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Author Topic: PAG Formation and correspondence with Auxilium Pharmaceuticals  (Read 7207 times)

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Larry H

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PAG Formation and correspondence with Auxilium Pharmaceuticals
« on: November 12, 2005, 02:21:55 PM »

The PAG is starting it's initial operation in three areas. First we will be contacting several top Peyronies Disease urologists to discuss a couple of issues of importance. Any information of interest from these contacts will be posted here.

Second, we will contact Auxilium Pharmaceuticals to get the current status of their research into AA4500. Our letter to them will be posted here next week, as will their reply.

Third we will be exploring the Leriche Technique and the reason this procedure has not gained traction in the U.S.

Information gained from these initial contacts will be used to set up a program of action into the area of awareness and Peyronies Disease advocacy. We will not be seeking to recruit patient advocates until a formal plan of action is in place. Of course any suggestions or questions are welcome at any time and can be posted under the "Awareness" topic on the forum.

Barry Farley/Larry Holcombe
Directors, PAG
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Larry H

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Letter to Auxilium Pharmaceutricals and Follow Up
« Reply #1 on: November 19, 2005, 12:27:20 PM »

Below is a letter sent to Auxilium asking for current info into research and development of AA4500.

Larry



Irvin L. Holcombe
44 Quinton Oaks Lane
Callao, Virginia 22435


November 19, 2005

Auxilium Pharmaceuticals, Inc.
40 Valley Stream Parkway
Malvern, PA 19355

Gentlemen:

I am the co-director of the Peyronie’s Advocacy Group (PAG), a part of the Peyronie’s Disease Patient Discussion Forum (PDPDF) www.peyroniesforum.net . The PAG is a grass roots effort to enlist Peyronie’s patients to become patient advocates and advance Peyronie’s awareness within the medical/urological community, the pharmaceutical community, and the general population.

There is much interest in the development of AA4500 within the Peyronie’s patient community as indicated by many posts on the forum. I am writing to ask for your response as to the current status of your research into the development of this treatment.

Although Peyronie’s Disease is considered by many to be a rare disease, and is officially considered an orphan disease, my own research and that of many others indicates that it is anything but rare. A strong case can be made that the disease affects as many as 10% of the male population in the US alone. The problem in understanding the true numbers is that Peyronie’s continues to be a closet disease, and the majority of men with Peyronies Disease conceal their condition because of its very personal nature. The disease robs the patient of his manhood, and no man wants that exposed.

Peyronie’s is a hideous disease that destroys lives, marriages, and families. Many of those that have never been touched by the disease don’t know that such a condition exists.  Others that are aware of the condition consider it to be nothing more than an irritant, and unfortunately there are many urologists who share this feeling. There are even a few people that out of ignorance find the disease humorous. One only needs to read the many posts on the forum to get a flavor of the devastation this disease imparts on the patient and his family.

The disease is thought to affect primarily older men, but there are far too many in their twenties and thirties who post after being diagnosed with Peyronies Disease. We see posts from wives begging for help because their husbands are in denial, or have shut them out of their lives.

There is no question that if Auxilium developed a treatment that improved the condition, and it became public knowledge, there would be millions of men on the phone to their doctors seeking the treatment. We understand the costs involved in the research and development of new drugs and treatments, and we understand that there must be a reasonable chance for these costs to result in a profitable product. We also believe that the true numbers are being grossly underestimated. This has caused research and development of improved treatments to progress at a snails pace. One of our goals with PAG is to more accurately identify the true number of men who suffer with Peyronie’s.

We look forward to your reply, and please feel free to visit our website. In addition we welcome any input or advice you care to offer that may help with our efforts.

Sincerely,



Larry Holcombe
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Larry H

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Auxilium Follow Up
« Reply #2 on: January 03, 2006, 01:54:47 PM »

As of today I have not received a reply to my request for an update on the progress with AA4500 as a treatment for Peyronie's disease. This is unfortunate and disappointing, but not totally unexpected in light of some information on the campany from various sources. It does seem that the company would respond to a group of patients that are all potential users of the drug, and it would make sense from the standpoint of good investor relations.

