Release Details

STAINES-UPON-THAMES, United Kingdom, March 4, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced data from a retrospective cohort analysis that assessed the potential resource and cost impact of continuation of systemic treatment (ST) on healthcare utilization among U.S. patients with cutaneous T-cell lymphoma (CTCL). The analysis included 1,081 patients with CTCL with continuous enrollment three months before and six months after initiation of ST.

Results of the study were published online in an eposter on Friday, March 1, 2019, and were presented on Saturday, March 2 at 2:00 p.m. EST in an oral discussion at the 2019 American Academy of Dermatology Annual Meeting in Washington, D.C.

The intended audience of this study is population-based decision makers with knowledge and expertise in the area of health care economic analysis and its limitations.

"This is one of the first studies of its kind to look at the potential resource and cost impact of continuation of systemic therapy for CTCL and demonstrates our commitment to provide data to support informed decision-making," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "It is an important addition to the body of knowledge on CTCL, as examining resource utilization and costs can lead to improvements in healthcare overall."

Study Details

• A retrospective cohort analysis examined health insurance claims databases from 2010 to 2015 to assess the impact of continuation of ST on healthcare utilization in U.S. patients with CTCL.
• Data were examined for 1,081 patients with CTCL with continuous enrollment three months before and six months after initiation of ST.
• ST continuation was defined as persistence to treatment for ≥180 days without a gap of 45 days or more.
• Logistic regression was performed to assess factors associated with ST continuation.
• On average, ST treatment duration was 17.2 months (median 11.7 months).

Highlights

• Overall, 663 patients were continuers as defined; 418 were discontinuers (gap in ST treatment for 45 days or more in a ≥180 days period).
• Continuers had 0.04 monthly emergency room (ER) visits and discontinuers had 0.10 monthly ER visits (p=0.002).
• Continuers had 0.02 monthly hospitalizations and discontinuers had 0.06 monthly hospitalizations (p<0.001).
• Continuers had 0.17 monthly inpatients days and discontinuers had 0.57 monthly inpatient days (p<0.001).
• Continuers had monthly ER costs of $61.33 and discontinuers had monthly ER costs of $169.17 (p=0.02).

Study Limitations

The findings should be carefully interpreted:

• There is no recommended treatment duration for some STs.
• The six-month time frame selected for evaluation in this analysis is not based on recommended treatment duration for all STs in the study.
• The reasons why patients discontinued treatment are not known and cannot be evaluated.

The study was supported by Mallinckrodt.

"CTCL is diagnosed in approximately 3,000 new patients in the U.S. each year and treatments include a number of available systemic therapies for advanced disease," said Larisa Geskin, M.D., Associate Professor of Dermatology at Columbia University Medical Center and Director of the Comprehensive Skin Cancer Center at the Division of Cutaneous Oncology in the Department of Dermatology. "While there is no recommended duration of use for some systemic therapies, these data provide important insights on the potential impact of treatment discontinuation on healthcare costs and utilization."

About CTCL

Cutaneous T-cell lymphoma (CTCL) is an umbrella term for a group of non-Hodgkin lymphomas involving T lymphocytes that localize in the skin. It is a relatively rare cancer, with 2,500 to 3,000 new cases per year in the United States.¹ The age of onset of the condition is typically greater than 50 years, with the incidence rising significantly in the later decades of life.²

ABOUT MALLINCKRODT

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. The company's Specialty Brands 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; and analgesics. Its Specialty Generics and Amitiza segment includes specialty generic drugs, active pharmaceutical ingredients and AMITIZA^® (lubiprostone). 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.

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 Investor Relations Officer
314-654-3638
daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2019 Mallinckrodt. US-1900189 3/19

References

1. Agar NS, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/Sezary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. JCO. 2010;28:4730–4739.

2. Kim YH, Liu HL, Mraz-Gernhard S, et al. Long-term outcome of 525 patients with mycosis fungoides and Sezary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol. 2003;139:857–866.

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SOURCE Mallinckrodt plc