Futura Medical plc and Reckitt Benckiser have agreed to terminate a commercial partnership focused on the continued development and commercialisation of the CSD500 condom. Going forward, Futura intends to partner CSD500 with an alternative condom manufacturer or healthcare company. Futura has also regained worldwide ownership of MED2002, a topical gel for the treatment of erectile dysfunction, which was also licensed to Reckitt Benckiser.
In order to get CSD500 to market as quickly as possible, Futura will take control of the manufacturing of the product and apply directly for a CE mark. Manufacturing will be outsourced to a third party manufacturer for onward supply of finished condoms to commercial partners. To this end, development work with an independent contract condom manufacturer has already commenced. The manufacturer already has the necessary ISO certification for the manufacture of condoms with ancillary medicinal substances.
Futura has ownership rights over all previous clinical data generated for the original approved dossier and therefore does not anticipate the need for any new clinical data. The company expects to submit a new CE mark dossier in the first half of 2013 to the regulatory authorities that approved CSD500 in 2011.