PharmAust (ASX:PAA) has been granted small and medium- sized enterprise (SME) status by the European Medicines Agency (EMA).
This status entitles the company to receive regulatory fee incentives and additional support from the EMA, streamlining regulatory engagement and the ability to advance it monepantel candidate for the treatment of motor neurone disease (MND)/ Amyotrophic Lateral Sclerosis (ALS).
The SME status provides eligible companies with a range of financial benefits, including reductions in fees for scientific advice, inspections, and pre- and post-marketing authorisation applications. It is available to eligible enterprises with fewer than 250 employees and not more than €50 million in revenue.
“We are proud to receive SME status from the EMA. This signals the beginning of a productive partnership with the key drug regulator in Europe and an important step towards accelerating start-up activities for our adaptive Phase 2/3 Strike study,” Managing Director, Dr Michael Thurn, said.
“The incidence of MND/ALS in European countries are amongst the highest globally, ranging from 1.5 to 3.8 per 100,000 people.1 Incredibly, there is only one drug, riluzole, approved for the treatment of all types of MND/ALS in Europe which only offers patients an additional two to three months in life expectancy.
“The SME status from the EMA provides continued momentum in our efforts to help patients and their families impacted by MND/ALS.”