We are left to conjecture what impact the news that they are developing AA4500 as a treatment for frozen shoulder syndrome will make on the progress of the drug as a treatment for peyronie's.

I will keep all posted on any new developments in this matter.

Larry
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phil

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Re: Auxilium Follow Up
« Reply #3 on: January 03, 2006, 11:22:29 PM »

Larry,

Is there any other collagenase on the market?  Maybe for scar repair etc?

Thanks,

Phil
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hopeful

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Re: Auxilium Follow Up
« Reply #4 on: January 10, 2006, 06:29:33 AM »

I was contacted last week by someone regarding a clinical trial that they are going to do with 20 doctors.. does anyone know about this??/ I will send you my contact info...

Hopeful
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Larry H

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Re: Auxilium Follow Up
« Reply #5 on: January 10, 2006, 06:13:55 PM »

Hopeful,

There has been talk of trials using a combo of the VED and topical verapimil or intralesional verapamil. A NPO foundation started by the owner of Augusta Medical the original maker of the ErectAid VED, I believe, is involved and there will be a number of doctors conducting the trials around the country. My guess this is what you are speaking of, as I think it is just getting started.

Larry
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Barry

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Re: Auxilium Follow Up
« Reply #6 on: March 24, 2006, 12:58:49 AM »

Hopeful,

Quote
"I was contacted last week by someone regarding a clinical trial that they are going to do with 20 doctors.. does anyone know about this??/ I will send you my contact info..."

Above is the statement that you made in Jan on the 10th, do you have any follow up info for us? Thanks in advance.

Barry
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hopeful

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Re: Auxilium Follow Up
« Reply #7 on: March 25, 2006, 04:54:20 PM »

[Barry,
I have not heard a word from anyone- however- you need to read this-as this is a response to a post regarding the needless injection- I believe it is under alternative or verapimil studies??-

After reading this- you can understand why I am not to anxious to get a needle stuck in my penis-

Randy,
 
 In answer to your Post, here are a few facts:
 
1. A needle is known to increase trauma to the scar tissue and the more needle you jab into the penis and into the affected area , the worse things get. I is like pouring gasoline on a fire.
 
2.. There is a big difference between a needle syringe injected into the Penis and our  needle-free injector used for a Penis injection. Essentially ,our needle-free injector is a very tiny liquid needle moving at supersonic speed. The stream of drug has the diameter of less than 10% of a small needle syringe. Therefore the trasuma to tissue is less than 1/10th that of the smallest guage needle syringe. We have studidied this in diabetics and found no scar tissue after thousands of shots with needle-free.
 
3.  The Device can be equipped with a variable power source that allows it to pinpoint the depth of penetration. We can target about 12 different depths.
 


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ComeBacKid

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Re: Auxilium Follow Up
« Reply #8 on: May 25, 2006, 04:16:57 AM »

Larry,

What can we do to help get the attention of Auxillum or speed up this FDA process?  Is there anything at all that we can do?  What can we do to help in advocacy and what not?

ComeBackid
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hopeful

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Re: Auxilium Follow Up
« Reply #9 on: May 26, 2006, 07:48:12 AM »

I have heard nothing- I put the INJEX company in touch with them- and they are still stalling???__
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Larry H

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VED / Verapamil Trials
« Reply #10 on: May 27, 2006, 05:51:45 PM »

The VED/Verapamil trials are underway according to my urologist this past Thursday. From what I understand Dr. Levine is one of the uros involved. I'm not sure at this time if it is with IV or TV or both. I have an appointment at my uros office in July to go over the Augusta VED with the Augusta rep and will find out more on the subject at that time.

Note to ComeBackid:

I got your message and will be in touch shortly.

Larry
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ComeBacKid

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Re: Auxilium Follow Up
« Reply #11 on: May 30, 2006, 05:29:00 PM »

Guys,

I talked to a Dr. Carrol in Orlando, Florida that prescribed me my IONO machine.  He said he knows Dr. Levine in Chicago and said he was doing something with IONO verapamil and VED's, the way Dr. Carroll described it to me was that you use the IONO to drive the verapamil in and soften the plaque, then you use the VED to remold your penis over time to straighten it out.  I think Dr. Levine may currently be doing some experimentation with this.  Dr. Carroll told me that a lot of his patients see results, and that almost all see at least small results from the IONO only if it is a 5 or 10 degree improvment.  Although he did say there are a few that just don't respond at all.  He was very knowledgable and sounded very credible.  We should see if we can add him onto the forum.

