STAINES-UPON-THAMES, United
Kingdom, March 12, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
commented that it is currently evaluating the limited published
evidence suggesting a potential role for inhaled nitric oxide
("iNO") as a supportive measure in treating those patients infected
with coronavirus (SARS-CoV-2) and having associated pulmonary
complications. The company has engaged with the U.S. Food and Drug
Administration (FDA), the National Institutes of Health (NIH) and
the Biomedical Advanced Research and Development Authority (BARDA)
on this matter; however, the safety and efficacy of iNO for
pulmonary complications associated with coronavirus have not been
established.
Mallinckrodt markets iNO as INOmax®
(nitric oxide) gas for inhalation in the U.S. for the treatment of
term and near-term neonates with hypoxic respiratory failure
associated with pulmonary hypertension. Please see Important Safety
Information below.
While nitric oxide has not been specifically studied or used to
treat COVID-19, in vitro it has demonstrated an inhibitory
effect on the replication cycle of severe acute respiratory
syndrome-related coronavirus (SARS-CoV).1 In another
study, investigators utilized iNO in the treatment of six patients
infected with SARS-CoV. This study compared the outcomes of
the six patients treated with iNO to eight
controls. Improvements in blood oxygenation, a reduction in
supplemental oxygen and a reduction in the amount of ventilator
support were achieved.2
A potential clinical manifestation of infection with many
respiratory viruses (such as coronaviruses or influenzas) is acute
respiratory distress syndrome (ARDS) - a disorder in which fluid
leaks into the lungs, making breathing difficult or impossible. iNO
has been evaluated in randomized controlled trials, both in
pediatric and adult patients with ARDS.3-7 In one
study, iNO elicited a partially dose dependent improvement in blood
oxygenation and decreased pulmonary artery pressure.3 In
a second trial, evaluating pediatric ARDS patients, improvements
were found in the composite measure of days alive or free of
ventilator support at day 28 of the trial (the last day
evaluated).8 There have been other trials evaluating iNO
in the context of ARDS, which have demonstrated mixed
results.9
In recent days, the company has submitted information to the NIH
regarding the potential to evaluate iNO in ARDS, informed BARDA of
the ongoing evaluation in this area and is in early discussions
with the FDA on the potential to submit a pre-Investigational New
Drug (IND) package in support of the potential use of iNO in
coronavirus-associated ARDS.
"Mallinckrodt is evaluating the
limited data presently available on inhaled nitric oxide as a
supportive measure for treating coronavirus-associated lung
complications," said Steve Romano,
M.D., Executive Vice President and Chief Scientific Officer at
Mallinckrodt. "We are in ongoing
discussions with scientific, regulatory and governmental
organizations regarding the potential use of iNO in assisting with
this global emergency, and are committed to determining whether iNO
has a benefit for those diagnosed with COVID-19. We will share
updates as information becomes available."
INDICATION
INOmax® (nitric oxide) gas, for inhalation, is indicated to improve
oxygenation and reduce the need for extracorporeal membrane
oxygenation in term and near-term (>34 weeks gestation) neonates
with hypoxic respiratory failure associated with clinical or
echocardiographic evidence of pulmonary hypertension in conjunction
with ventilatory support and other appropriate agents.
IMPORTANT SAFETY INFORMATION
- INOmax is contraindicated in the treatment of neonates
dependent on right-to-left shunting of blood.
- Abrupt discontinuation of INOmax may lead to increasing
pulmonary artery pressure and worsening oxygenation.
- Methemoglobinemia and NO2 levels are dose dependent. Nitric
oxide donor compounds may have an additive effect with INOmax on
the risk of developing methemoglobinemia. Nitrogen dioxide may
cause airway inflammation and damage to lung tissues.
- In patients with pre-existing left ventricular dysfunction,
INOmax may increase pulmonary capillary wedge pressure leading to
pulmonary edema.
- Monitor for PaO2, inspired NO2, and methemoglobin during INOmax
administration.
- INOmax must be administered using a calibrated FDA-cleared
Nitric Oxide Delivery System.
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 inhaled nitric oxide ("iNO") and the Company's iNO
product, including statements with regard to potential regulatory
developments, the potential impact of iNO 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
Government Affairs
Mark
Tyndall
Senior Vice President, Government Affairs
202-383-0090
mark.tyndall@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-2000421 03/20
References
- Akerstrom S et. Al. Nitric oxide inhibits the Replication Cycle
of Severe Acute Respiratory Syndrome Coronavirus. J Virol 2005;
79(3):1966-9.
- Chen L. Inhalation of nitric oxide in the treatment of acute
respiratory syndrome: a rescue trial in Beijing. Clinical Infectious Diseases 2004;
39(10):1531-5.
- Gerlach H, Keh D, Semmerow A, et al. Dose-response
characteristics during long-term inhalation of nitric oxide in
patients with severe acute respiratory distress syndrome: a
prospective, randomized, controlled study. Am J Respir Crit Care
Med. 2003;167(7):1008-15.
- Payen D, Valle B. Results of the French prospective
multicentric randomized double-blind placebo-controlled trial on
inhaled nitric oxide (NO) in ARDS. Intensive Care Med.
1999;25(1432-1238 (Electronic)):S166.
- Dellinger RP, Zimmerman JL, Taylor RW, et al. Effects of
inhaled nitric oxide in patients with acute respiratory distress
syndrome: results of a randomized phase II trial. Inhaled Nitric
Oxide in ARDS Study Group. Crit Care Med. 1998;26(1):15-23.
- Michael JR, Barton RG, Saffle JR, et al. Inhaled nitric oxide
versus conventional therapy: effect on oxygenation in ARDS. Am J
Respir Crit Care Med. 1998;157(5 Pt 1):1372-80.
- Troncy E, Collet JP, Shapiro S, et al. Inhaled nitric oxide in
acute respiratory distress syndrome: a pilot randomized controlled
study. Am J Respir Crit Care Med. 1998;157(5 Pt 1):1483-8.
- Bronicki RA, Fortenberry J, Schreiber, M, Checchia PA, Anas NG.
Multicenter randomized controlled trial of inhaled nitric oxide for
pediatric acute respiratory distress syndrome. The Journal of
Pediatrics 2015. 66(2):365‐9.
- Hunt JL, Bronicki RA, Anas N. Role of inhaled nitric oxide in
the management of severe acute respiratory distress syndrome.
Frontiers in Pediatrics. 2016;4:1-7.
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SOURCE Mallinckrodt Pharmaceuticals