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Pharmaxis’ Orphan Drug Bronchitol And The FDA Advisory Committee Meeting

January 29, 2013

As reported yesterday by the Orphan Druganaut Blog, this Wednesday, January 30, 2013, the FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting will discuss the New Drug Application (NDA) 202049, for mannitol inhalation powder (proposed trade name Bronchitol) for oral inhalation sponsored by Pharmaxis.  Bronchitol’s proposed indication  is for the treatment of Cystic Fibrosis (CF) patients aged 6 years and older.

Pharmaxis is an Australian pharmaceutical company specializing in undertreated respiratory diseases. Bronchitol has Orphan Drug Designation in the US, Europe, and Australia. It is approved for marketing in Australia and throughout the European Union. Bronchitol was discovered and developed in Australia and is currently on the list of Australia’s Pharmaceutical Benefits Scheme (PBS) for CF.

Pharmaxis requests a trading halt of its securities until the announcement of the PADAC review decision for Bronchitol. The meeting materials are released on the FDA website on Monday, 01.28.13. It is from these background meeting materials that one can get a glimpse into what the FDA PADAC members are thinking in advance of the actual meeting. Pharmaxis cannot comment on the meeting materials until the meeting is finished. Pharmaxis will probably make an announcement as to the decision on Bronchitol on Thursday, 01.31.13.

The following is the Internet Buzz on the upcoming PADAC meeting :

***  1)  BioCentury.com article titled, “FDA reviewers question Bronchitol efficacy”

2)  TheAustralian.com.au article titled, “D-Day as Pharmaxis pushes new drug in US”

3)   Reuters via xe.com article titled, “FDA staff questions efficacy data on Pharmaxis’ CF drug”.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved

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