FDA Clears Nitric Oxide Inhalation Device For MRI Procedues

• Enables continuity of care and uninterrupted INOMAX (nitric oxide) for inhalation therapy for neonates requiring MRI procedures
• Increases INOMAX delivery options

Chesterfield, UK -- Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared INOmax DSIR Plus MRI device for delivery of INOMAX (nitric oxide) for inhalation during MRI procedures.

The INOmax DSIR Plus MRI delivery system is indicated for delivery of INOMAX (nitric oxide) for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide (NO) to the patient. The INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.

"Neonates being treated with INOmax frequently have multiple medical concerns that may need diagnostic imaging, such as an MRI scan, to guide medical management. Before INOmax DSIR Plus MRI, physicians had to make the difficult decision to take the risk of interrupting INOmax treatment so that imaging could be done," said Dr. Stephen Welty, Professor of Pediatrics and leading neonatologist. "Now, we can deliver uninterrupted inhaled nitric oxide treatment during diagnostic imaging, which will facilitate clinical decision-making and patient care."

The FDA clearance is based on the determination of Substantial Equivalence to the INOmax DSIR. The modifications to INOmax DSIR for the INOmax DSIR Plus MRI device included hardware modifications to the cart, an update of the software to include an MRI set-up wizard and modified labeling. The INOmax DSIR Plus MRI has the same intended therapeutic effect and patient population as the previously cleared INOmax DSIRpredicate device.

The INOmax DSIR Plus MRI is considered MR Conditional with the primary targeted use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners ONLY in areas where the field strength is less than 100 gauss. In addition, the INOmax DSIR Plus MRI is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.

Technological Characteristics 

All versions of INOmax DSIR family of delivery systems utilize component technology to deliver INOmax to the patient. The components consist of the Delivery System unit, the INOblender, a stand/cart and INOmax cylinders. In this version of the INOmax DSIR, the cart hardware, the INOmax delivery cable and tubing, the gas sampling tubing, the software, and the labeling have been updated specifically for use in the MRI suite.

"INOmax DSIR Plus MRI was developed with the goal of enhancing patient care and making it easier for physicians to perform an MRI while maintaining their patients on INOMAX therapy," said Steven Romano, MD, Senior Vice President and Chief Scientific Officer, Mallinckrodt Pharmaceuticals.  

The company is committed to making the new device available in November 2015.

ABOUT MALLINCKRODT

Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology; neonatal critical care respiratory therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Global Medical Imaging segment includes contrast media and nuclear imaging agents. .

About INOMAX

INOMAX 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. INOMAX should not be used in the treatment of neonates dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin NO2, and FiO2 should be monitored during nitric oxide administration.

About INOmax DSIR for MRI  

The INOmax DSIR uses a "dual-channel" design to provide delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shut down INOMAX delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

The INOmax DSIR Plus MRI incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DSIR Plus MRI includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. The INOblender can also be used for backup.

Forward-Looking Statements 

Statements in this document that are not strictly historical, including statements regarding the expected timetable for completion of the CMDS divestiture, future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting Mallinckrodt'sbusinesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.

There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the parties' ability to satisfy the conditions to the divestiture of the CMDS business and complete the divestiture on the anticipated timeline or at all; general economic conditions and conditions affecting the industries in which Mallinckrodt operates; the commercial success of Mallinckrodt's products; Mallinckrodt's ability to realize anticipated growth, synergies and cost savings from its recently completed acquisitions; changes in laws and regulations; Mallinckrodt's ability to identify, acquire or close future acquisitions; Mallinckrodt's ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; Mallinckrodt's ability to successfully develop or commercialize new products; Mallinckrodt's ability to protect intellectual property rights; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; limited clinical trial data for H.P. Acthar® Gel; complex reporting and payment obligations under healthcare rebate programs;Mallinckrodt's ability to achieve anticipated benefits of price increases; Mallinckrodt's ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; and the effectiveness of information technology infrastructure.