time frame, page-6

Major meeting tomorrow, it looks like:

From: http://biotechnologynews.net/storyview.asp?storyid=1038990§ionsource=s0

Pharmaxis faces FDA committee tomorrow

PHARMAXIS will arrive at a major moment in its history on Friday when its scientific team faces the FDA’s Pulmonary-Allergy Drugs Advisory Committee Meeting, which is considering the future of the company’s asthma diagnostic product, Aridol.

A positive recommendation by the advisory committee will almost certainly mean the drug is approved for sale in the US – likely making Pharmaxis the first Australian company to take a new drug from development through to approval in the largest drug market in the world.

Pharmaxis chief executive Dr Alan Robertson told BTN the meeting would be a big day for Aridol, but also a “huge day” for Pharmaxis as a company.

He said Pharmaxis had flown three of its Australian staff to the meeting, with three of its US-based staff attending the meeting also.

The committee will consider whether Aridol will be approved for the assessment of bronchial hyper-responsiveness, to aid in the diagnosis of patients over 6 years of age with symptoms of asthma.

Robertson described the meeting as the “biggest production number you could imagine” and said the company expected to know by the weekend whether the advisory committee would vote to recommend the approval of Aridol.

If approved, Aridol will be only the second agent approved by the US Food and Drug Administration for bronchial provocation testing since methacholine chloride (sold as Provocholine) was approved in 1986.

And while Aridol isn’t the main game for Pharmaxis, Robertson said he still believed in the potential of the product.

“Aridol is not the main prize, but I still like the product and I think it will contribute to our earnings over the longer time,” he said.

RBS Morgans biotechnology analyst Scott Power told BTN that, while Aridol was only a small part of his valuation of Pharmaxis, a positive recommendation would certainly bode well for sentiment in the company.

Power said the potential market for Aridol was around $US170 million, though he expected Pharmaxis to capture only a relatively small portion of that in the short term.