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Auxilium halts drug trials to look into manufacturing issue

By Emilie Reymond, 11-Dec-2006

Related topics: Contract services (outsourcing), Processing equipment, Processing

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 Cobra, to produce another batch if needed.

 

AA4500 is an injectable enzyme that Auxilim is developing to treat Dupuytren's contracture, a disabling and recurring condition in which the joints in the hand contract, impairing patients' ability to straighten and move their fingers, and that can cause fingers to curl.

 

The current treatment for the condition is surgery but the main disadvantages are the significant chance for the condition to come back and the risk of damaging certain nerves during surgery.

 

The AA4500 clinical trial material is a cGMP batch produced by Althea Technologies, Auxilium's contract manufacturer of clinical supplies, and was being used in both of its current Dupuytrens' clinical trials.

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