Mundipharma AG Release: Green Whistle Receives Regulatorry And Marketing Approval In The United Kingdom
Medical Developments International Limited (ASX:MVP) is delighted to announce that it has received
final approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to market and
sell its inhaled analgesic product, ‘Penthrox’ indicated for trauma and associated pain, in the United
Kingdom.
This approval gives MVP’s partner in the United Kingdom, Galen Ltd the opportunity to sell Penthrox effective immediately. Galen is planning to launch Penthrox at a major Intensive Care Conference in London during December. Therefore MVP expects first sales to be in January 2016.
Under Galen’s Distribution, Licensing and Supply agreement with MVP, the MHRA approval means Galen will pay MVP another milestone payment of GBP £450k. MVP will receive this in 1H FY16.
MVP CEO, Mr. John Sharman said “This final approval from the MHRA is a defining moment for the company. Our partner Galen Ltd has already submitted its forecast orders for the UK and Irish markets which we are beginning to manufacture in preparation for delivery in January. We expect significant sales to be made in 2H FY16 and beyond.”
Mr. Sharman said “The MHRA approval overnight is also the trigger for final approval in France and Ireland. We already have approval in Belgium. Importantly, Mundipharma has also submitted its forecast orders for France and Belgium, which are significant. We expect sales to commence in France and Belgium during H2FY16 once approval in France is granted. Mundipharma is responsible for other European country approvals such as Germany, Italy and Spain which they are working on and we expect many of these to be achieved during FY17.
Once approval from France is receipted Mundipharma will pay MVP a further milestone payment of USD $3m.
Enquiries:
David Williams John Sharman
Chairman Chief Executive Officer
Medical Developments International Ltd Medical Developments International Ltd
0414383593 03 9547 1888
About Penthrox
Penthrox is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. Penthrox has been used safely and effectively for more than 30 years in Australia with excess of 5.0 million units sold. There is growing interest in Penthrox being used in patients undergoing investigatory procedures, as well as operational procedures such as colonoscopy.
About Medical Developments International Ltd
MVP is an Australian company delivering emergency medical solutions dedicated to improving patient outcomes. MVP is a leader in emergency pain relief and respiratory products. The Company manufactures Penthrox®, a fast acting trauma & emergency pain relief product. It is used in Australian Hospitals including Emergency Departments, Australian Ambulance Services, the Australian Defence Forces, Sports Medicine and for analgesia during short surgical procedures such as Dental and Cosmetic surgery as well as in other medical applications. MVP is expanding internationally and manufactures a range of world-leading Asthma respiratory devices.
About Galen
Galen is a leading UK specialty pharmaceutical sales and marketing company, and has a significant presence in the UK and Irish markets. Galen is part of the Almac group which has in excess of 3,000 employees worldwide and is headquartered in Northern Ireland. Galen’s knowledge of the target markets in the UK and Ireland will allow it to establish Penthrox as the leading product in selfadministered trauma pain relief in the hospital and pre hospital environments.
About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. The Mundipharma network has a presence in 51 countries with more than 7800 employees across the world. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain management, oncology, respiratory and inflammatory conditions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.
For further information please visit: www.mundipharma.com
Help employers find you! Check out all the jobs and post your resume.
This approval gives MVP’s partner in the United Kingdom, Galen Ltd the opportunity to sell Penthrox effective immediately. Galen is planning to launch Penthrox at a major Intensive Care Conference in London during December. Therefore MVP expects first sales to be in January 2016.
Under Galen’s Distribution, Licensing and Supply agreement with MVP, the MHRA approval means Galen will pay MVP another milestone payment of GBP £450k. MVP will receive this in 1H FY16.
MVP CEO, Mr. John Sharman said “This final approval from the MHRA is a defining moment for the company. Our partner Galen Ltd has already submitted its forecast orders for the UK and Irish markets which we are beginning to manufacture in preparation for delivery in January. We expect significant sales to be made in 2H FY16 and beyond.”
Mr. Sharman said “The MHRA approval overnight is also the trigger for final approval in France and Ireland. We already have approval in Belgium. Importantly, Mundipharma has also submitted its forecast orders for France and Belgium, which are significant. We expect sales to commence in France and Belgium during H2FY16 once approval in France is granted. Mundipharma is responsible for other European country approvals such as Germany, Italy and Spain which they are working on and we expect many of these to be achieved during FY17.
Once approval from France is receipted Mundipharma will pay MVP a further milestone payment of USD $3m.
Enquiries:
David Williams John Sharman
Chairman Chief Executive Officer
Medical Developments International Ltd Medical Developments International Ltd
0414383593 03 9547 1888
About Penthrox
Penthrox is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. Penthrox has been used safely and effectively for more than 30 years in Australia with excess of 5.0 million units sold. There is growing interest in Penthrox being used in patients undergoing investigatory procedures, as well as operational procedures such as colonoscopy.
About Medical Developments International Ltd
MVP is an Australian company delivering emergency medical solutions dedicated to improving patient outcomes. MVP is a leader in emergency pain relief and respiratory products. The Company manufactures Penthrox®, a fast acting trauma & emergency pain relief product. It is used in Australian Hospitals including Emergency Departments, Australian Ambulance Services, the Australian Defence Forces, Sports Medicine and for analgesia during short surgical procedures such as Dental and Cosmetic surgery as well as in other medical applications. MVP is expanding internationally and manufactures a range of world-leading Asthma respiratory devices.
About Galen
Galen is a leading UK specialty pharmaceutical sales and marketing company, and has a significant presence in the UK and Irish markets. Galen is part of the Almac group which has in excess of 3,000 employees worldwide and is headquartered in Northern Ireland. Galen’s knowledge of the target markets in the UK and Ireland will allow it to establish Penthrox as the leading product in selfadministered trauma pain relief in the hospital and pre hospital environments.
About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. The Mundipharma network has a presence in 51 countries with more than 7800 employees across the world. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain management, oncology, respiratory and inflammatory conditions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.
For further information please visit: www.mundipharma.com
Help employers find you! Check out all the jobs and post your resume.