| Lost password
165 users onlineYou are not loggend in.  Login
Auxilium AA4500 Phase 3 Clinical Trial Experience
 1 2 3 4
 1 2 3 4
11/12/2007 17:34
Randy_H 
11/12/2007 17:34
Randy_H 

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Trevb

Those of us who have followed the Collegenase journey for four of five years have seen this product sputter far too often. The trials are on. The trials are off. And on it goes.

That said, we have so much conformation that the trials are now resumed in earnest it's hard not to be hopeful. Still, even after the trials are finished it takes some time for final FDA approval. If I had to take a stab at it I'd say between 12-24 months from now. After six years in "the pipeline", that's almost as soon as tomorrow!

11/12/2007 19:21
JAnnRunner 
11/12/2007 19:21
JAnnRunner 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Thanks, I hope to hear something by Wednesday on starting the study Monday the 19th. I am hopeful and optimistic that all will go well .... I will keep you all posted..J Ann

11/13/2007 15:32
TrevB 
11/13/2007 15:32
TrevB 

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Quote:



Trevb

Those of us who have followed the Collegenase journey for four of five years have seen this product sputter far too often. The trials are on. The trials are off. And on it goes.

That said, we have so much conformation that the trials are now resumed in earnest it's hard not to be hopeful. Still, even after the trials are finished it takes some time for final FDA approval. If I had to take a stab at it I'd say between 12-24 months from now. After six years in "the pipeline", that's almost as soon as tomorrow!



That's good news for people like me who have Dups in their one good hand which hasn't yet got contracture. I wonder if it was only available in the USA initially whether we'd see patients travelling over there, much like they went to France for NA or Germany for radiotherapy


Edited at 13.11.07 17:34

11/13/2007 18:32
jim_h 
11/13/2007 18:32
jim_h 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

5-6 years? Trevb, you are being too generous. I remember reading a paper describing a successful Phase I trial at Stony Brook in '96, before I had my first surgery. The story continues through 10 years of on-again, off-again trials, rounds of fund-raising alternating with running out of money, BSTC selling the rights to Auxilium, a CEO departure via golden parachute, manufacturing problems, and more plot twists which I've forgotten.

In my opinion it's futile to speculate about when, or even if, this product will ever be available. My take on it is: it will be available when the right people are convinced that's the way they'll make the most money - as opposed to simply continining to bring in new investment cash by keeping the product perpetually just over the horizon.

11/14/2007 15:06
TrevB 
11/14/2007 15:06
TrevB 

Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I always try to remain positive Jim on things that are vital to my well-being and this sure fits that category. If it was a financial donkey then I wouldn't have thought that we'd have got to the late stage we now seem to be at? I have to say that in life generally my glass is half empty. I'm prepared to take the opposite view for one time only with this and keep everything crossed I hope that my optimism isn't misplaced?

Does anyone know why it appears so difficult and expensive to produce this stuff. How much would a course cost if it is ever available

Edited at 14.11.07 17:13

11/14/2007 18:21
Randy_H 
11/14/2007 18:21
Randy_H 

Marketing, Marketing, Marketing

I've heard cost will be about $5,000. (That's $500 for the actual stuff / $2,500 to replay FDA approval costs / $500 for sales and marketing / $500 for the CHS to inject it / $1,000 profit back to the investors)

I'm only *half* kidding about that. I may not be too far off. The idea is that insurance will cover it and still cost less than Open Surgery.

None of this takes into account the relative merits of NA at no more than $1,000. I want to see Collegenase be made available so I've always been concerned that those of us in the NA movement and the MD's that we now have on board might become *too* successful and we wind up shooting ourselves in the foot. I think it's now too late for that. The Collegenase marketing machine and CHS reluctance to cut what they can't see will win the day for Auxilium and BioS. NA growth will stop in it's tracks. Still, those in the know will still use NA it if it's less expensive for them personally, especially for an MCP. Overall we should be pleased with how things are developing.

11/14/2007 22:29
jim_h 
11/14/2007 22:29
jim_h 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I'm actually somewhat optimistic. BSTC/Auxilium execs have "worked" investors for many millions over the last 10 years, but in some maddengly slow way they continue inching towards the market. At this point, stalling the trials again on some pretext might cost them too much credibility to launch another round of fundraising.

The cost? In one of their glowing investor presentations, Auxilium stated that this drug should "command a premium price" as the only alternative to surgery. And that's clearly their plan. Insurance companies may decide to grant them that price if it's $10 below conventional surgery and PT.

BUT - Collagenase is in some ways a crude solution - you inject it into the cord and hope it disolves enough of it to allow it to be snapped. If the first injection doesn't do it, you pony up another $1,000 and shoot again, or give up. You can only have a very small number of these injections, lest they leak out and damage good tissue. Insurance companies might decide to fund only a couple of injections.

A skillful NA practicioner can keep sawing at that cord until it gives up. He's in full control of the cutting tool, it isn't just an injected chemical mindlessly dissolving its way through the tissue. As these guys acquire experience, they're going to get even better at releasing difficult contractures.

I think insurance will continue to pay for NA, especially if it's cheaper than collagenase. I also think NA can and should become even less expensive than it is today. Remember the Europeans have been doing it for decades for a fraction of the cost here in the U.S.

11/14/2007 23:35
Randy_H 
11/14/2007 23:35
Randy_H 

Lighting the Fire

"Remember the Europeans have been doing it for decades for a fraction of the cost here in the U.S."

Jim,

Europeans do *everything* cheaper medically speaking. What Eaton set as the benchmark for NA was the equivalent to his time per hour in the OR. Why would that change unless non-CHS get involved at their lower (non-sergical) rate per hour?

Also, perhaps the guys at Auxilium realized that at the rate Eaton is spreading the gospel of NA they'd better come to the party now, if at all. You have to *know* they attended the ASSA presentation that included a discussion of the future of Collegenase. They must have got an eyeful of NA for their trouble. If that didn't light a fire, nothing could :-)

11/15/2007 02:59
jim_h 
11/15/2007 02:59
jim_h 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

Right - the French MDs doing this procedure, whom I first learned about 10 years ago, were rheumatologists, not surgeons. We're incredibly uptight about medicine in this country, and we pay a big financial price for it. Sure this is an invasive procedure, but so is a root canal. In fact, I think a root canal is probably a lot riskier. It would be great to have heavyweight hand surgeons like Dr. Charles Eaton study, perfect and teach this procedure, but I think it could probably be safely performed by many skilled MDs.

11/15/2007 04:13
bshatzer 
11/15/2007 04:13
bshatzer 
Re: Auxilium AA4500 Phase 3 Clinical Trial Experience

I had my prelimary exam last Thursday, was notified I was accepted for the study on Monday and am scheduled for my first (and hopefully only) injection this coming Monday.

I'll post a report - assuming I can type afterwards. The disclosure and consent form said "there is some discomfort associated with the procedure" - I assume that's a technical phrase meaning "this is gonna really hurt!"

 1 2 3 4
 1 2 3 4
establishment   contraction   Collegenase   injections   fingers   another   Clinical   appointment   available   rheumatologists   correspondence   Auxilium   injection   scientifically   Experience   stretching   contracture   surgery   treatment   dupuytren-online