Futura Medical PLC
12 August 2005
Press release 12 August 2005
Futura Medical Plc
Female Lubrication Device - Product development update
Futura Medical plc ('Futura' or 'the Company'), the AIM-listed pharmaceutical
and medical device group that develops innovative products for the sexual
healthcare market, today announced it has completed its clinical assessment
programme for the Female Lubrication Device ('FLD500').
Following a review of all the clinical data by Futura's panel of consultants and
supported by preliminary feedback from an EU competent authority no further
clinical work is planned prior to the submission of the dossier for FLD500 for
regulatory approval in the European Union. Work is continuing to finalise the
product, develop the manufacturing process and complete remaining supportive
data including stability in order to submit the dossier.
James Barder, Chief Executive of Futura Medical, said: 'This is further good
news for FLD500 and its progress to market, following SSL's exercise of its
option for global distribution rights for the product. The present clinical
assessment of FLD500 is considered sufficient for regulatory requirements and we
avoid the expense and time associated with conducting a further clinical study.'
In early July Futura announced that SSL International plc ('SSL'), the consumer
healthcare brands company and manufacturer and distributor of DurexTM, the
world's biggest-selling branded condom, had exercised its option for the global
marketing and distribution rights for FLD500.
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 845 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Abchurch
Samantha Robbins Tel: +44 (0) 20 7398 7700
mailto: samantha.robbins@abchurch-group.com www.abchurch-group.com
Notes to Editors:
Futura Medical
Futura Medical is an AIM-listed pharmaceutical drug and medical device group
developing innovative products for sexual health. The Company is developing a
portfolio of products with the intention of licensing their manufacture and
distribution to major pharmaceutical and healthcare groups. Several agreements
have been signed.
Futura's primary focus is on Over the Counter ('OTC') products with particular
appeal to men and women who are reluctant to discuss potentially embarrassing
sexual matters with their doctors. The Company has three products in
development and is in discussions to expand the pipeline.
CSD500 is a latex condom incorporating an erectogenic compound within its teat a
gel to help healthy men maintain an erection throughout intercourse, thereby
reducing the likelihood of condom slippage. An exclusive agreement for
worldwide distribution has been signed with SSL International plc, the maker of
DurexTM.
FLD500, aimed primarily at female partners of male condom users, will help women
maintain lubrication during intercourse, thereby reducing the risk of condom
failure. SSL International plc has exclusive worldwide distribution rights.
In trials, MED2002, a locally applied gel for erectile dysfunction ('ED'), has
shown dramatically improved dermal absorption rates and a dose-ranging study is
currently being conducted prior to commencement of a Phase III study. Futura
has entered into exclusive discussions with a major global pharmaceutical group
for the worldwide development and marketing of MED2002.
A trial to assess the safety of MED2002 in angina patients has already been
successfully completed. Subject to regulatory approval the Company intends to
recruit men suffering from ED with mild to moderate angina into the Phase III
trial. Normal medications taken by angina patients prevent the use of available
ED treatments such as ViagraTM, CialisTM and LevitraTM.
www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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