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23rd March, 2007 Intercytex Group plc Preliminary results for the year ended 31 December 2006
Intercytex Group plc (LSE: ICX) announces its unaudited preliminary results for
the year ended 31 December 2006.
Intercytex is the leading cell therapy company focused on high impact treatments
to restore and regenerate skin and hair. Intercytex uses its fully integrated
cell technology platform to develop living, human cell-based products, at
commercially viable scale in attractive markets.
Good recruitment progress in Phase III trial of ICX-PRO for venous leg
Commencement of Phase II trial of ICX-PRO in diabetic foot ulcers
Successful completion of Phase I trial of ICX-RHY for facial rejuvenation
Commencement of Phase II trial of ICX-TRC for male pattern baldness
£1.85m grant to automate production of ICX-TRC
MHRA confirmation that ICX-RHY can currently be sold in the UK without
a marketing authorisation
In March we received confirmation from the MHRA that ICX-RHY is outside the
scope of the current legislation covering the marketing of medicines and devices in the UK; since it therefore does not need a marketing authorisation we are able to launch the product in the UK. We are also reviewing the opportunities in certain other European markets.
Since receiving the letter from the MHRA we have been evaluating the market
opportunity and preparing for launch. Until recently the only cell therapy
approach to facial rejuvenation on the UK market was the autologous product,
Isolagen. This was withdrawn in November 2006 because, despite good sales, being an autologous product with high manufacturing costs it was reported to be
unprofitable. Our market research has shown that there remains a strong appetite amongst aesthetic doctors for the natural outcomes which a cell therapy approach to facial rejuvenation could achieve. We are therefore confident that ICX-RHY will be well received and that, as an allogeneic product with a much simpler manufacturing process, it will achieve satisfactory margins.
We are investigating whether there are opportunities to initiate the small scale commercialisation of ICX-TRC in 2008. This will depend on the outcome of the ongoing Phase II trial and further regulatory review.
We started a Phase II trial of ICX-TRC, our cell therapy product for hair
regeneration in male-pattern baldness, in September. The process involves taking a biopsy from the subject, separating out the relevant cells, and growing them in our facility using our proprietary process. All biopsies from the first cohort of 9 patients have been taken and most of these patients have been treated. Further cohorts will follow investigating variations in delivery
technique. We expect to report preliminary data from this trial around the
middle of the year.
Advanced Therapies Medicinal Products (ATMP) Regulation (2005/0227/COD)
Although currently ICX-RHY is not regulated in the UK as either a device or a
medicine we believe that in time it will become regulated by pending European
legislation covering ATMPs. This legislation is currently in draft form and we
do not anticipate that it will become law in the UK until sometime in 2008. The
legislation will contain ‘grandfather’ provisions allowing for the continued
sale of products which were available prior to the legislation coming into
The new legislation will also probably regulate ICX-TRC and ICX-SKN as ATMPs
which are both currently regulated as medicines in the UK. We do not expect the new regulation to have any significant effect on the development path of either of these products.