andyd

"are there any side effects on normal hand tissue?"

That is exactly what the FDA trials are needed for. So far it looks great, no problems. However, in spite of the rosy "forward looking" projections by the speaker on this *great* audio, they are sill years away. See the thread below: "Collegenase"

Thank you so much for this link andyd. For the first time we have it from the horse's mouth that Collegenase will be priced "comparable to surgery", which in their understating is about $5,000. It's obvious that they know full well that *demand* will drive the price since they control the *supply* worldwide. They are also banking that most surgeons and patients would rather go this route than Open Surgery, even at the same price. I believe they are exactly right.

Here is the catch:

Now that NA has now been presented to the American Society of Surgery of the Hand and has shown to be safe and effective, the speaker, if he knows his business, *must* be aware that NA is a significant competing noninvasive procedure. Instead he says **repeately** that the only current treatment is surgery. Listen carefully. He means full Open Surgery. He, my friends, is dead wrong and that is an incontrovertible fact. Is the speaker intentionally misleading the audience or does he have his head in the sand?

Remember, he is talking to investors and media. He is making the case that there is money to be made here because for $5,000 their future customers will be able to *avoid* surgery. I concur. However, the Elephant in the Room is that we can avoid surgery *now*, and in almost the same way for less than $1,000.

Bottom Line: Auxilium needs to get this puppy to market before the knowledge and success of NA goes any further. As the man said, there is a Billion dollars riding on this. If NA catches on, their whole business model crashes to Earth because they will no longer control the "supply" of a non-surgical solution.

I'm not looking to put a crimp in Bios/Auxilium's style here, but I'm not going to let such a gross inaccuracy go unchallenged.


Edited at 05/27/07 22:07

andyd:

"The effect of the Collegenase seems to be to weaken the fibres that are then physically snapped. I was interested to know if it had a similar effect on other tissues eg ligaments etc."

The effect of Collegenase is *identical* that of NA. The cord is weakened at one or two ideal places, the finger stretched back into normal extension and the cord is broken releasing the finger. The only difference is how you weaken the cord(s). One is with a $10,000 motorcycle (NA / mechanical) and the other with a $50,000 Lexis (Collegenase / Bio-mechanical).

Don't get me wrong. We should all be rooting for Collegenase approval because it may well prove to do things that simple NA can't. However in terms of it's current proposed use, NA has already been there, done that.

So why do CHS seem more interested in Collegenase than NA? That is the One Billion Dollar Question, quite literally. The #1 objection that CHS seem to have is the risk of nerve damage. However, this is merely an assumption, as there is no data to back up that fear. In fact, Eaton/Denlker/Press have shown that the risk is equal to or *less* with NA. The data is clearly on the side of NA.

ANSWER: CHS strongly object to doing a "blind" procedure where they can't actually see what they are cutting. As in the words of George Bush, Sr.: "Not gonna do it". Injecting an FDA approved chemical is apparently fine. They aren't cutting anything. The Collegenase is doing the "cutting". Apparently a big difference to them.

The #2 objection is an unacceptable higher rate of recurrence. Again, clinical data in well over 1,000 patients has shown this to be totally unfounded. But here is what I find really fascinating. Why isn't that same objection of recurrence raised with Collegenase? There is no reason to put these two, NA and OS, in different categories. None. And yet you never hear a peep abut recreance fears. In fact, if you listed to the webcase from Auxilium, Collegenase is presented as a *replacement* for OS, not simply an entry level less invasive first procedure of choice. The truth is that NA *does* have a somewhat higher rate of recurrence which is unacceptable in some cases. Then you need OS. The same will be true of CI (Collegenase Injections).

Edited at 05/29/07 08:43

Jim,

My lumping CI (as it is now proposed) and NA together as equivalent procedures is from the perspective of comparison to full OS. My proposition is that they are so similar, recurrence rates should be very close to the same. Also, by comparison, NA and CI are brothers when it comes to being non invasiveness. I do agree that theoretically nerve damage should be at Zero for CI, which is significant, yes. But not until it's on the market and we have data on the first 1,000 procedures (as we have with NA) will we realty know. So far we have, what, maybe 75 subjects total?

No kidding Jim, the expansion of NA would drive the price of CI down due to simple market forces. NA has the potential to exponentially increase the supply of the non-sergical option.

I think what's gong on here is that Auxilium is banking on the fact that most CHS are loathe to cut what they can't see and continue to resists NA in spite of Eaton's presentation to the ASSH last year. It looks like their unfounded fear could keep the cost of entry level medical intervention quite high, which is a shame. On the other hand, had NA gone bonkers in the US, Auxilium might find the cost to get Collegenase through the FDA unjustifiable. I know you have doubts that they are serious in the first place.

The term "collagenase" essentially means a substance that dissolves collagen. There are many forms of collagen and my understanding is that AA4500 is somewhat specific in the type(s) of collagen it attacks. Nerves aren't composed of collagen. Beyond that, I'm just speculating.

Remember that the marketing of collagenase to investors (not patients) has been going on for something like 12 years now - I've lost track. For most of that time NA was performed only by a few European doctors, at least some of whom were rheumatologists rather than surgeons. So it was easy to dismiss NA as something that would never be seen in the American market.

Somewhat surprisingly, NA now has presence in the US, which may make things more difficult for Auxilium, and if so they will not be eager to point that out in their presentations to investors. If ultimately AA4500 isn't sufficiently profitable due to competition from NA, it may never be marketed. That would be very unfortunate for the many people with Lederhose, frozen shoulder and Peyronie's, who might be greatly helped by AA4500.

I guess that's one of the concerns with collagenase that it might attack the necessary collagen in joints and thus aggrevate joint pain. Hopefully the trials will clarify this.

Wolfgang

Quote:

---

Hello again
I must apoligise for ad-libing slightly. I was not actually told that it would attack nurves or tendons by my surgeon. That was speculation on my part. What I was told by the surgeon is that it was a non-specific treatment (that might actually mean non specific to diseased tissue). After reading your responses my guess at what the surgeon was meaning is that your hand contains diseased collegen tissue and non-disease collegen tissue. The injection cannot distuguish between the two, but surgery can.

Chris

---