ASX Announcement: Overseas Registration and Partnership Update
Update on European Marketing Application
In November 2013, Medical Developments International (MVP) submitted its regulatory dossier and Marketing Authorisation Application for review to ‘The Medicines and Healthcare Products Regulatory Agency’ (“MHRA”) in England. On 27 January, 2014 MVP received its first round of questions from the MHRA. We have completed our responses and we are satisfied we have responded well to all the questions raised by the MHRA. We have agreed with the MHRA to submit our draft responses for their review and expect to do that in the next week. We expect the MHRA review process to be complete within six months. If successful, Penthrox® will initially be approved for sale in the United Kingdom, France, Belgium and Ireland before the end of the 2014 calendar year.
European Marketing Partners and other markets
In August 2013, we commenced our search for suitable business partners for the distribution of Penthrox in Europe in anticipation of a favorable registration outcome. We have also searched other markets for distributors. We recently signed binding terms sheets and final documentation with companies in Mexico and Singapore and we have unsigned offers from companies wanting to represent us in the UK, France, Belgium, Ireland, Spain and Hungary. We are negotiating with companies to cover these markets and we expect to announce some deals in the coming months. Some of these agreements will have upfront licence payments to MVP.
As part of our globalisation strategy for Penthrox, we are also discussing distribution partnerships with companies representing Israel, Taiwan and Canadian markets.
Penthrox Business in Australia
We are in discussions with several large companies to distribute Penthrox to general practitioners and hospitals in Australia and we expect to announce a deal in the near future.