DCF100 Skin Study Results
Futura Medical PLC
06 September 2006
For immediate release 6 September 2006
Futura Medical Plc
New topical analgesics formulation
beats leading brands in human skin studies
Futura Medical plc (AIM: FUM) the pharmaceutical and medical device group, today
announces that its new topical non-steroidal anti-inflammatory (NSAID)
formulation, known as DCF100, has shown impressive results in recently conducted
in vitro human skin permeation studies with permeation rates in excess of eight
times higher than the world's current market leader.
Permeation through human abdominal skin was measured in a validated model for a
variety of formulations in studies conducted by Professor Mike Roberts at the
University of Queensland in Australia. Professor Roberts is a world-renowned
expert in skin permeability of pharmaceutical compounds.
The dramatic improvement in permeation rates observed in DCF100 formulations
compared with two over the counter topical brands, including the world's market
leader, Voltarol(R) Emulgel, is highlighted in a graph viewable at http://
www.futuramedical.co.uk/archive/060906_graph.pdf DCF100 also showed a
statistically significant improvement in drug delivered through the skin in a 24
hour period from a single dose compared with Pennsaid(R), a prescription based
topical NSAID which up until now has provided the best reported permeation rates
for topical Diclofenac.
Voltarol(R) Emulgel worldwide topical sales are estimated to be US$215 million
out of a current worldwide market for topical NSAIDs in 2005 of US$2.35 billion.
No topical NSAID has yet received marketing authorisation within the USA from
the Food and Drug Administration (FDA). This is due to concerns that NSAIDs
cannot permeate the skin in sufficient quantity to deliver a therapeutic dose.
This may however change with the regulatory dossier on Pennsaid(R) recently
being submitted to the FDA to obtain marketing authorisation due to its improved
skin permeation compared with existing topical NSAIDs. We expect the market for
topical NSAIDs to grow significantly once the FDA approves products.
Plans are at an advanced stage to conduct human tissue micro-dialysis and plasma
level studies later this year with Futura's preferred DCF100 formulation. These
studies aim to confirm local targeted delivery, thereby demonstrating the
potential for excellent clinical efficacy but without systemic uptake and the
associated side effects often associated with oral NSAIDs. In the meantime
discussions are underway with potential distributors for DCF100, the outcome of
which will be announced to shareholders in due course.
Professor Mike Roberts said: 'Topical formulations have sought to deliver an
effective therapeutic dose of Diclofenac from a safe and user friendly topically
applied formulation. Initial in vitro studies suggest Futura's DCF100
formulations deliver high effective doses of Diclofenac and are supportive of
their further clinical development for topical NSAIDs.'
James Barder, Chief Executive of Futura, said: 'These results beat our own
internal expectations and we see a significant opportunity to develop a further
valuable asset for our shareholders at limited cost and risk. These studies
also support our belief that our delivery system, initially developed for
MED2002, has significant commercial applications beyond MED2002.'
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 685 670
email to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Buchanan Communications Tel: +44 (0) 20 7466 5000
Mark Court
Notes
Futura Medical plc
Futura Medical is a pharmaceutical drug and medical device group largely
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.
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
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