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auxilium
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06/08/2004 23:14
Jee

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06/08/2004 23:14
Jee

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auxilium

Who is Auxilium? I gather it is not a public company. What is their financial commitment and what kind of financial resources do they have? What is their time frame? what is their distribution capability? What is their history vis a vis other products? If they "commercialize" does that mean they manufacture,advertise, produce etc.? Are they furthering and paying for the effort to get through the regulatory trials? Do they have a marketing arm and capability?
The press release leaves just a few unanswered questions.

06/08/2004 23:40
anon

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06/08/2004 23:40
anon

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answers

go to www.auxilium.com and it shows they do have money - 43 m in latest round of financing. Looks like they've filed to go public soon too.

06/08/2004 23:25
Randy H.

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06/08/2004 23:25
Randy H.

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The Optimistic Scale

This can only help...."*Development* And License Agreement " can only mean that Auxilium is going to kick in to finish the job of getting Collagenase approved for Dups. After all, without that, Dups "Cordease" is worthless. I'll bet you my new SONY flat panel that these guys don't know what's coming regarding NA. While the injections will give us all another choice, let's face it: economically, NA is a Collagenase competitor as they essentially do the same thing. NA, however, will always be far cheeper and from all we've read, at least as effective.

The timing of all this may be to our long term benefit. If Collagenase was good to go *now*, Eaton would probably have been using it and would not have traveled to France. No compelling need. Insurance will cover Collagenase just it now does surgery. It's still going to take these boys a few years to get approval, so there is plenty of time for NA to take hold in the US (though the window is now smaller). The race is back on as to which will prevail. For our sake, let's hope they can coexist. There may be some cases where Collagenase will be more effective that NA. Either way, surgery will be out of vogue and relegated to the category of last resort .

06/08/2004 23:42
jim h

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06/08/2004 23:42
jim h

not registered

The Optimistic Scale

Maybe more complicated than that. With the cutting tool used for NA, a surgeon can to some extent cut what and where he wants, limited by the fact that he can't direcly see what he's cutting - guided by feel and his knowledge of the hand's structure. Collagenase isn't so precise. The idea is to inject an amount sufficient to dissolve the band to the point that it can be snapped, but that amount isn't exactly known, so I expect more trial-and-error, with emphasis on the 'error' part. Collagenase will probably be marketed as a way to accomplish what NA does without the need for comparable skill and experience. MDs using Collagenase will err on the side of caution, and in some cases fail where NA would have succeeded. So I think NA is here to stay.


06/08/2004 23:31
Randy H.

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06/08/2004 23:31
Randy H.

not registered

The Optimistic Scale

I talked quite a bit to the UCLA doc who will now apparently get funded to run one of the 4 necessary PhaseIII sites. What needs to be ascertained is whether or not the Collagenase will dissolve **only** Dups tissue, or whether it might attack healthy tissue in some cases. The whole idea of the enzyme is that it should only dissolve the Dups cords and leave everything else alone. So far, it's worked perfectly. No other tissue has been effected. However, as you might expect, it's been used sparingly, as **no one knows** exactly how far you can push it. Also, the long term effects are unknown

Well, if it turns out that you can inject a ton of this stuff with complete safety, now you can fix the cases that prove difficult for NA. It will not matter where and how the Dups is growing.....It's toast. (This is at the far end of the Optimistic Scale) We will not know how far this technology can be pushed until someone's hand dissolves just a bit. Then we'll know. I've always wanted this approach added to the arsenal because it has the potential to completely render Dups surgery a thing of the past. Even those who defend surgery will get on board for that.

06/08/2004 23:35
steve 
06/08/2004 23:35
steve 
collagenase

If you read the Phase II results (www.pubmed.com search for badalamente and find article from 2002) you will find the big advantage for collagenase is that the recurrance rate is 5-10% after several years where NA is over 50%, so collagenase has the potential to be a longer term solution and one could hope a cure but the data for real long term results just isn't known. They did determine the dose amount that was optimal in the Phase II trials too so I don't think its about finding the right dose from what I've read. When does the UCLA doctor think he will be able to start up?

06/08/2004 23:03
jim h

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06/08/2004 23:03
jim h

not registered

ahh.

Man that sounds good. Until I remember they haven't even really started Phase III yet. This is still s-o-o-o far off in the distance.

The potential for Peyronie's and Ledderhose is tremendous. Those conditions can't be helped by something like NA, they would require the dissolving action of Collagenase.

06/09/2004 23:15
Randy H.

not registered

06/09/2004 23:15
Randy H.

not registered

ahh.

He was ready to get started and I was hoping to get on his list of subjects over a year ago. He conformed however, that a lack of finding on BioS part had held up the project. I'm assuming that this new partnership is partly designed to get past the money jam. It's still a few years away though because the subjects hands will need to be monitored for some time before the feds will sign off on it. I'll check in a month or so and see if it's back on track by then.

06/09/2004 23:23
steve 
06/09/2004 23:23
steve 
ahh.

I thought you had talked to the dr at ucla yesterday....i would imagine it might take a few months for money to transfer from such a deal and the new company partnering with them to decide on exactly how it should be spent. But auxilium probably wants to move faster than not if given the choice.

06/10/2004 23:20
Tom M

not registered

06/10/2004 23:20
Tom M

not registered

additional consideration

A further thought...It remains to be seen what the role of collagenase will be regarding nodules. NA does not appear to be an option for eliminating nodules, but perhaps collagenase injections will have a role in that regard.

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