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New intercytex report


#1

this was uploaded on their website today

http://www.intercytex.com/icx/investors/rep/rep2008/health_conference/health_conference.pdf


#2

» this was uploaded on their website today
»
» http://www.intercytex.com/icx/investors/rep/rep2008/health_conference/health_conference.pdf

Thanks nathan.

Out of all their products there, TRC has the least amount of pages which shows that its their least important product atm. But anyway thanks for bringing it up.


#3

» this was uploaded on their website today
»
» http://www.intercytex.com/icx/investors/rep/rep2008/health_conference/health_conference.pdf

big whoop
They’ve been at this… for what?.. 6+ years now? The new report says they only had “10 evaluable subjects”. They recently discovered better results on 5 of those subjects with dermabrasion, so what did they do? Without putting some additional research in this aspect they decided to give up until someone gives them more money. Oh yes, it all makes perfect sense **cough **sarcasm **cough

.


#4

TRC does indeed have the least amount of coverage on that file but i think that’s because of commercial sensitivity.

It confirms though that they’re seeking a partner.

Look at page 8. It looks as though they’re following a very similar pattern to vavelta ie launch and clinical work.

On the same page look at the details for ICX PRO and you’ll c that they’ll be seeking a partner after phase III for that product as they feel they need more data to launch.

Some countries need to see more evidence of efficacy as opposed to others hence the reason y they want to carry out more trials whilst launching the product in other countries to fund those trials.


#5

» TRC does indeed have the least amount of coverage on that file but i think
» that’s because of commercial sensitivity.
»
» It confirms though that they’re seeking a partner.
»
» Look at page 8. It looks as though they’re following a very similar
» pattern to vavelta ie launch and clinical work.
»
» On the same page look at the details for ICX PRO and you’ll c that they’ll
» be seeking a partner after phase III for that product as they feel they
» need more data to launch.
»
» Some countries need to see more evidence of efficacy as opposed to others
» hence the reason y they want to carry out more trials whilst launching the
» product in other countries to fund those trials.

whatever floats your boat bub.

.


#6

» TRC does indeed have the least amount of coverage on that file but i think
» that’s because of commercial sensitivity.
»
» It confirms though that they’re seeking a partner.
»
» Look at page 8. It looks as though they’re following a very similar
» pattern to vavelta ie launch and clinical work.
»
» On the same page look at the details for ICX PRO and you’ll c that they’ll
» be seeking a partner after phase III for that product as they feel they
» need more data to launch.
»
» Some countries need to see more evidence of efficacy as opposed to others
» hence the reason y they want to carry out more trials whilst launching the
» product in other countries to fund those trials.

Wow…I admire your blind optimism in TRC. You are probably the most optimistic person about Intercytex, even after that horrible march report. Interestingly, I’ve never seen your posts on anything other than Intercytex/TRC? This could mean only one thing, that you’ve some vested interest in Intercytex:

i) You got excited and bought loads of ICX stock, and now watching them take a dip hurts you.
ii) OR, you are linked to Intercytex in some way (employee, know someone close who works there?), and feel bad hearing negative stuff about it.

so, what’s what nathan?


#7

not sure y you’re saying the march report was horrible when many people found it be the opposite ie report of new hair growth and phase III being eliminated meaning a potentially quicker route to the market.

My opinions r my own


#8

phase III being
» eliminated meaning a potentially quicker route to the market.
???

They way most of us read the report…basically TRC was being eliminated from their products ??? I dont know how you could read that report any other way Nathan…Optimism is good…but building up false hopes is bad :no:


#9

If it was eliminated it would have been in scrapyard rather than being presented to a conference in Italy


#10

extremely poor, regarding TRC.


#11

ICX-TRC looks about finished. I don’t see it hitting the commercial market any time in the next 5 years at least.

I don’t see TRC getting any more significant investment at this point. Not unless both Folica & Acell turn out to offer absolutely no new commercial hair growth potential at all.


#12

“Intercytex’s strategy is to complete product development and to gain marketing authorisation in North America and Europe. A small sales operation will be established to serve specialist segments but the Directors anticipate that the products developed by the Group will require significant investment in marketing and distribution in order to maximise returns. For this
reason, the Group’s strategy is to seek distribution partners as the products near regulatory approval. Manufacturing will be retained in-house for in-market supply”

Make your own minds up


#13

» “Intercytex’s strategy is to complete product development and to gain
» marketing authorisation in North America and Europe. A small sales
» operation will be established to serve specialist segments but the
» Directors anticipate that the products developed by the Group will require
» significant investment in marketing and distribution in order to maximise
» returns. For this
» reason, the Group’s strategy is to seek distribution partners as the
» products near regulatory approval. Manufacturing will be retained in-house
» for in-market supply”
»
»
» Make your own minds up

nathan, is this text referring to TRC?
where did you get this text? Its not in the pdf you posted.


