Goldshield Grp PLC - Re Marketing Authorisation

RNS No 3449h
GOLDSHIELD GROUP PLC
9th February 1999
                            

                    GOLDSHIELD GROUP
                   DICLOFENAC 2% SPRAY
         Application for marketing authorisation

A  Product  Licence  Application has been  submitted  for
Goldshield   Diclofenac  2%  Spray   under   the   Mutual
Recognition  Procedure  in  the  UK.  The  directors   of
Goldshield  expect that, subject to regulatory  approval,
the product will go on sale in the last quarter of 1999.

This  product  uses Goldshields patented technology  for
the  rapid  and effective delivery of drugs  through  the
skin  after  topical  application  by  spray.  The  spray
contains  the anti-inflammatory drug Diclofenac  for  the
treatment of acute and chronic joint pain.

Clinical  studies examining pain response were  conducted
on  40  patients with chronic osteoarthritis of the knee.
The  Goldshield  product resulted  in  clinical  benefits
giving pain relief at least equivalent to other available
remedies  over  the first few days but gave significantly
more rapid onset in pain relief.

In   contrast   to   currently  available   topical   gel
formulations   the   metered   delivery   of   Goldshield
Diclofenac Spray gives a precise dose for each  actuation
of the spray, allowing the patient to control exactly the
administered  dose.  This  is  particularly  useful   for
patients  with chronic arthritic conditions who  need  to
establish  an effective dose and regulate the total  dose
of medicine that they receive.

Blood levels of Diclofenac were also measured in patients
since   a   major  advantage  of  topically  administered
products  is that the harmful effects on other  parts  of
the body are reduced due to much lower levels of the drug
being  absorbed  into the bloodstream.  Blood  levels  of
Diclofenac with the Goldshield product were confirmed  as
being very low.

With  the in-vitro skin and patient studies suggesting  a
more  rapid  absorption of Diclofenac from the Goldshield
product  it  confirms  the superior  performance  of  its
transphase system for enhanced drug delivery. This result
is  encouraging  both for the Diclofenac  spray  and  for
other products under development.

The Non-Steroidal Anti-inflammatory Drug Market in the UK
is  currently worth #241 million, of which 15% is topical
gels  and 85% is oral therapy. Diclofenac Tablets  equate
to  25%  of  the oral therapy market and Diclofenac  Gels
equate  to 16% of the topical gel market. Several of  the
Non-Steroidal    Anti-inflammatory    drugs,    including
Diclofenac products, are marketed throughout Europe.

Ajit  Patel,  Chairman and Chief Executive of  Goldshield
said today:

"We  are  delighted that this exciting  product  has  now
passed  its clinical trial and we look forward  to  being
able  to  market this product in the UK and  licence  the
product to interested parties in Europe."

Contact:

Goldshield Group plc                      0181 649 8500
Ajit Patel, Chairman & Chief Executive

Buchanan Communications                   0171 466 5000
Andy Yeo/Tom Gadsby


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