Agreement with GSK
Futura Medical PLC
04 July 2006
For immediate release 4 July 2006
Futura Medical plc
Announces agreement to develop non-prescription
treatment for erectile dysfunction (MED2002) with GlaxoSmithKline plc
Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group
that develops innovative products for sexual health, announced today it has
entered into a development agreement with GlaxoSmithKline Consumer Healthcare
(GSK CH) for Futura's topically applied gel (MED20021) for the treatment of
erectile dysfunction (ED). GSK CH is a division of GlaxoSmithKline plc
(GlaxoSmithKline), the global pharmaceutical and healthcare group.
If successful, MED2002 would be the world's first non-prescription
pharmaceutical treatment for men with ED. By being available from pharmacies
without the need for a doctor's prescription, MED2002 will be a convenient
treatment for men with ED.
While some treatments are taken orally or injected, MED2002 is topically applied
and provides a rapid onset of action. This has considerable advantages in terms
of giving a local rather than the systemic effect that is associated with other
current ED treatments.
Treatments such as phosphodiesterase inhibitors, such as sildenafil, tadalafil
and vardenafil, have revolutionised the market for ED. This has led to an
enormous increase in public awareness of this condition, which affects, to some
degree, 50 per cent of men aged 45 or over. It is expected that the number of
men with ED will double from its current level of 152 million worldwide to 322
million by 2025 due to ageing populations2. Despite this, it is estimated that
only 15 per cent of men with ED will seek prescription treatment3. This is
attributed to the embarrassment associated with the need, on all current ED
pharmaceutical treatments, to consult a doctor in order to obtain a
prescription.
GlaxoSmithKline will provide global regulatory and technical support for
MED2002. The program, to be run and managed primarily by GlaxoSmithKline, is
expected to comprise up to three studies involving approximately 1,500 men with
ED and several additional safety studies to support the existing studies already
completed by Futura. The clinical development program is already in an advanced
stage of planning and is currently expected to complete in time for regulatory
submissions in 2008.
The first clinical study that both parties have committed to is expected to
commence before the end of 2006. Under the terms of the agreement
GlaxoSmithKline will pay 65% of the clinical development program costs for
MED2002 and Futura will pay 35%. The cost of the entire clinical development
program is expected to be about £3.65 million which would result in a
contribution from GlaxoSmithKline of about £2.4 million.
The Agreement also includes licence terms that are not yet legally binding but
are intended to be incorporated into a global licence agreement to be negotiated
and executed by both parties for MED2002 following final approval from GSK.
Under these terms GlaxoSmithKline would have global distribution and marketing
rights for MED2002 for the lifetime of the MED2002 patents, currently expected
to run until around 2024. Negotiations of the detailed terms and conditions are
continuing with the intention of executing the licence agreement as soon as
practicable. The clinical development program will run in parallel.
Under the licence agreement, Futura would also grant GSK first refusal rights on
two other products currently in the early stages of development: a
non-prescription treatment for arousal and desire disorders associated with
female sexual dysfunction and a non-prescription treatment for premature
ejaculation.
James Barder, Chief Executive of Futura, said: 'Over the past year we have
developed a close working relationship with the team at GlaxoSmithKline and have
been impressed by the dynamism, professionalism and expertise they have brought
to the development of MED2002. We look forward to continuing this extensive
collaboration and converting the potential of MED2002 into a leading product as
the world's first licensed non-prescription treatment for men with erectile
dysfunction.'
Paul Berman, VP Business Development and Strategic Planning, GlaxoSmithKline
Consumer Healthcare Europe, said: 'This is a very exciting new business
opportunity for GSK Consumer Healthcare, one that meets a significant unmet need
in the marketplace, and the prospect to be the first regulatory approved
non-prescription erectile dysfunction product is compelling. We have an
extensive clinical development program ahead and we look forward to working with
Futura Medical to fulfil this opportunity.'
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 Tel: +44 (0) 20 7466 5000
GlaxoSmithKline Consumer Healthcare
Claire Dixon Tel: +44 (0) 20 8047 4296 /
+44 (0) 7717 801 391
1. MED2002 is the term used by Futura to describe all the different gel
formulations applied directly to the penis for the treatment of male erectile
dysfunction. Futura may code certain formulations, for identification purposes,
by altering the final digit. For example MED2001 or MED2004.
2. BJU Int, July 1999, vol. 84 part 1, pages 50-56
3. Prog Urol February 2003, vol 13 part 1, pages 85-91
Notes
Futura Medical plc
Futura Medical is a pharmaceutical drug and medical device group developing
innovative products for the sexual health market. 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.
For further details please visit www.futuramedical.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange