Mallinckrodt's INOmax® Approved In Australia And Japan For Pulmonary Hypertension In Conjunction With Heart Surgery
- Approved indication in Australia expanded to include use of INOmax for peri- and post-operative pulmonary hypertension in conjunction with cardiovascular surgery in infants and children up to age 17
- Approved indication in Japan expanded to include use of INOmax for peri-operative hypertension in conjunction with cardiovascular surgery in neonates through adults
CHESTERFIELD, United Kingdom, Oct. 30, 2015 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that INOmax® (nitric oxide) for inhalation has received regulatory approval in Australia and Japan for pulmonary hypertension in conjunction with heart surgery. INOmax was the first pharmaceutical gas approved in both Australia and Japan in 2007 and 2008, respectively, for the treatment of hypoxic respiratory failure (HRF), a potentially life-threatening condition in newborns. INOmax is approved in the United States 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 is not approved in the United States for use in patients older than neonates, and is not approved by the FDA for use in the surgical setting.
Details of the new approvals follow:
- The Australian Therapeutic Goods Administration (TGA) has approved INOmax® for peri- and post-operative pulmonary hypertension in conjunction with cardiovascular surgery in neonates through adolescents up to age 17. INOmax was approved in 2007 for the treatment of hypoxic respiratory failure (HRF) associated with pulmonary hypertension, a potentially life-threatening condition in newborns.
- Japan's Ministry of Health, Labour and Welfare (MHLW) has approved INOmax, marketed as INOflo/INOvent® in Japan, for peri-operative pulmonary hypertension in conjunction with cardiovascular surgery for use in neonates through adults.
INOmax is a vasodilator that opens (dilates) blood vessels, improving oxygen uptake and blood flow. It is used in conjunction with ventilator support and other appropriate agents. INOmax decreases pulmonary arterial pressure and improves oxygenation.
In newborns with HRF associated with concurrent pulmonary hypertension, INOmax has been shown to improve oxygenation and reduce the need for a highly invasive surgical procedure known as extracorporeal membrane oxygenation (ECMO). The new indications in Japan and Australia expand INOmax's use to broader patient populations.
"The approval of INOmax in Australia and Japan for cardiovascular surgery represents a significant milestone for Mallinckrodt and INOmax," said Tom Englese, General Manager, Mallinckrodt. "Worldwide, there is a tremendous need for therapies for patients undergoing cardiac surgery. We look forward to helping meet these needs while broadening our reach in global markets."
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 for prescribing by office- and hospital-based physicians. 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. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
In the U.S., INOmax is approved for use by the U.S. Food and Drug Administration (FDA), 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 even in neonates with no apparent response to nitric oxide for inhalation.
- 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, methemoglobin, and inspired NO2 during INOMAX administration.
- Use only with an INOmax DSIR®, operated by trained personnel.
Please see full Prescribing Information here for additional important safety information.
Add Cautionary Statements Related to 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's businesses 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.
These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended September 26, 2014 and Quarterly Reports on Form 10-Q for the quarters ended March 27, 2015 and June 26, 2015. 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.
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