STAINES-UPON-THAMES, United
Kingdom, Feb. 27, 2020
/PRNewswire/ -- Mallinckrodt plc (NYSE:
MNK), a global biopharmaceutical company, announced today that it
will present new data from two studies of Acthar® Gel
(repository corticotropin injection) in multiple sclerosis (MS)
relapse. The data will be highlighted in poster presentations at
the Fifth Annual Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) Forum 2020, held Feb. 27-29 in West Palm
Beach, Florida.
"These studies underscore our commitment to patients with
difficult-to-treat MS relapse who continue to have symptoms and
disease exacerbations that don't resolve with standard therapy,"
said Tunde Otulana, M.D., Senior
Vice President and Chief Medical Officer at Mallinckrodt. "We look forward to sharing data
in MS relapse from two studies that seek to better understand this
patient population and Acthar Gel's potential role in MS
relapse."
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.1 Please see Important
Safety Information for Acthar Gel below.
These studies are sponsored by Mallinckrodt Pharmaceuticals and
include:
Top-line Results of a Prospective Observational Registry of
Repository Corticotropin Injection for the Treatment of Multiple
Sclerosis Relapse2
- The multicenter, prospective, observational registry sought to
characterize the adult patient population (≥18 years of age) being
treated with Acthar Gel for acute MS relapse and describe treatment
patterns, MS exacerbation recovery, and safety outcomes.
- The primary endpoint was: change from baseline to Month 2 as
measured by the MS Impact Scale, version 1 (MSIS-29v1) physical
subscale score.
- Patients were also assessed with the Expanded Disability Status
Scale (EDSS) and Clinical Global Impression of Improvement (CGI-I)
scale.
- Patients were followed for up to 24 months, and a minimum of
six months at 31 U.S. sites.
Study Design of the Randomized, Double-blind,
Placebo-Controlled OPTIONS Study of Repository Corticotropin
Injection for Acute Exacerbations of MS3
- Interim baseline patient characteristics from 50 percent
enrollment (n=32, ≥18 years of age) will be presented.
- The study is an ongoing, randomized, double-blind,
placebo-controlled parallel group pilot trial to assess the
efficacy and safety of Acthar Gel in patients who continue to
experience acute exacerbations of MS after treatment with high-dose
intravenous or oral corticosteroids.
- The study's primary objective is to generate an estimate of the
response rate for Acthar Gel and to assess its safety and
tolerability. The secondary objective is to assess the effect of
treatment on quality-of-life measures.
- Find more information about the OPTIONS trial here on the
ClinicalTrials.gov website.
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.5 More than eight in 10 people with MS will
experience a relapse, also known as a flare-up, exacerbation or
attack, that brings new or worsening symptoms.5,6
Acthar Gel (repository corticotropin injection)
Indications
Acthar® Gel (repository corticotropin injection)
is indicated for:
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic lupus erythematosus
- Monotherapy for the treatment of infantile spasms in infants
and children under 2 years of age
- The treatment of acute exacerbations of multiple sclerosis in
adults. Controlled clinical trials have shown 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
- Inducing a diuresis or a remission of proteinuria in nephrotic
syndrome without uremia of the idiopathic type or that due to lupus
erythematosus
- Treatment during an exacerbation or as maintenance therapy in
selected cases of systemic dermatomyositis (polymyositis)
- The treatment of symptomatic sarcoidosis
- Adjunctive therapy for short-term administration (to tide the
patient over an acute episode or exacerbation) in: psoriatic
arthritis, rheumatoid arthritis, including juvenile rheumatoid
arthritis (selected cases may require low-dose maintenance
therapy), ankylosing spondylitis
- Treatment of severe acute and chronic allergic and inflammatory
processes involving the eye and its adnexa such as: keratitis,
iritis, iridocyclitis, diffuse posterior uveitis and choroiditis,
optic neuritis, chorioretinitis, anterior segment inflammation
IMPORTANT SAFETY INFORMATION
Contraindications
- Acthar should never be administered intravenously.
- Administration of live or live attenuated vaccines is
contraindicated in patients receiving immunosuppressive doses of
Acthar.
- Acthar is contraindicated where congenital infections are
suspected in infants.
- Acthar is contraindicated in patients with scleroderma,
osteoporosis, systemic fungal infections, ocular herpes simplex,
recent surgery, history of or the presence of a peptic ulcer,
congestive heart failure, uncontrolled hypertension, primary
adrenocortical insufficiency, adrenocortical hyperfunction or
sensitivity to proteins of porcine origins.
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its
steroidogenic effects.
