Disease, an online, open-access peer-reviewed journal.

Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic sarcoidosis.1 Please see Important Safety Information for Acthar Gel below.

“Symptomatic sarcoidosis is a rare and clinically challenging multisystem disease2,3 with high-dose corticosteroids as the mainstay of therapy. Mallinckrodt is committed to better understanding patients who may need an alternative to corticosteroids,” said George Wan, Ph.D., Vice President and Global Head of Health Economics and Outcomes Research at Mallinckrodt. “This study examined records from a large group of patients with advanced symptomatic sarcoidosis, and as such provides real-world data to support the use of Acthar Gel therapy in clinical practice in appropriate patients.”

The study, titled “Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records,” evaluated patient records from 302 adult (≥18, mean age=51 years) patients who were treated with Acthar Gel in the previous 36 months at the time of data collection from September 2017 to November 2017.

Study Methods

Patients were required to have completed an individualized course of Acthar Gel therapy or received Acthar Gel for ≥6 months at the time of data collection. Records were analyzed from 98 physicians in a range of specialties, including pulmonology, rheumatology, primary care, dermatology, cardiology, ophthalmology, gastroenterology and neurology.

Additional Observations

The analysis found that patients had varied and individualized dosing regimens. The mean duration of Acthar Gel treatment was 32.5 weeks, with 61.6 percent of patients continuing treatment for ≥6 months.

According to physicians’ assessments of change in patient health status following Acthar Gel therapy, improvements were reported in: overall health status (95 percent) as measured by the question “What is the patient’s status as of the end of RCI therapy or the six months point in therapy for ongoing treatment patients?” In addition, physicians reported overall reduced symptoms (73 percent); improved lung function (38 percent); reduced inflammation (33 percent); reduction or discontinuation of corticosteroids (32 percent); and increased quality of life (32 percent).

Limitations

The analysis was conducted by Mallinckrodt. The company is also currently conducting a Phase 4, multicenter, randomized, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of Acthar Gel in the treatment of pulmonary sarcoidosis. Read more at: https://clinicaltrials.gov/ct2/show/NCT03320070.

About Sarcoidosis
Sarcoidosis is a challenging, yet manageable, rare multisystem disease.2,3 In some cases the symptoms may come and go throughout a lifetime. This is referred to as symptomatic sarcoidosis. In people with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body’s tissues.4 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, and skin.2 Over 90 percent of people with sarcoidosis suffer lung problems.4 Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases.5

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-1901951 11/19

References

1 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD, Inc.
2 Judson MA. The clinical features of sarcoidosis: a comprehensive review. Clin Rev Allerg Immunol. 2015;49:63-78.
3 Boughman 2016 Baughman RP, Field S, Costabel U, et al. Sarcoidosis in America. Analysis based on health care use. Ann Am Thorac Soc 2016;13:1244-1252.
4 Baughman RP, Culver DA, Judson MA. A concise review of pulmonary sarcoidosis. Am J Respir Crit Care Med. 2011;183:573-581.
5 Shigemitsu H, Patel HV, Schreiber MP. Extrapulmonary sarcoidosis. In: Judson MA, ed. Pulmonary Sarcoidosis: A Guide for the Practicing Clinician. Vol 17. New York, NY: Springer; 2014:149-186.

View original content to download multimedia: http://www.prnewswire.com/news-releases/data-on-acthar-gel-repository-corticotropin-injection-therapy-in-symptomatic-sarcoidosis-published-in-therapeutic-advances-in-respiratory-disease-300965058.html

SOURCE Mallinckrodt plc