ASX Announcement – Green Whistle: Positive ‘Regulatory Approval’ feedback from European Regulatory Authorities
Medical Developments International Limited (ASX:MVP) is delighted to announce that it has received positive feedback from the Medicine and Healthcare products Regulatory Agency (‘MHRA’) to market and sell its inhaled analgesic product, ‘Penthrox’ in the United Kingdom, and by extension to France, Belgium and Ireland via the Decentralised Procedure.
The MHRA has also outlined the timeframe for formal approval of Penthrox in these markets, which is expected to be completed within 90 days.
The MHRA states that based on its review of the data on quality, safety and efficacy of Penthrox, it ‘considers that the application for Penthrox in the treatment of pain relief by self-administration to conscious patients with trauma and associated pain is approvable provided that some listed outstanding points are satisfactorily addressed’.
The outstanding points are a combination of labelling, training, administrative, quality, clinical and non-clinical matters which are already being addressed. MVP is confident it can address all the points in the coming weeks.
As a result of the pending Regulatory Approval, we estimate Galen Pharmaceuticals Ltd., MVP’s partner in the United Kingdom, may have the opportunity to sell ‘Penthrox’ into markets in the United Kingdom and Ireland in about April or May 2015. Plans for the Penthrox launch in these markets are already well underway.
MVP CEO, Mr. Sharman said, “The approval of Penthrox for use in the United Kingdom, France, Belgium and Ireland will be a company-making achievement for us. It opens up these European markets to Penthrox for the first time and more importantly, pursuant to the ‘Mutual Recognition’ process for further regulatory approvals for other countries within the European Union.”
MVP Chairman, Mr. David Williams noted, ‘We are very proud of our achievements so far in Europe. Penthrox is a remarkable drug and it will be fantastic to see Australia’s first choice, front line analgesic used by foreign doctors, hospitals and ambulance. Our drug helps trauma patients relieve their pain quickly and also makes minor surgical procedures more comfortable. This pending regulatory approval in the United Kingdom, France, Belgium and Ireland is the first step in our globalization strategy for Penthrox, which is well underway.’
Mr. Sharman said, “The ‘Regulatory Dossier’ used for the European Marketing Authorisation Application has been submitted to other regulatory agencies around the world with the purpose of getting Penthrox approved for sale in other markets. Included in the Regulatory Dossier is a range of clinical studies which have been conducted in the United Kingdom, Australia and elsewhere and which evidence and support the clinical efficacy and safety of Penthrox”.
Mr. Sharman said, “We are in discussion with a number of business partners in various countries in Europe and elsewhere and we are hopeful we can agree terms and conclude negotiations in the coming months. Approval in Europe will facilitate ongoing partnership and licensing discussions and we are confident it will directly assist in obtaining regulatory approvals in other countries around the world.”
|David Williams||John Sharman|
|Chairman||Chief Executive Officer|
|Medical Developments International Ltd||Medical Developments International Ltd|
|0414 383 593||(03) 9547 1888|