STAINES-UPON-THAMES, United
Kingdom, April 30, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, announced
today that it is supporting an investigator-initiated clinical
study at Massachusetts General Hospital evaluating the potential
benefits of inhaled nitric oxide as a treatment for pulmonary
complications in patients infected with COVID-19. Mallinckrodt's support to Massachusetts General
Hospital includes providing funding as well as
INOmax® (nitric oxide) gas, for
inhalation, to facilitate the study.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8715451-mallinckrodt-and-massachusetts-general-hospital-study-inomax-covid-19-effectiveness/
The study is titled "Inhaled Nitric Oxide Gas Therapy in
Mechanically Ventilated Patients with Severe Acute Respiratory
Syndrome in COVID-19."
"Data suggest that inhaled nitric oxide may have an important
role in helping patients with acute respiratory distress syndrome
(ARDS) to achieve normal oxygen levels in the blood," said
Lorenzo Berra, M.D., Medical
Director of Respiratory Care at Massachusetts General Hospital.
"The trial we are conducting will help us gain critical insights
into the potential effectiveness of INOmax in treating ARDS in
critically ill COVID-19 patients."
The primary focus of the study is to assess the potential
efficacy of inhaled nitric oxide to rapidly reverse hypoxemia
(abnormally low oxygen levels in the blood) in patients with severe
COVID-19 lung complications . Specifically, it will determine the
difference in oxygenation in patients after 48 hours of treatment.
Secondary objectives include evaluating the time it takes for
patients who are breathing air to reach normoxia (normal oxygen
levels in the blood) for at least 24 hours; the proportion of
patients who achieve normoxia during the first 28 days after
enrollment; and the patient survival rate at 28 days and 90 days,
among other objectives.
"Patients around the world are in need of science-based
therapies that can effectively fight this life-threatening disease,
and Mallinckrodt is committed to
assisting health providers and government agencies to research and
identify possible solutions to help relieve this global crisis,"
said Steven Romano, M.D.,
Executive Vice President and Chief Science Officer at Mallinckrodt. "We are extremely pleased to
support Massachusetts General Hospital in these research efforts to
potentially bring a new therapeutic option to physicians and
patients who need it most."
The trial initiation follows Mallinckrodt's earlier announcement of a research
project in Canada. On April 1, Mallinckrodt
and Novoteris LLC, a clinical stage medical device and
pharmaceutical developer, announced that the companies received
approval from Health Canada to begin a pilot trial of high-dose
inhaled nitric oxide therapy to treat the COVID-19 infection and
associated lung complications. Enrollment is expected to begin in
the coming days.
More than 170 hospitals and health systems in the U.S. have
reported using INOmax as an experimental treatment for pulmonary
complications of COVID-19 patients.1 The current
trial will enable formal data collection in a structured study of
the efficacy and safety of inhaled nitric oxide in patients with
pulmonary complications of COVID-19.
Mallinckrodt encourages hospitals to
contact the company's Customer Care center 1-877-566-9466 with any
questions related to INOmax. The Customer Care team is available 24
hours a day, seven days a week to respond to inquiries.
INOmax has been on the market in the U.S. since 2000 and is
indicated for the treatment of term and near-term neonates with
hypoxic respiratory failure associated with pulmonary hypertension.
The safety and efficacy of INOmax to treat COVID-19 infections and
associated lung complications have not been established by the U.S.
Food and Drug Administration.
COVID-19 is a respiratory illness that can spread from person to
person. It is caused by a novel coronavirus. Patients with COVID-19
may have mild to severe respiratory illness that can include
symptoms such as cough, fever and shortness of breath.2
In severe cases, COVID-19 can cause ARDS – a disorder in which
fluid leaks into the lungs, making breathing difficult or
impossible – and can lead to multi-organ failure and sometimes
death.2,3
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 Media Inquiries
Ron Bartlett
H+K Strategies
Senior Vice President
M: +1 813 545 2399
ron.bartlett@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-2000808 04/20
References
1 Mallinckrodt, Data on
File April 28, 2020.
2 Centers for Disease Control and Prevention Fact
Sheet. What you need to know about coronavirus disease 2019
(COVID-19).
3 Matthay MA, Aldrich JM, Gotts, JE. Treatment for
severe acute respiratory distress syndrome from
COVID-19. Lancet Respir Med. 2020. Published
Online March 20,
2020. https://doi.org/10.1016/S2213-2600(20)30127-2.
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SOURCE Mallinckrodt Pharmaceuticals