Extends Shelf Life of CSD500
16 December 2015
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, announces that it has achieved a significantly extended shelf for its novel condom CSD500 compared with the currently approved shelf life of one year. The extended shelf life has been achieved using a modified manufacturing process as outlined in the Company's half yearly report announced on 9 September 2015 with testing conducted in accordance with ISO 4074 and GMP/ICH guidelines.
Futura expects the new shelf life to meet the launch requirements of CSD500's existing commercial partners. The new shelf life is significantly longer than the one year previously approved, though it is the role of the regulator to approve the duration of the new shelf life. A regulatory submission will be made shortly.
CSD500 received regulatory approval in Europe in 2011 and much of the new filing will replicate the earlier approval process. The Company is working with CSD500's commercial partners on timetables for the launch of the product, which has been out-licensed on a territorial basis to cover a current total of 31 countries.
James Barder, Futura's Chief Executive, commented: "We continue to be reassured by monthly stability data reports achieved for CSD500 on both ambient and heated temperatures in compliance of industry standards. We are now sufficiently confident to seek regulatory approval on the modified manufacturing process in order to provide an extended shelf life product. Data continues to compare very positively with our earlier approved product and we expect the extended shelf life product to meet the launch requirements of our commercial partners."
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Notes to editors:
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.