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news.Mundipharma International and Medical Developments International have formed an alliance to commercialize Penthrox (low dose methoxyflurane) in Europe, as a self-inhaled analgesic to treat emergency pain.
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The companies have signed a license, development and commercialization agreement, under which Mundipharma will have exclusive product rights in 39 European markets including France, Germany, Italy and Spain.
The company will not have rights in Hungary, Republic of Ireland and the UK. Mundipharma will pay Medical Developments upfront and milestone payments of about $54.5m.
Medical Developments will also receive a gross margin on product sold to Mundipharma and royalties depending on net sales.
First country launches are expected to start next year after registration and local pricing and reimbursement approvals.
Mundipharma International head of pain Kate Hurtig said: "With this alliance we are excited to expand our portfolio into the field of emergency pain relief and we look forward to quickly advancing the European development and commercialisation of Penthrox to maximise its success."
Penthrox is a non-narcotic self-inhaled analgesic for the emergency relief of moderate to severe pain related with trauma and associated pain.
It is currently registered and marketed in 10 countries globally, including Australia, South Africa and New Zealand.
Medical Developments is in the process of submitting applications for Penthrox to regulatory agencies in Hong Kong, Iran, Israel, Malaysia, Mexico, Russia, Saudi Arabia, Singapore and Taiwan.
The company said due to the potential nephrotoxic effects methoxyflurane must not be used as an anaesthetic agent as the risk is associated to the total dose and frequent exposure. It impairs renal function in a dose-related manner.