#14

» “Intercytex’s strategy is to complete product development and to gain
» marketing authorisation in North America and Europe. A small sales
» operation will be established to serve specialist segments but the
» Directors anticipate that the products developed by the Group will require
» significant investment in marketing and distribution in order to maximise
» returns. For this
» reason, the Group’s strategy is to seek distribution partners as the
» products near regulatory approval. Manufacturing will be retained in-house
» for in-market supply”
»
»
» Make your own minds up

Where did you get this from? definitely not from the report that you mentioned in this thread. Also, our beef isn’t that the product won’t work. Just that it won’t be available in 2008 as YOU assured us. And what we got from Dr.kemp’s interview was that they will proceed with phase-III before its available for people.

Best Case Scenario: Now assuming that phase-III is the small scale commercialization that everyone wanted. Still as per Dr. Kemp phase-II will finalize around March 2009, and then several months are required to setup phase-III. So even with the best case, the earliest small scale commercialization is 2010 - as mentioned on ICX website. Unless obviously you have some insider news :wink:


#15

Yes, it’s referring to TRC.

I’ll paste you some other key points mentioned with regards to TRC.

“Intercytex plans to have appointed a distributor for the USA before or during registration so that the distributor can prepare for launch as soon as authorisation is achieved. Intercytex has an option agreement already in place that gives Bosley Medical a right of first negotiation and precludes Intercytex from offering improved commercial terms to other parties for a period of 6 months following termination of negotiations with Bosley. Intercytex has confirmed that the timing of negotiations would be such as to avoid any delay in commercialisation.”

“Intercytex had a pre-IND meeting with the FDA in 2005 to discuss the next stage”

“Bosley Medical has been granted an option giving the company the right of first negotiation to commercialise IXC-TRC. Bosley could provide immediate access to over 7,000 patients, together with 13 clinics and 80 information centres to support pre- and post-launch education and communication programmes.”

“Currently the product is manufactured at the Group’s Manchester facility. In the USA a manufacturing facility will be set up at the same location as that for ICX-PRO; this is planned to become operational in 2009 in time for product launch”

“It is highly unlikely that reimbursement will be obtained and Intercytex plans to market to the private sector. Initial users are likely to be hair transplantation specialists. Ultimately it is possible that the product will be adopted by dermatologists.”

“Commercialisation may only be possible in the USA with appropriate regulatory approval. Even if approved for marketing, the level and quality of hair coverage achieved will need to be cosmetically attractive for commercial success. Scepticism towards currently available remedies and lack of awareness of the results that can be achieved using current hair restoration procedures may prove a barrier. Working with an organisation such as Bosley Medical should help to overcome this.Intercytex requires a US commercial partner with sufficient critical mass to undertake the necessary educational and communication campaigns during the pre- and post- launch phase. Failure to secure a suitable partner would be a major barrier to market entry.”


#16

Interesting info…where did you get it from? link to full report?

» "Intercytex plans to have appointed a distributor for the USA before or
» during registration so that the distributor can prepare for launch as soon
» as authorisation is achieved.

What is registration? authorization for what? is it talking about the phase-III? and authorization from whom…FDA??

Even though this is good news and implies that Intercytex is still optimistic about their product, it still doesn’t deny the earliest 2010 commercialization timeline. It especially doesn’t talk about commercialization in a country with less restrictions - the only option to get it to market asap!


#17

I’ve still not convinced that TRC will work satisfactorily even after phase#3.

Phase#2 looked like a developmental failure. The whole concept should have turned out some much better looking regrowth by now. The results they’re getting don’t seem to be much beyond what could be achieved with the “scalp stimulation” (read: dermabrasion) step alone. And that is virtually nothing in terms of cosmetic impact.


#18

y was Phase II a developmental failure ???

They reported substantial hair growth. How is that a failure ??

Just because they havent been too specific doesnt mean that the results r poor.


#19

» Interesting info…where did you get it from? link to full report?
»
» » "Intercytex plans to have appointed a distributor for the USA before or
» » during registration so that the distributor can prepare for launch as
» soon
» » as authorisation is achieved.
»
» What is registration? authorization for what? is it talking about the
» phase-III? and authorization from whom…FDA??

I think registration is = FDA approval after phase III.

I think Nathan is posting old info. They say that they plan to use Bosley for distribution after clinical trials are completed. These are the old plans.
Now things are different. ICX now doesn’t want to pay for Phase III and they want Bosley to do it.

quote:

“Currently the product is manufactured at the Group’s Manchester facility. In the USA a manufacturing facility will be set up at the same location as that for ICX-PRO; this is planned to become operational in 2009 in time for product launch”
<<

You see, Nathan is posting old plans. 2009 launch!! these are old plans!!

Nathan, where did you get this information,
and how old is it?


#20

» Interesting info…where did you get it from? link to full report?

http://www.intercytex.com/icx/investors/rep/otherdocs/2006-08-03/at_aim.pdf