ATL1103 for acromegaly granted orphan status in Europe

Company News

Antisense Therapeutics (ASX:ANP) has announced that the European Commission has granted orphan medicinal product designation for ATL1103 for the treatment of Acromegaly in the European Union (EU).

The approval was based on the recommendation of a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

The COMP assessed the scientific documentation for ATL1103 against the criteria for orphan designation, stating in their opinion the therapy ”….will be of significant benefit to those affected by that condition”.

Orphan designation in the EU enables sponsors to benefit from a number of incentives, including ten years of market exclusivity once the medicine is on the market. During that exclusivity period, the EMA and the EU Member states shall not accept another application for a marketing authorisation for the same therapeutic indication in respect of a similar medicinal product.

Other benefits relate to assistance in developing clinical protocols, reduced fees, and access to the EU-funded research grants. ATL1103 for acromegaly was recently granted orphan drug designation by the US FDA, which provides incentives including seven years of market exclusivity in that country.

Mark Diamond, the company's managing director and CEO, said: “This European Orphan designation is another major step forward in the development of ATL1103. The assistance from the EMA in the development of ATL1103 will be invaluable in helping to bring this product to acromegaly patients and will confirm to our potential development partners that the benefits associated with the orphan pathway will be applicable in any transaction.”