Futura Medical PLC
16 November 2006
For immediate release 16 November 2006
Futura Medical plc
CSD500 Regulatory Update
Futura Medical plc (AIM: FUM), the AIM-listed pharmaceutical group that develops
innovative products for consumer healthcare with expertise in sexual health,
announces that, together with distribution partner SSL International plc, it is
now proceeding with a user study. This will support the marketing launch of
CSD500 currently scheduled for the final quarter of 2007.
The decision to begin a user study follows meetings with the relevant Notified
Body & Competent Authority (Regulators) during which the remaining data required
to achieve EU regulatory approval for CSD500 was agreed in principle. This data
will be submitted as soon as practicable and is expected to resolve all
outstanding questions from the Regulators and to lead to EU marketing approval.
CSD500 will be marketed as a Durex(R) branded condom containing an active
compound which will enhance the barrier function of the condom. The active
compound will help healthy men maintain a firm erection during sexual
intercourse when using a condom.
Durex(R) has an approximately 30% share of the global market for branded condoms
with sales of £156 million in the financial year ended March 2006. Sixty-six
percent (66%) of SSL branded condom sales in that financial year were in Europe
where the first marketing authorisations are sought. Futura will receive a
milestone payment once marketing authorisation is granted within the EU and
royalty based payments from sales of the CSD500 condom.
James Barder, Chief Executive of Futura, said: 'We now have clear guidance on
the remaining data required to achieve marketing authorisation. Both companies
are fully committed to achieving a successful market launch of CSD500 next year.'
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 685 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Buchanan Communications
Mark Court / Rebecca Skye Dietrich Tel: +44 (0) 020 7466 5000
Notes
Futura Medical plc
Futura Medical is a pharmaceutical group that develops innovative products for the consumer healthcare
market with a strong expertise in sexual health. 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's primary focus is on over-the-counter products with particular appeal to men and women
who are reluctant to discuss potentially embarrassing sexual matters with their doctors.
Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock
Exchange.
www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange CAKPKNOBDDDDD
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