LAMIRA®, an eFlow® Technology nebulizer, expected to launch in Japan as a medical device for exclusive administration of ARIKAYCE® (amikacin liposome inhalation suspension)

2021-03-24 08:12:23

(MENAFN- PR Newswire) STARNBERG, Germany, March 24, 2021 /PRNewswire/ -- PARI Pharma GmbH, a company focused on advanced aerosol delivery systems based on eFlow Technology, announces the authorization of the LAMIRA Nebulizer System for delivery of Insmed's drug product ARIKAYCE (amikacin liposome inhalation suspension) in Japan. Insmed was granted approval for ARIKAYCE by Japan's Ministry of Health, Labour and Welfare (MHLW) on March 23rd, 2021. The approval of ARIKAYCE in Japan follows earlier approvals in the United States and Europe. LAMIRA is the first drug-specific eFlow Technology nebulizer registered beyond Europe and North America.

eFlow Partnering eBase Controller with Lamira Handset

The LAMIRA Nebulizer System is specifically optimized for ARIKAYCE and therefore the only device intended to administer it. Key features of LAMIRA include a customized medication reservoir to hold a full 8.4 ml dose, a specifically tailored aerosol head for the aerosolization of ARIKAYCE and the valved aerosol chamber.

ARIKAYCE is the first inhaled liposomal dispersion approved by the MHLW and the first and only therapy in Japan indicated for the treatment of patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who did not sufficiently respond to prior treatment with a multidrug regimen.

"LAMIRA enables us the ability to offer an eFlow Technology nebulizer to patients beyond Europe and North America. We are delighted that appropriate patients in Japan suffering from NTM lung disease now have access to a new treatment option," said Dr. Martin Knoch, President at PARI Pharma.

Yuji Orihara, General Manager, Japan, for Insmed adds: "We are pleased that our valuable partnership with PARI has enabled us to bring to market the first approved drug, ARIKAYCE, to be used with the LAMIRA Nebulizer Device specifically for the treatment of patients in Japan with refractory MAC lung disease."

About PARI Pharma GmbH and eFlow Technology

PARI is a world leader in the development of aerosol delivery devices. PARI Pharma focuses on pharma licensing partnerships that utilize eFlow Technology nebulizers optimized to specific drug products and formulations.

eFlow Technology is an aerosol delivery platform that enables efficient nebulization of liquid medications via a vibrating, perforated membrane. eFlow Technology devices are designed to reduce the burden of treatment for patients with severe respiratory conditions.

About ARIKAYCE

ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in the EU as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE® Inhalation 590 mg (amikacin sulfate inhalation drug product). ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs. ARIKAYCE is administered once daily using exclusively the LAMIRA Nebulizer System.

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.

Contact: Michael Hahn Vice President eFlow Partnering & Strategy PARI Pharma GmbH [email protected]

SOURCE PARI Pharma