- Acthar may increase susceptibility to new infection or
reactivation of latent infections.
- Suppression of the hypothalamic-pituitary-axis (HPA) may occur
following prolonged therapy with the potential for adrenal
insufficiency after withdrawal of the medication. Adrenal
insufficiency may be minimized by tapering of the dose when
discontinuing treatment. During recovery of the adrenal gland
patients should be protected from the stress (e.g. trauma or
surgery) by the use of corticosteroids. Monitor patients for
effects of HPA suppression after stopping treatment.
- Cushing's syndrome may occur during therapy but generally
resolves after therapy is stopped. Monitor patients for signs and
symptoms.
- Acthar can cause elevation of blood pressure, salt and water
retention, and hypokalemia. Blood pressure, sodium and potassium
levels may need to be monitored.
- Acthar often acts by masking symptoms of other
diseases/disorders. Monitor patients carefully during and for a
period following discontinuation of therapy.
- Acthar can cause GI bleeding and gastric ulcer. There is also
an increased risk for perforation in patients with certain
gastrointestinal disorders. Monitor for signs of bleeding.
- Acthar may be associated with central nervous system effects
ranging from euphoria, insomnia, irritability, mood swings,
personality changes, and severe depression, and psychosis. Existing
conditions may be aggravated.
- Patients with comorbid disease may have that disease worsened.
Caution should be used when prescribing Acthar in patients with
diabetes and myasthenia gravis.
- Prolonged use of Acthar may produce cataracts, glaucoma and
secondary ocular infections. Monitor for signs and symptoms.
- Acthar is immunogenic and prolonged administration of Acthar
may increase the risk of hypersensitivity reactions. Neutralizing
antibodies with chronic administration may lead to loss of
endogenous ACTH activity.
- There is an enhanced effect in patients with hypothyroidism and
in those with cirrhosis of the liver.
- Long-term use may have negative effects on growth and physical
development in children. Monitor pediatric patients.
- Decrease in bone density may occur. Bone density should be
monitored for patients on long-term therapy.
- Pregnancy Class C: Acthar has been shown to have an embryocidal
effect and should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Adverse Reactions
- Common adverse reactions for Acthar are similar to those of
corticosteroids and include fluid retention, alteration in glucose
tolerance, elevation in blood pressure, behavioral and mood
changes, increased appetite and weight gain.
- Specific adverse reactions reported in IS clinical trials in
infants and children under 2 years of age included: infection,
hypertension, irritability, Cushingoid symptoms, constipation,
diarrhea, vomiting, pyrexia, weight gain, increased appetite,
decreased appetite, nasal congestion, acne, rash, and cardiac
hypertrophy. Convulsions were also reported, but these may actually
be occurring because some IS patients progress to other forms of
seizures and IS sometimes mask other seizures, which become visible
once the clinical spasms from IS resolve.
Other adverse events reported are included in the full
Prescribing Information.
Please see full Prescribing Information for
additional Important Safety 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 with regard to the studies
described in this release, as well as 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
Jim Heins
H+K Strategies
212-885-0463
jim.heins@hkstrategies.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. ©2020 Mallinckrodt. US-2000279 02/20
References
1 Acthar® Gel (repository
corticotropin injection) [prescribing
information]. Mallinckrodt ARD LLC.
2 Data on file. Mallinckrodt ARD, LLC, 2020. Kaplan
J, Miller T, Baker M, Due B, Zhao E. Topline results of a
prospective observational registry of repository corticotropin
injection for the treatment of multiple sclerosis relapse. Poster
to be presented at: The fifth annual Americas Committee for
Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum
2020; February 27-29, 2020; West
Palm Beach, FL.
3 Data on file. Mallinckrodt ARD, LLC, 2020.
Goldstick L, Miller A, Due B, Bauer W, Zhao E, Cohen J, Robertson
D, Wynn D. Study design of the
randomized, double blind, placebo-controlled options study of
repository corticotropin injection for acute exacerbations of RRMS.
Poster to be presented at: The fifth annual Americas Committee
for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum
2020; February 27-29, 2020; West
Palm Beach, FL.
4 Willis BMJ Best Practice Multiple Sclerosis.
October 2018. p. 4.
5 Multiple Sclerosis: Hope Through Research. National
Institute of Neurological Disorders and Stroke. 2012. Available at
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research#3215_29.
Accessed February 13, 2020.
6 Tillery EE, Clements JN, Howard Z. What's new in
multiple sclerosis? The Mental Health Clinician. 2017; 7(5)
213-220.
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SOURCE Mallinckrodt Pharmaceuticals