ABINGDON, England, Dec. 21, 2018
ABINGDON, England, Dec. 21, 2018 /PRNewswire/ -- NPXe limited and Linde jointly announced the enrollment of the first EU patient in a pivotal Phase III trial of Xenon gas in Post-Cardiac Arrest Syndrome. (Xenon gas for inhalation is an investigational drug, the safety and efficacy of which has not yet been established.)
The Phase III trial will include approximately seventy sites, roughly fifty in in Europe. Denmark is the first EU country to begin enrolling. The companies plan to extend the trial to Germany, France, the United Kingdom, Spain, Austria, and Poland in the coming months as local ethics committee guidelines are met.
Dr. Christian Hassager, Professor of Cardiology at the University of Copenhagen, the first enrolling site, commented on the trial, "Patients with PCAS have so few options. Presently, the standard of care is cooling. If Phase III data matches Phase II data in the target population, this would be a major advance in patient care."
Urmi Richardson, Global Head of Healthcare, at Linde elaborated, "We are excited to see this key milestone being delivered, showing that we are on track to being able to bring this pioneering therapy into the European market."
The U.S. Food and Drug Administration (FDA) approved a Special Protocol Assessment1 for the trial and the drug has been granted its Fast Track designation2. The company expects the regulatory submission to be a drug and delivery device combination and are working towards and anticipated U.S. regulatory approval and launch in late 2020.
Learn more about the U.S. trial on clinicaltrials.gov here.
1.The Special Protocol Assessment allows for an interim analysis at 50% of trial completion of the primary endpoint follow up, and if the primary and secondary endpoints are positive at that review the trial would be halted for success. If the primary or secondary endpoints are futile at that point, the trial will be stopped for futility.
2.The Fast Track designation is provided to drug candidates that "treat a serious condition and fill an unmet medical need." The key benefits to recipients of a Fast Track designation include more frequent contact with the FDA on the development program and the option of Rolling Review, which allows a company to submit completed sections of the New Drug Application (NDA) for individual review by the Agency. This compares with the normal process where the entire NDA must be completed before submission. The frequency of communication under the Rolling Review better assures that questions and issues are resolved quickly, potentially leading to earlier drug approval and patient access.
About Xenon Gas for Inhalation in Post-Cardiac Arrest Syndrome (''PCAS'')
Xenon is a noble gas that has been used as an inhaled therapy in several studies to date. In PCAS, more N-methyl-D-aspartate receptors ("NMDAR", a calcium channel found in neurons) are overactivated, causing extreme ion imbalances, neuronal damage and cell death. Studies have shown that xenon may help to inhibit the NMDAR through a unique inhibition at the glycine-binding site and can help moderate the flow of damaging ions through the calcium channel. By mitigating neuronal damage and cell death, xenon may be able to improve functional outcomes and reduce mortality rates in survivors. The FDA has not yet established the safety and effectiveness of xenon gas for inhalation for PCAS.
NPXe is developing xenon gas for inhalation for the treatment of Post-Cardiac Arrest Syndrome. The Company has a Special Protocol Agreement with the FDA and A Scientific Working Party Agreement with the European Medicines Agency (EMA). Both the FDA and EMA have provided the sought PCAS indication with Orphan Drug status. Orphan status prolongs the period of market exclusivity post approval. The FDA has also granted the drug Fast Track designation. Linde has licensed the rights to market xenon gas for inhalation in the EU, United Kingdom, Norway, Switzerland and Iceland are licensed to a third party. A third party has licensed the rights to market xenon gas for inhalation in North America, Australia and Japan upon approval in each country.
About Linde Healthcare
Linde Healthcare is a global leader specializing along an integrated respiratory care path. It combines pharmaceutical gases, medical devices, services and clinical care into solutions with the patient in mind. Its products and services make a difference in the lives of its patients and to its healthcare partners in the care continuum from hospital to home. A global business unit of The Linde Group, it is present in over 60 countries and generated revenues of EUR 3.361bn in 2017.
For more information, visit Linde Healthcare online at www.linde-healthcare.com
About The Linde Group
In the 2017 financial year, The Linde Group generated revenue of EUR 17.113 bn, making it one of the leading gases and engineering companies in the world, with approximately 58,000 employees working in more than 100 countries worldwide. The strategy of The Linde Group is geared towards long-term profitable growth and focuses on the expansion of its international business, with forward-looking products and services. Linde acts responsibly towards its shareholders, business partners, employees, society and the environment in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.
For more information, see The Linde Group online at www.linde.com
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning xenon gas for inhalation including expectations with regard to clinical trials, future regulatory actions and potential impact on patients. 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; future commercialization efforts; 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.
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