ASX Announcement – Green Whistle receives regulatory approval in South Africa
Medical Developments International Limited (ASX:MVP) has received approval from the Medicines Control Council (MCC) in South Africa to market and sell its inhaled analgesic product, ‘Penthrox’ for pain relief from trauma and surgical procedures.
The approval gives MVP’s partner in South Africa, LINK Healthcare Pte Ltd (through its wholly owned subsidiary Equity Pharmaceuticals Pty Ltd), the right to start selling ‘Penthrox’ (marketed as ‘Penthrop’ in South Africa) effective immediately. LINK Healthcare estimates the size of the prescription only analgesic market in South Africa is $90 million.
The approval in South Africa opens the regulatory pathway for approvals to sell Penthrox in Namibia, Botswana, Lesotho, Swaziland, Angola, Malawi, Mozambique and Zambia. LINK Healthcare advise the approval process in these countries will take less than 12 months because South African regulators have registered Penthrox for sale. MVP CEO, Mr. John Sharman said “this approval is a great opportunity for our company and could open the door to Africa’.
Mr. Sharman said ‘this registration is the first indication we have received that the work done on our clinical trials in England for our regulatory dossier in that country, will enable our company to get approval to sell Penthrox in countries other than the EU where we are currently being assessed. MVP is in discussion with pharmaceutical companies in various countries in Europe and elsewhere and we are hopeful we can conclude a number of licensing and distribution agreements in the coming months.”