EMEA grants orphan drug status to Active Biotech and Astion Pharma products

Active Biotech and Astion Pharma have announced that ANYARA and ASF-1096, respectively, have been granted Orphan Drug Status by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA).

Orphan drug designation is designed to promote the development of drugs which may provide significant benefits to patients suffering from rare diseases. It provides a variety of incentives, including market exclusitivity for up to 10 years following approval and a reduce of costs and use of time. Thus, the orphan drug designation for ANYARA and ASF-1096 is an important step for both Active Biotech and Astion Pharma.

Important benefits for Active Biotech 

ANYARA is one of Active Biotech's lead oncology candidate drugs and is currently in clinical phase II/III trials for the indication Renal Cancer.

- EMEA's decision to grant orphan drug status for the treatment of patients with Renal Cancer is an important step in the development of ANYARA, says Sven Andréasson, CEO of Active Biotech.

- It provides us with important benefits, both in preparation for a marketing application and also commercially in the form of potential market exclusivity.

Optimal development for Astion Pharma's ASF-1096

ASF-1096, which is a R-enantiomer of salbutamol formulated as a cream for topical treatment of cutaneous lupus, holds promising therapeutic potential in cutaneous lupus treatment (DLE).

The development of ASF-1096 is currently in phase II, but Astion Pharma expects to initiate phase III development within 6 to 12 months.

- The orphan drug status is a step in the right direction. It brings ASF-1096 in an optimal development in order to reach the market, says managing director Lars Smedegaard Andersen.

For further information visit the Active Biotech homepage and the Astion Pharma homepage.

Sources: Active Biotech, press release, 26.07.2007 & Astion Pharma, press release, 01.08.2007