CSD500: Approval of TTK with Extended Shelf Life
27 October 2016
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that, as anticipated, its regulatory submission to allow TTK Protective Devices Limited ("TTK") to manufacture CSD500, the Company's novel, erectogenic condom, has been approved by the relevant EU Notified Body with an extended shelf life for the product of 18 months.
TTK, part of the substantial Indian conglomerate TTK Group, is one of Futura's two manufacturing partners for CSD500. In addition to manufacturing CSD500 for worldwide distribution, TTK will also market and distribute CSD500 in India under its SKORE® brand, the fastest growing condom brand in India.
A separate regulatory submission (filed after the TTK submission) for the Company's European manufacturing partner to manufacture CSD500 with the extended shelf life of 18 months is also under review with the same relevant EU Notified Body. Confirmation will be made in due course as to the outcome of this submission.
James Barder, Futura's Chief Executive, commented: "At the time of our half year results in September, we highlighted that regulatory approval was imminent for TTK to manufacture CSD500 with an extended shelf life of 18 months. This is in line with the requirements of our commercial partners and we are pleased that this approval has now been received.
"Our manufacturing strategy for CSD500 comprises two manufacturing centres: one in Asia and one in Europe. Now that approval for our Asian manufacturer has been received, we will focus on obtaining the approval for our European manufacturer."
For further information please contact:
Aubrey Powell / Liz Yong / Thomas Smale
Tel: +44 (0) 20 7496 3000
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Notes to editors:
About 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.