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Thursday, December 7, 2017

Magnair™ an eFlow® Closed System Nebulizer together with Sunovion’s Lonhala™ is the first eFlow Technology based product to receive FDA Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)


LONHALA MAGNAIR Inhalation Solution is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the U.S.


Starnberg, Germany, December 6, 2017 – PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow® Technology announces approval of its first eFlow closed system nebulizer Magnair™ together with Sunovion’s Lonhala™ (glycopyrrolate) Inhalation Solution. The drug/device combination product received FDA approval on December 5, 2017 under a New Drug Application (NDA).

MAGNAIR, designed, optimized, and developed by PARI Pharma, is intended for use with LONHALA (glycopyrrolate) Inhalation Solution vials in patients with COPD only. MAGNAIR is the first product to be commercialized using PARI Pharma’s innovative eFlow closed system nebulizer technology, which does not have a traditional open medication reservoir into which patients manually transfer the liquid drug product from a vial. MAGNAIR features a proprietary blow-fill-seal ampoule which is inserted into the cap of the MAGNAIR and pierced open once the cap of the MAGNAIR handset is closed, without the need for a manual filling step. This feature is designed to reduce the risk of spilling the medication when the vial is emptied. As with all eFlow Technology nebulizers, MAGNAIR allows the patient to breathe naturally without any special breathing technique. The patient inhales and exhales as they normally do at rest.

“So far, eFlow Technology nebulizers like Altera®, Zirela®, Tolero® or eRapid®/eFlow®rapid are available to patients suffering from the orphan indication of cystic fibrosis. With the approval of LONHALA MAGNAIR for COPD, we are bringing a new advancement in nebulizers to people with COPD that are designed to be efficient, silent and fast. It is great to see our technology addressing an unmet medical need for a nebulized LAMA,” states Dr. Martin Knoch, President of PARI Pharma. “MAGNAIR is a great example of the flexibility of development and optimization using the eFlow Technology platform,” added Geoff Hunziker, President of PARI Pharma’s US sister company eFlow LLC.

“Sunovion is pleased that the FDA has approved LONHALA MAGNAIR as the first nebulized long-acting muscarinic antagonist treatment option for people in the U.S. living with COPD,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. “We believe that LONHALA MAGNAIR is an important advancement for patients who may prefer nebulized medications and a therapy that fits into their everyday lives.”

About PARI Pharma and eFlow® Technology

PARI Pharma is a world leader in the development of aerosol delivery devices optimized with drug products for nebulized treatments using its proprietary technologies and expertise. PARI’s platform of nebulizer systems based on eFlow Technology incorporate 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, a PARI Medical Holding company, is located near Munich, Germany and has a major presence in the United States. For additional information, please visit www.paripharma.com.

About LONHALA MAGNAIR

LONHALA MAGNAIR (glycopyrrolate) Inhalation Solution, previously known as SUN-101/eFlow®, is the first long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the innovative, proprietary MAGNAIR closed system nebulizer based on eFlow® Technology. The MAGNAIR nebulizer system is designed to deliver the drug in two to three minutes and allows patients to breathe normally while using the device. LONHALA MAGNAIR is approved for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.


LONHALA is a trademark of Sunovion Pharmaceuticals Inc.
MAGNAIR is a trademark of PARI Pharma GmbH.
eFlow® is a registered trademark of PARI Pharma GmbH.

Contact: Michael Hahn
Director eFlow Partnering
PARI Pharma GmbH
+49 (0) 89 74 28 46 -831
michael.hahnpari.com

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