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ICX-TRC Regulatory Announcements


#1

I have selected the parts most important for ICX-TRC

More Info can be found at http://www.intercytex.com/icx/investors/rns/rnsitem?id=1174633281nRNSW5680T&t=popup

                             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.

Highlights

Products

  • Good recruitment progress in Phase III trial of ICX-PRO for venous leg
    ulcers

  • 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

Commercial Development

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 This was withdrawn in November 2006 because, despite good sales, being an autologous product with high manufacturing costs it was reported to be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.

Clinical Development
ICX-TRC

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.

Regulatory developments

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
force.

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.


#2

This is good news. They say that results will be announced sometime in the middle of this year so maybe June or July. They are also still toying with the idea of a 2008 early release of ICX-TRC. Hopefully they get good results and the MHRA allows them to release next year.


#3

OK,for arguements sakes lets say it’s released next year.
Have you wondered just how much this procedure will cost ? If BHT are so damn expensive how much do you think they will charge for HM ?
My biggest fear is that this product will be released but will be so expensive that it will be out of most peoples reach.


#4

As stated before the cost is estimated around the BHT’s cost.

I am curious though to see how they will cost the treatment, per DP or per injection?


#5

» As stated before the cost is estimated around the BHT’s cost.

That is expensive but at least there are no white dots,no 2 year wait for the hairs to grow & an endless supply of hair.
Fingers crossed.


#6

» This is good news. They say that results will be announced sometime in the
» middle of this year so maybe June or July. They are also still toying with
» the idea of a 2008 early release of ICX-TRC. Hopefully they get good
» results and the MHRA allows them to release next year.

first results are now plannet to second half of 2007. this will be results of first cohort of 6 people. phase II needs to have 60 or so. so it took them one year, to make 10% progress in phase II. hopefuly once they shed all the remaining safety & dosage unknowns, they will be able to treat more people at once.


#7

» OK,for arguements sakes lets say it’s released next year.
» Have you wondered just how much this procedure will cost ? If BHT are so
» damn expensive how much do you think they will charge for HM ?
» My biggest fear is that this product will be released but will be so
» expensive that it will be out of most peoples reach.

Small-scale commercialisation probably means this:

At one or two commercial clinics in the UK, ICX-TRC will be offered to qualifying patients as part of an expanded Phase III study. That is, the procedure will still technically be in clinical trials, but they will accept a limited number of paying patients (depending on the scale of their facilities and staff, there may be a waiting list.) I think they can only go ahead and do this with permission from the MHRA.

So that means anyone who wants the procedure will have to travel to, and spend a fairly significant amount of time in, the UK.

OTOH, small-scale commercialisattion could also mean making the procedure available in another country which has granted early regulatory approval.

In any event, small-scale commercialisation WILL NOT mean instant availability in the US. For Americans, at least, anyone who wants HM will have to spend significant money, taking time off to travel and stay in a foreign country.