Proactive Investors - Run By Investors For Investors

Pharmaxis welcomes US FDA committee’s recommendation on use of Bronchitol in CF

If Bronchitol is approved later this year, Pharmaxis is down to receive US$10 million.
US flag staked in grass
Pharmaxis would manufacture and exclusively supply Bronchitol for the US market

Pharmaxis Ltd (ASX:PXS) (FRA:UUD) (OTCMKTS:PXSLY) US licensee Chiesi Farmaceutici S.p.A. has received a positive US Food and Drug Administration advisory committee recommendation for use of the inhaled powder Bronchitol in adult patients with cystic fibrosis (CF).

The recommendation is a positive milestone for international commercialisation of the drug the Australian company developed.

Overnight in Washington, nine of the 16-member Pulmonary‐Allergy Drugs Advisory Committee (PADAC) voted yes to the question : “Is the benefit‐risk profile adequate to support approval of DPM (dry powder mannitol) for the proposed indication of the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies?”

PADAC is responsible for reviewing and evaluating safety and effectiveness data for proposed new products for treating pulmonary disease and conditions with allergic and/or immunologic mechanisms and makes recommendations to the US FDA.

READ: Pharmaxis sees progress in Boehringer Ingelheim’s clinical trial in patients with NASH

Pharmaxis chief executive officer Gary Phillips called the committee’s vote for a recommendation “very encouraging” while noting it was not binding on regulators.

Phillips highlighted the company’s next steps and expected timetable in a market release, saying: “Pharmaxis will continue to support Chiesi to work with the FDA to bring Bronchitol to patients in the US.

“We expect the FDA to make its final decision by mid‐year.”

If the FDA approves the drug for marketing, its manufacturer and exclusive supplier Pharmaxis is set to receive a US$10 million payment on the product’s commercial launch in the US market.

US market approval has long been a goal for the dry-powder therapeutic which studies have shown helps CF patients clear mucus from their lungs and improve their lung function.

Three large-scale global clinical trials of Bronchitol have been undertaken by Pharmaxis.

The company’s efforts have resulted in regulatory approvals in a variety of geographic markets, and marketing in Europe, Russia, Australia and a number of other countries.

 

View full PXS profile View Profile

Pharmaxis Ltd Timeline

Related Articles

A paper rocket is ready to launch on a surgeon's scissors
March 29 2019
The company hopes to improve its share price with ADAPT technology successes.
copd radiograph
April 02 2019
City broker Peel Hunt reckons the recent approvals “support the top-line forecasts in our model that should see Circassia achieve EBITDA positivity in 2020”
picture of a knee
May 21 2019
We take a closer look at Collagen Solutions, which received third-party validation of its business model in the form of outside investment from a blue-chip US agriculture company

© Proactive Investors 2019

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use