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Auxilium Pharmaceuticals Inc. (AUXL)
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01/31/2007 16:46
Wanker 
01/31/2007 16:46
Wanker 
Auxilium Pharmaceuticals Inc. (AUXL)

I follow AUXL in the stock reports. Why? Auxilium Pharmaceuticals, Inc. focuses on developing and marketing specialty biopharmaceutical products to urologists, endocrinologists, orthopedists, and select primary care physicians primarily in the United States. It markets Testim 1%, a topical testosterone gel, for the treatment of hypogonadism through its person sales and marketing team. The company has four projects in clinical development, which primarily include AA4500 and AA4010. AA4500, an injectable enzyme, has completed Phase II of development for the treatment of Dupuytren's contracture and is in Phase II of development for the treatment of Peyronie's disease and Frozen Shoulder Syndrome (Adhesive Capsulitis). Auxilium?s transmucosal film product candidate for the treatment of overactive bladder, AA4010, is in Phase I of development. The company also has two pain products using its transmucosal film delivery system in pre-clinical development. In addition, it has rights to six pain products, and products for hormone replacement and urologic disease using its transmucosal film delivery system, and options to all indications using AA4500 for non-topical formulations. Auxilium, under a license and distribution agreement with Ipsen Farmaceutica, B.V., also offers its products in markets of Belgium, Denmark, Finland, Germany, Ireland, Netherlands, Spain, Sweden, and the United Kingdom. The company was founded in 1999 and is headquartered in Malvern, Pennsylvania.

Auxilium Pharmaceuticals Inc.
40 Valley Stream Parkway
Malvern, PA 19355
Phone: 484-321-5900
Fax: 484-321-5999
Web Site: http://www.auxilium.com

I bought some AUXL stock. It rose from $8 to $14 in six months. By being a shareholder I hope to get some insight regarding the results of their AA500 testing and testing results. Stock reports and company profiles may be our best source of information about collengase (AA500).

02/01/2007 15:24
jonno 
02/01/2007 15:24
jonno 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

Found this press release from AUXL:
MALVERN, Pa., Dec. 6 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that it has temporarily suspended the dosing of patients in the Company's ongoing phase III trials for AA4500 for the treatment of Dupuytren's contracture in response to a visual appearance failure of the lyophilized material in some vials of AA4500 for use in the clinical trials. The Company is conducting an investigation to determine the root cause of this failure and believes that it is likely related to the higher than expected moisture content within the vial. Based on tests conducted, the Company has excluded container closure as a cause and believes that the issue is related to the lyophilization process and/or equipment. The issue was identified as part of routine ongoing stability testing. The Company will hold a conference call to discuss this matter on December 7, 2006 at 9:00 a.m. Eastern Time.

The Company stated that it has not received any reports of adverse reactions from the ongoing phase III trials and that the clinical trial investigators would continue to monitor patients already dosed in accordance with the trial protocols.

"While we are disappointed by this development, we believe this is the right thing to do both for patients and for the Company, who have a common interest in successfully developing non-surgical therapies to effectively treat Dupuytren's contracture," said Mr. Armando Anido, Chief Executive Officer and President. "We know that the manufacture of biologics is complex and our team of experts will endeavor to complete the root cause investigation as soon as possible in order to implement corrective actions so that we can resume the phase III trials."

Both the U.S. and ex-U.S. studies are double-blind, randomized, placebo controlled studies of AA4500. The U.S. study is designed to enroll more than 200 patients at up to 15 sites, and the ex-U.S. study is designed to enroll up to 60 patients at sites in Australia and Switzerland.

02/01/2007 20:52
jim_h 
02/01/2007 20:52
jim_h 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

Yes it's been almost 2 months now since the trials stopped. According to the Motely Fool (a popular stock market information source) the stock is now being heavily "shorted", which means that many investors think it's overvalued and soon to fall.

This doesn't mean the end, problems are to be expected. But Auxilum hasn't said anything publicly about the trials in quite a while now. Has anyone heard anything?

02/09/2007 16:15
Wanker 
02/09/2007 16:15
Wanker 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

I just took a look at Auxilium's stock. Last March it traded at $6. Today it trades over $14. I take hope from this stellar performance. Perhaps collegenase may be on the horizon.

02/15/2007 12:56
Donald 
02/15/2007 12:56
Donald 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

Here is an extract of today's Auxilium press release

-----------------------------------------------------------------------------------
Auxilium expects to:

- resume the phase III clinical trials for AA4500 for the treatment of
Dupuytren's contracture in the fourth quarter of 2007;
-----------------------------------------------------------------------------------

02/15/2007 17:30
jim_h 
02/15/2007 17:30
jim_h 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

So they've lost a year, best case. The current Phase III trial is dead and they're essentially announcing their intent to restart it at the end of the year. We're right where we were 10 years ago.

02/15/2007 17:49
Randy_H 
02/15/2007 17:49
Randy_H 

Re: Auxilium Pharmaceuticals Inc. (AUXL)

Looks like the disruption of the flow of Collegenase has put approval back another year. Get used to it. This has been gong on now for years. Yes, there is still hope, but don't hold your breath. Meanwhile NA has been shown to do nearly exactly the same thing and Eaton believes that a significant majority of all new patients who need a procedure can use it for the rest of their lives to maintain their disease. I'm having my teeth deep cleaned today and two other times this month. I think maybe I'd rather have NA. :-)

02/15/2007 19:07
jim_h 
02/15/2007 19:07
jim_h 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

Unfortunately NA isn't a treatment for Lederhose or Peyronie's. So until Auxilium decides to complete the trials and market AA4500, those people have nothing.


02/15/2007 22:22
klshirk 
02/15/2007 22:22
klshirk 
Re: Auxilium Pharmaceuticals Inc. (AUXL)

Dear Jim

I not only have the DC, LD, and am developing frozen shoulder...just by the way things are playing out I must say that I am happy to not be a guy...I know where my track record so far would lead me.

Kristine

02/16/2007 20:44
Randy_H 
02/16/2007 20:44
Randy_H 

Re: Auxilium Pharmaceuticals Inc. (AUXL)

Kristine,

Get on top of the Frozen Shoulder right away if you haven't already. It only gets worse until you get into therapy. The sooner the better. My therapy and recovery from FS was so painful that I would have talked and given up the location of the WMD's :-) Jack Bower had nothing on this PT. They have no mercy so catch this thing *early*.

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pase-restricted   contracture   Collagenase   clinical   Dupuytren   Wolfgang-learning   placebo-treated   frozenshoulder   PRNewswire-FirstCall   Pharmaceuticals   placebo-controlled   metacarpophalangeal   company   patients   Shoulder   biopharmaceutical   Auxilium   development   endocrinologists   treatment