Replies to post #15658 on GTC Biotherapeutics (fka GTCB)

[go seek]

LEO - ATryn - LFB from 3 Nov CC FWIW
In previous calls we have indicated that the patient recruitment into the phase II study in DIC, being run by LEO, has been slower than planned. Following an internal strategic review and reprioritization by LEO (a what?), GTC has entered into negotiations for the transition of the program for commercialization and clinical development for Europe and the Middle East from LEO pharma to LFB. LEO has confirmed that there are no safety or efficacy issues with the ATryn product, either commercially or in the phase II DIC clinical study.(hmm...OK?), LFB, currently a 20% shareholder in GTC, has expressed a significant interest in commercializing ATryn for its approved indications in Europe and continuing the development of ATryn in the ongoing phase II DIC study. Patients will not be recruited into the study until the completion of the transition which we are targeting to carry out by the end of this year. LFB is a partner who has already demonstrated a commitment to the development of recombinant plasma proteins, using transgenic production technology. We believe they will provide the appropriate focus and priority to the short-term commercialization and the longer-term development of ATryn in Europe and we are excited about the prospects for the future of this program. We also plan to initiate discussions with Ovation Pharmaceuticals regarding the transition of the ATryn license for Canada, currently licensed under the LEO agreement to Ovation. And you'll remember that we have yet to file in Canada for the approval of ATryn although we now have the data from our US study to enable us to move this process forward.

[MadCityCyclone]

i've always thought that atryn was mispriced. part of the goat's schtick is being able to produce cheaply. so why not sell the first one cheaply instead of at a premium price? and then rebrand at a higher price for other indications. or have a successful low margin product and let the higher ones follow. cox f'd it up when he jumped in bed with leo and assumed it was salad days.

[DragonBits]

Dew, that is a good explanation that hangs together on many levels.

[OKY]

Thank you Dew,
The road to success narrows every day. There are still
opportunities but it looks like GTC will need a lot more
time to make it big maybe 5 to 10 years (IMO) if they make it
at all, and by then there should be 5b shares outstanding, or
like that. Of course, unless something unexpected
happens, which is a possibility given the technology. Given
my age however and my retirement condition I guess I’ve
come out of my sit and wait stance and am now in the
please buy us out stance.

A pained LOL.

[vinmantoo]

Dew,

I agree with the price being set too high. Everything about LEO says they were incompetent. The price too high as well as the excruciatingly slow pace in getting rATIII for sale in the different European countries.


I disagree about your interpretation of the phase II data. The DIC trial has been limited and far too slow in recruiting patients so I would assume that they have no idea. That is the simplest interpretation of why Leo stated they don't have any safety or efficacy issues for rATIII in th trial.


I completly agree that hat LFB does regarding the DIC trial will be the evidence we need. If LFB rapidily moves forward with the DIC trails, we wlll know Leo's statement was accurate and we will also see more evidnce they were incompetent and the wrong partner for GTCB. The latter is more damning evidence that GTCB management made another blunder.