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01/07/2007 23:34
Wanker
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01/07/2007 23:34
Wanker
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AA4500
Auxilium halts drug trials to look into manufacturing issue
by Emilie Reymond
Auxilium slices contract manufacturing deal with Cobra Contract manufacturing news in brief
11/12/2006 - Biotech drugmaker Auxilium has temporarily suspended Phase III clinical trials to investigate a manufacturing problem with its new injectable enzyme batch, which could potentially cost the firm $1m (€750,000).
The company said that during routine stability testing, the lyophilised, or freeze-dried, material in its vials of study drug AA4500 for Dupuytren's disease – a rare finger-joint condition – failed to pass visual tests and Auxilium decided to suspend dosing patients with the drug just a couple of weeks after initiating Phase III trials in the US, Australia and Switzerland.
Auxilium is currently investigating the issue and believes higher-than-expected moisture in the vial could have produced the appearance, after having excluded container closure issues as the problem.
Following the discovery of the problem, the firm said it conducted a 100 per cent inspection of the clinical trials material and concluded that 73 per cent passed the inspection for visual appearance.
“We are not sure if once the trials are resumed we will be able to use the 73 per cent material that passed the inspection. We will have to discuss with the FDA on that,” said Auxilium CEO Armando Aniso during a conference call.
Aniso said that his company notified the Food and Drug Administration (FDA) of the problem and requested a meeting to review the issue and its corrective action plan going forward.
“We expect it will happen in a relatively quick fashion. Once the FDA has the data and information of our corrective action plan, it should normally take around 30 days for the agency to get back to us,” said Aniso.
However, he refused “to speculate on the impact this temporary suspension of dosing will have on the timelines for AA4500.”
So far, the company hasn't received any reports of adverse reactions from the ongoing trials.
The US study is designed to enroll more than 200 patients at up to 15 sites, and the study abroad is designed to enroll up to 60 patients at sites in Australia and Switzerland.
Aniso added that Auxilium now plans to increase the degree of moisture testing of the next batch to demonstrate that acceptable moisture levels have been obtained.
“We believe that we may be able to cure the moisture issue by extending the lyophilisation cycle drying time and modifying the manufacturing equipment to obtain a lower moisture content in the lyophilised material,” he said.
In the worst case scenario, where Auxilium would have to discard the existing batch altogether, this issue could represent a substantial loss for the company as, according to Aniso, the cost of a batch is somewhere around $1m.
On a more positive note, Aniso added there was enough active pharmaceutical ingredients (APIs) available, manufactured by contractor
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01/07/2007 23:37
Wanker
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01/07/2007 23:37
Wanker
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Re: AA4500
I hope you don't mind the long posts. I try to keep up with the lastest news regarding the AA4500 trials.
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04/25/2007 13:08
jim_h
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04/25/2007 13:08
jim_h
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Re: AA4500
There is an abstract of a study done in 1996 which clearly demonstrated that collagenase injections can be used to rupture Dupuytren's cords. Just google on "dupuytren's hurst 1996 collagenase" to find out about it.
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04/25/2007 21:31
jim_h
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04/25/2007 21:31
jim_h
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Re: AA4500
randy_h, if you felt my original post was inappropriate for the forum, I would prefer you just delete it rather than rewriting it. I get a weird feeling seeing a post from 'me' which I didn't actually write.
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04/25/2007 21:59
Randy_H
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04/25/2007 21:59
Randy_H
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Re: AA4500
jim_h
I deleted your first post as you requested. Having done that, your next post didn't make sense any longer as it referred to the post you asked me to delete. I reworded it and then sent you an email asking if you approved. Please repost that item if you will so we can get back on track.
Thanks
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04/26/2007 00:36
jim_h
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04/26/2007 00:36
jim_h
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Re: AA4500
randy_h - I got the email but it was from 'forum-please-do-not-reply@dupuytren-online.info
I replied anyway, but it bounced.
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05/02/2007 14:44
Wanker
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05/02/2007 14:44
Wanker
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Re: AA4500
Auxilium Pharmaceuticals, Inc. Announces First Quarter 2007 Financial Results and Operational Highlights
On Track to Resume AA4500 Phase III Trials in Fourth Quarter 2007 Testim(R) Total Prescriptions Up 38% versus Q1 of 2006 Q1 Net Revenues Up 24% versus Q1 of 2006
MALVERN, Pa., May 1 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced financial results and operational highlights for the quarter ended March 31, 2007. For the first quarter of 2007, Auxilium reported net revenues of $18.4 million compared to net revenues of $14.9 million in the first quarter of 2006.
"Our number one priority continues to be restarting the phase III trials for AA4500 for the treatment of Dupuytren's contracture, and we believe we are on track to resume those trials in the fourth quarter of this year," said Mr. Armando Anido, Chief Executive Officer and President.
"We also are extremely pleased with the strong prescription demand for Testim and believe this is a result of the impact of our expanded sales force. We believe we are on track to achieve net revenues in the range of $88 million to $92 million, our previously announced guidance for 2007."
First Quarter 2007 Highlights:
AA4500:
-- We have completed multiple production runs of the finished dosage form of AA4500 and will continue to collect data at multiple stability time points in preparation of a submission to the U.S. Food and Drug Administration seeking approval to recommence the phase III trials for AA4500 for the treatment of Dupuytren's contracture in the fourth quarter of this year.
-- In February, we announced positive results from the open-label extension of our initial double blind Phase III study of A4500 for the treatment of Dupuytren's contracture. In this study, 88 percent of Metacarpophalangeal (MP) joints and 68 percent of Proximal Interphalangeal (PIP) joints were fully corrected. This open-label extension study provided further support for the efficacy and safety of AA4500 injections in the treatment of Dupuytren's contracture.
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