Oct 27, 2017   SOURCE: PR NewsWire

Patient Survey Studies Find Multiple Sclerosis Relapse is Underreported; Approximately Half of Patients Do Not Always Engage with Healthcare Practitioners During Relapse

STAINES-UPON-THAMES, United Kingdom, Oct. 27, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced results from two company-sponsored surveys - the Multiple Sclerosis in America 2017 Survey (Poster P805) and a national patient survey conducted by Harris Poll (Poster P1267) - that suggest patient-reported multiple sclerosis (MS) relapse rates may be higher than often thought. The surveys found that approximately one in every two patients experiencing a relapse do not always report it to their healthcare provider (HCP). The findings are being presented at MSParis2017, the 7(th) Joint ECTRIMS-ACTRIMS Meeting, from October 25-28, in Paris, France.

"The surveys provide valuable patient insights that underscore the need for further education about MS relapse and its treatment," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "Increased engagement and timely follow-up during and after relapse should be prioritized to enhance patient satisfaction with their treatment plan."

"Relapse Prevalence, Symptoms, and Health Care Engagement: Insights from Patients with Multiple Sclerosis from the Multiple Sclerosis in America 2017 Survey" [Poster P805] includes data of 5,311 patients with MS on the prevalence and characterization of MS relapse and HCP engagement during and after relapse. The annual survey was fielded online in the first quarter of 2017 by Health Union, LLC, a company that cultivates online communities for people with chronic health conditions, including MS. All participants were required to have been diagnosed with MS and to live in the U.S.

Key Findings

    --  72.2% reported having relapsing-remitting MS; 12.1% reported having
        secondary-progressive MS; 9.3% reported having primary-progressive MS;
        and 6.5% were unsure how to characterize their MS.
        --  Roughly three-quarters (74.8%) of respondents with a relapsing form
            of MS reported current use of disease-modifying therapies (DMTs).
    --  73.1% of respondents reported experiencing at least one relapse in the
        past two years.
        --  Annualized relapse rates amongst all respondents were: <1 per year
            (44.1%), 1-2 per year (35.5%), and >2 per year (20.2%).
    --  46.9% of respondents with relapses said they always or often contact
        their HCP during a relapse; 45.8% said they sometimes or rarely contact
        their HCP during a relapse; and 7.3% said they never contact their HCP
        during a relapse.
    --  Common reasons for patients not engaging their HCP during a relapse
        were: relapse is not severe enough (57.9%), HCP is unhelpful or didn't
        tell me I should (30.9%), medications are ineffective or not well
        tolerated (25.6%), preference to manage alone (24.4%), financial or
        insurance barriers (16.1%), or had medication on-hand (10.0%).
    --  More frequent patient engagement of an HCP during a relapse was
        associated with lower relapse frequency.
    --  In addition, patients were more satisfied with both their provider and
        their overall treatment plan when HCP follow-up occurred within one
        month of reporting of the relapse (both p<0.001).

Poster P805 Limitations

    --  Surveys reflect convenience samples, and are subject to participation
        bias and recall bias. Respondents may be different and non-generalizable
        to the MS adult population.
    --  Relapse was recalled over a two-year period. Relapses are more likely to
        occur over longer timeframes, so recoded one-year rates may be elevated.
    --  Validated scales/measures were not used throughout the survey;
        measurement properties were not formally assessed prior to use, leading
        to a potential lack of clear interpretability. Such challenges in
        conducting voice of patient research are not uncommon.

"Understanding Patient Underreporting of MS Relapses: Insights from a 2017 Survey of Patients with Multiple Sclerosis" [Poster P1267] highlights results from a survey of 250 adults (at least 18 years of age) with MS who had a relapse within the past three years. The survey, conducted online by Harris Poll on behalf of Mallinckrodt between March 14, 2017 and April 4, 2017, sought to determine the percentage of MS patients who do not consistently report symptoms of relapse to their physicians, as well as their reasons for underreporting.

Key Findings

    --  While most patients (91%) believe it is at least as important (if not
        more important) to treat relapses as their MS, half (51%) said they do
        not always contact their physician when they suspect they are
        experiencing a relapse.
        --  A majority of those who do not always report their suspected
            relapses cited their reason for not doing so as believing the
            relapse would resolve on its own and didn't need to be treated
            (67%).
    --  Regardless of their relapse-reporting behavior, patients had a similar
        understanding of the common indicators of a relapse.
    --  Patients who always reported suspected relapses were more likely versus
        those who did not to:
        --  strongly agree that their doctor has spent time educating them about
            the signs and symptoms that could indicate a relapse (54% vs. 24%);
        --  state that it is very important to monitor for signs and symptoms of
            a relapse (83% vs. 51%), report symptoms regardless of severity (83%
            vs. 51%), and seek treatment for their relapse (80% vs. 48%); and
        --  be very satisfied with prior steroid therapy (39% vs. 17%) and be
            willing to be treated again with IV steroids (94% vs. 65%).

The posters with additional study details are available on the Mallinckrodt website.

ABOUT MULTIPLE SCLEROSIS
MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).(1) An MS relapse, or flare-up, can bring new or worsening symptoms.(2) Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.(3)

ABOUT MALLINCKRODT
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; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. 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.

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. ©2017 Mallinckrodt. ARDUS/01-01/1017/0088 10/17.

CONTACTS

Media

Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com

Investor Relations

Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com

(1) Multiple Sclerosis Foundation. Get Educated-Common Questions-Multiple Sclerosis. Available at: https://msfocus.org/Get-Educated/Common-Questions#What is Multiple Sclerosis. Accessed July 21, 2017.
(2) National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Accessed April 19, 2016 at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS.
(3) Multiple Sclerosis Foundation. Symptoms of Multiple Sclerosis. Accessed October 17, 2017 at http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx.

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SOURCE Mallinckrodt plc