Prosonix, an innovative specialty pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, announces that its Marketing Authorization Application (MAA) for PSX1001 has been validated and is being assessed under the Decentralized Procedure (DCP), in which the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is the Reference Member State. Prosonix has submitted the primary MAA under the DCP and a simultaneous duplicate MAA on behalf of Mylan Inc.
The MAA submission for PSX1001 leverages the EU regulatory guideline CPMP/EWP/4151/00 Rev. 1 that potentially allows the approval of generic inhaled products on the basis of in vitro only demonstration of therapeutic equivalence of the candidate to the reference product.
The achievement of this milestone has triggered a payment from Mylan under the terms of the licensing agreement for Prosonix’ inhaled respiratory products, PSX1001 and PSX1050, announced in April 2014.
PSX1001 and PSX1050 are the first products to emerge from Prosonix’s innovative and proprietary particle engineering platform, and are being developed as generic versions to GSK’s pressurized metered dose inhalers (pMDI) Flixotide (EU and ROW) and Flovent (U.S.), respectively. Flixotide and Flovent contain the active ingredient fluticasone propionate, a potent inhaled corticosteroid, and are indicated for the treatment of asthma. According to IMS Health, Flixotide and Flovent had global brand sales of approximately $1.3 billion in 2013.
David Hipkiss, CEO and co-founder of Prosonix, said: “The achievement of this key milestone is a landmark event for Prosonix. Our MAA for PSX1001 is the first of our product pipeline to be reviewed under the EU regulatory guidelines that allow the potential approval of generic inhaled products based on in vitro data alone. We are excited to be able to use this regulatory approach to deliver our strategy, consistent with the new Global Initiative for Asthma (GINA) management and prescribing guidelines which we believe are set to dominate the reimbursement and payer agenda for the foreseeable future.”
Under the terms of the global licensing agreement signed by Prosonix and Mylan, Prosonix are responsible for filing PSX1001 in the EU and retain marketing rights in certain territories. Mylan has marketing rights for PSX1001 and PSX1050 in the U.S., Canada, Australia, New Zealand, India, Japan, the EU, Iceland, Liechtenstein, Norway, Switzerland, Turkey, Russian Federation and the Commonwealth of Independent States. All other terms of the agreement remain confidential.
Date: September 2, 2014