STARNBERG, Germany, Nov. 2, 2020 /PRNewswire/ -- PARI Pharma GmbH, a company focused on the development, manufacturing and commercialisation of advanced aerosol delivery systems based on eFlow Technology, announces the issue of the CE declaration of conformity for its optimised eFlow Technology LAMIRA Nebuliser System. It is intended only for use with ARIKAYCE Liposomal 590 mg Nebuliser Dispersion. While PARI issued the CE declaration of conformity in compliance with the Medical Devices Directive (93/42/EEC) for LAMIRA, Insmed was granted the marketing authorisation for ARIKAYCE by the European Commission (EC) on October 28th, 2020.
ARIKAYCE is the first inhaled liposomal dispersion approved by the EC and the first and only therapy in the European Union indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults with limited treatment options who do not have cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents. The LAMIRA Nebuliser System is specifically optimised for the administration of ARIKAYCE, and patented features are included. "LAMIRA is another great example of a nebuliser derived from our eFlow Technology platform and tailored for a specific medicinal product. We leveraged our laser drilled membrane technology and patented aerosol chamber to optimise the delivery of ARIKAYCE's unique liposomal formulation for the benefit of patients with a high need for therapies", said Dr. Stefan Seemann, Vice President eFlow Development and Operations at PARI Pharma.
The LAMIRA Nebuliser System is the sixth drug-specific eFlow Technology device to become commercially available. Since it is used to treat NTM patients LAMIRA extends the range of indications for which optimised eFlow Technology nebulisers are used. "Following the approval of ARIKAYCE and LAMIRA by the US FDA in 2018, we are pleased to expand our partnership with Insmed and to have the opportunity to make the first approved treatment available for these seriously ill patients in Europe", states Dr. Martin Knoch, President of PARI Pharma. Neil Hughes, Head, Europe, Middle East and Africa at Insmed adds: "LAMIRA is integral to delivering ARIKAYCE to appropriate patients with MAC lung disease. We are very pleased about this achievement with our capable and reliable partner PARI."
About MAC Lung Disease
Mycobacterium avium complex (MAC) lung disease is a rare and serious disorder that can significantly increase morbidity and mortality. Patients with MAC lung disease can experience a range of symptoms that often worsen over time, including chronic cough, dyspnoea, fatigue, fever, weight loss, and chest pain. In some cases, MAC lung disease can cause severe, even permanent damage to the lungs, and can be fatal. MAC lung disease is an emerging public health concern worldwide with significant unmet needs.
About PARI Pharma GmbH and eFlow Technology
PARI is a world leader in the development of aerosol delivery devices. PARI Pharma develops, commercialises, and manufactures optimised eFlow Technology nebulisers in cooperation with partners from the pharmaceutical industry and contributes to advanced drug-device combination products that bring relief for patients with serious lung diseases.
eFlow Technology is an aerosol delivery platform that enables efficient nebulisation of liquid medications via a vibrating, perforated membrane. eFlow Technology devices are designed to significantly improve upper and lower respiratory tract deposition and reduce the burden of treatment for patients with severe respiratory conditions.
PARI Pharma is located near Munich, Germany, with a major presence in the United States. For more information, please visit www.pari.com/eFlow-partnering.
ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension) and in the EU as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion. Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the LAMIRA Nebuliser System manufactured by PARI Pharma GmbH (PARI).
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases.
ARIKAYCE® is a registered trademark of Insmed Incorporated.
LAMIRA® is a registered trademark of PARI Pharma GmbH.
eFlow® is a registered trademark of PARI Pharma GmbH.
Director eFlow Partnering & Strategy
SOURCE PARI Pharma