ComeBackid
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tmentor

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Upcoming educational presentation
« Reply #12 on: June 03, 2006, 07:40:40 AM »

Hello everyone!
I would like to inform members and guests of this site about an upcoming presentation in Chicago.  "Straight Talk about Peyronie's and Erectile Dysfunction" will be given by Dr. Laurence Levine at Rush University Medical Center on Wednesday, July 26th, 2006 @ 6:00 p.m.   RSVPs should be left with Trent @ 1-800-525-8773 ext 5725     Thank you and hope you can attend!
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ComeBacKid

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Auxilium Pharmaceuticals Reply to our Letter?
« Reply #13 on: June 16, 2006, 01:16:06 AM »

Does any of the senior members or administrators know if Auxillium ever replied to Larry in regards to this letter, and if so what information did they share on the status of their drug?  This letter was sent in November and now here it is in mid June and some people have reported Auxillium still hasn't even begun the trials and is still working on the protocol!  ???

ComeBackid


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Joshua

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Re: Letter to Auxilium Pharmaceuticals
« Reply #14 on: June 16, 2006, 08:48:15 AM »

ComeBackid,
I would assume they simply did not answer otherwise Larry would have certainly posted an update.
Joshua
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Barry

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Re: Letter to Auxilium Pharmaceuticals
« Reply #15 on: June 18, 2006, 05:42:54 AM »

Guys,
The last time I spoke to Larry he said that Auxillium had still not gotten back to him. As much as this administration  would like to hear from them I don't believe "IMHO" that the PDS will establish any open communication with this company. I further believe that the reason is a conflict of interest.

I do however offer Auxillium the opportunity to an open dialouge at their will. The PDS exists for the good of the people and closed door policies serve no one. 

Barry Farley
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j

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Re: Letter to Auxilium Pharmaceuticals
« Reply #16 on: June 18, 2006, 04:36:40 PM »

I don't think it wouldn't matter what they said, anyway.

They couldn't really disclose anything other than what's already in the SEC filings and stockholder presentations.  And that things are going well, the trials should be starting soon and Auxilium is solidly behind the product. Same things you would have heard from BSTC and Auxilium every year since '96.

This doesn't mean that AA4500 isn't going to happen, or that it will take longer than their current target timeframe of 2009, or that it might not become available sooner, to some extent. It just means that no one at Auxilium would tell us what's really happening on the inside. It is after all a publicly traded company.

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Barry

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Re: Letter to Auxilium Pharmaceuticals
« Reply #17 on: June 19, 2006, 06:08:08 PM »

J,
I certainly hope that you don’t presume that Larry or I are so pompous as to expect “Inside” information from Auxilium. What we did hope for was a professional courtesy response from them containing the basics of information for our membership to read. The PDS is a viable, recognized organization within the Peyronies Disease community well deserving a reply. Lacking such a reply just may imply that the PDS is a nuisance and/or unworthy of such a request. This is unacceptable to me.

You of all people, a man who has contributed so much to the PDS and our common cause should recognize that the Letter to Auxilium from Larry was BLOWN OFF, period. Much more could be said about Auxilium and their known affiliates who have no problem getting the time of day from them. But that’s another story for another time.   

Furthermore, I have serious doubts that more than a handful of our membership knows how to access the SEC (Securities and Exchange Commission), or negotiate through it.

Barry
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ComeBacKid

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Re: Letter to Auxilium Pharmaceuticals
« Reply #18 on: June 19, 2006, 06:11:51 PM »

I feel like we have been blown off.  Our organization is growing and will continue to grow into a powerful force in the Peyronies Disease community.  We try not only the traditional treatments, but the alternative ones as well, giving us the edge to the medical community.  How many minutes of Auxillium's day would it really take to respond with a simple letter to our administrators.  We are their future customers if they ever do come out with the product.  To ignore our letter is like saying we don't really have the time for you, or don't want to talk to you, but they will surely want us to buy their product in the future.  I am left feeling like they dissed us, or maybe they don't really plan on ever having an effective treatment for peyronies disease and don't know what to tell us.

