Futura Medical Regulatory News (FUM)

8 Sep 2009 07:00



Futura Medical plc

Update on CSD500

Futura Medical plc (AIM: FUM), the pharmaceutical group that develops innovative products for consumer healthcare, is pleased to announce that CSD500, its lead product to be launched as a Durex®-branded condom by SSL International plc (SSL), is on track to receive the CE Mark following the transfer of manufacturing by SSL to facilities in India.

Futura and SSL had initially provided the relevant Notified Body and Competent Authority - the regulatory bodies overseeing the award of the CE Mark - with technical data relating to the manufacture of CSD500 in Spain. Following the move of manufacturing to India it is a normal regulatory requirement to undertake validation runs at the new location. The validation runs have now been undertaken and data on manufactured product is being generated according to a pre-defined schedule to demonstrate compliance with specification and thereby to satisfy the remaining regulatory requirements.

Discussions are now underway with the relevant Notified Body to agree the schedule for the granting of the CE Mark, the European marketing authorisation for the product.

The timing of the grant of the CE Mark for CSD500 remains in line with earlier estimates of around the end of the current calendar year with commercial launch by SSL thereafter.

James Barder, Futura's Chief Executive, said: "I am pleased by the progress that has been made following the enormous effort put in by the technical teams to complete this transfer as quickly as possible and move to commercialisation."

For further information please contact:

www.futuramedical.co.uk