Kidney injuries affect 12 million people each year
  • ROSgard™ is the first recombinant drug based on A1M
  • Trials show protective and healing effects in damaged kidneys
  • Platform technology with plenty of potential applications
Quicker route to market
  • ROSgard has broad patent protection
  • Manufacture of ROSgard for preclinical trials was completed in 2017, with a safety study in healthy volunteers commencing in 2018
  • Proof of Concept for PRRT is creating value more rapidly than previously planned – supports future clinical trials for pre-eclampsia, a serious illness that affects 10 million women each year
Reduced risks, increased value
  • Improved scope for partnerships
  • Exit through increase in share value or in the event of a sale
  • The price per new share – generous discount in relation to the value of conducted research and ROSgard’s market potential
Significant market potential
The market for kidney protection in connection with treatment of neuroendocrine tumours – PRRT – is estimated to be worth approx. USD 200–500 million. Good results within kidney protection in connection with PRRT also enable broader use of ROSgard within radiation therapy – a market that is worth USD 8 billion.

The estimated sale of ROSgard for treatment of pre-eclampsia is calculated to be in excess of USD 1.2 billion by year 5.

ROSgard – orphan drug designation within treatment of pre-eclampsia
In July 2014 A1M Pharma was granted formal approval by the European Commission for orphan drug designation in Europe for the company’s pre-eclampsia treatment. The company has formal approval from the European Commission for orphan drug designation in Europe for the company’s pre-eclampsia treatment. This means that the product can have market exclusivity after marketing authorisation even if current patents are no longer valid. Orphan drug designation provides exclusivity for up to ten years within the EU from the date of marketing authorisation. In addition, A1M Pharma will receive free consultation, scientific advice and reduced costs for regulatory applications for commercialisation, providing immense advantages in ongoing work.

As regards orphan drug designation for ROSgard in connection with PRRT, the possibilities for this are being examined in both the EU and the USA.
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