ComeBackid
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j

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agreed
« Reply #19 on: June 19, 2006, 08:40:18 PM »

I agree.  They should at leat have replied with a polite letter thanking you for your interest in their company, expressing some empathy and - if nothing else - repeating what they've said in their investor presentations and other public statements. 


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SteveW

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Re: Letter to Auxilium Pharmaceuticals
« Reply #20 on: June 19, 2006, 08:55:30 PM »

ComeBackid,
you were, I am afraid, probably correct.  We were most likely "dissed."  They have figured out the monetary returns based on the projected number of "customers."  And the numbers may not be in our favor.  It's all about the money.  And even if they are pursuing research in "our" realm right now, their focus and energy is probably more, at least at the moment about raising research $$$ and their stock price than our d*cks.
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It takes guts to deal with Peyronies Disease.  Almost a 90 degree curve, hourglass effect, VI series & lots of ??

Larry H

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Re: Auxilium Thoughts
« Reply #21 on: July 12, 2006, 02:15:17 PM »

Unfortunately, I have not received a reply from Auxilium. Perhaps their involvement with the APDA played some role in their lack of response, I don't know. It does seem unprofessional, especially for a publicly traded company.

Larry
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Blink

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Re: Letter to Auxilium Pharmaceuticals
« Reply #22 on: July 12, 2006, 07:52:26 PM »

Larry, did you read my post? I got in touch with a guy from Auxilium and he is putting together a list of people to take part in testing to begin nationwide in a couple of months. They are looking for people in and around the test areas. I do not know where these ares are yet, but Gary said that he would give me a heads up when it was time. Blink
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ComeBacKid

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Re: Letter to Auxilium Pharmaceuticals
« Reply #23 on: July 13, 2006, 05:44:52 PM »

Larry,

"Perhaps their involvement with the APDA played some role in their lack of response," 

The APDA shouldn't play a role in their lack of response, they are a publicly traded company, anyone can buy stock in them, does APDA own all the stock?  I just can't believe the way the Peyronies Disease community has become political and people have put their own self interests ahead of others.  I'm not going to point the finger at anyone in particular, but I can't believe people can't come together for the sake of their own penises!  As we continue to grow it will be hard for any companies seeking a cure for peyronies to ignore our organization, we are their MARKET! 

Larry, if I were you I'd resend a letter saying several members in our organization expressed disappointment with their failure to respond to us, and that we have many members who are interested in their product... etc... 

ComeBackid
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Larry H

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Re: Blink and ComeBackid-Letter to Auxilium Pharmaceuticals
« Reply #24 on: July 13, 2006, 06:15:49 PM »

Blink:

No I did not see that, Ive been away from the forum for a couple of months because of personal issues and it's taking me some time to catch up. However, that sounds positive.

ComeBackid:

Auxilium has given the APDA a funding grant. Since some well known Peyronies Disease urologists sit on the APDA board, it may be that Auxilium views the PDS as being in competition with the APDA and made a decision not to have any public association with us. Of course the idea of competion is ridiculous since we are just two associations seeking the same goal. However, that may not be how Auxilium views it. The doctors are very important to Auxilium, they would not want to do anything that may be viewed as being out of line by the doctors, and that's understandable. That's all I was saying and it's pure speculation on my part.

Larry
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ComeBacKid

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Re: Letter to Auxilium Pharmaceuticals
« Reply #25 on: July 13, 2006, 07:29:53 PM »

Larry,

I totally understand and agree with your point.  My point is that its kind of self defeating to have two different peyronies groups.  I don't want to fuel a debate on the APDA vs our organization cause that would be counter productive. In my view, a lot of the people in this organization are registered on the APDA membership list.  Our organization is member driven, while they have a board over at the APDA.  I just think its kind of sad that we are competing and that Auxillium would pander to them cause they have doctors on their board.  Perhaps, I"m just disappointed we received no response from Auxillium, I let myself get to excited over a new product that might cure me.

ComeBackid
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