PH constitutes a significant disease burden both for patients by dramatically reducing life expectancy and quality, as well as for payers and society, through high costs for the healthcare system. There is no approved treatment for PH; thus, there is a clear unmet medical need to develop novel treatment options for this life-threatening disease for adults and children.
This is a rare orphan disease, the prevalence of PH is around 5 per 1 million (at least 3,000 patients in EEA and the US) with higher prevalence in the Middle East and North Africa. PH represents a significant unmet need and is a high value market opportunity.
We target this global need for a safe, effective drug for PH patients to prevent disease progression and end-organ damage. Oxabact was granted Orphan Drug Designation for treatment of PH by the European Medicines Agency and the US Food and Drugs Administration in 2006.
The selection of a genetic disease (PH) is ideal to develop proof of concept and a first to clinic product for our new class of pharmaceuticals. That said, we believe there are other diseases or indications that would benefit from Oxabact treatment. OxThera holds Orphan Drug Designation for Oxabact® for the treatment of Short Bowel Syndrome in Europe.
OxThera has built a substantial patent portfolio around its approach. As of today, more than 100 patent applications have been filed of which more than 70 have been granted already. The IP portfolio covers all major markets and has expiry dates between 2018 and 2036.