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The application is based on a multicentre Phase 3 clinical trial involvingmore than 360 subjects which evaluated the safety and efficacy of Bronchitolfor inhalation in subjects with bronchiectasis. All of the primary efficacyend points were positive and statistically significant, and Bronchitol wasshown to be well tolerated with no serious adverse events attributed totreatment.
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After being accepted for evaluation, the TGA has 255 working days toreview the application lodged by Pharmaxis.
There is currently no approved medication that specifically targets mucusclearance for people suffering from bronchiectasis.
Alan Robertson, Pharmaxis chief executive officer said: "We are delightedto announce this major milestone for Pharmaxis and believe this is animportant development for people living with the incurable lung conditionbronchiectasis. Pharmaxis is dedicated to the development of safe andeffective treatments for airway diseases, and we continue to work closely withregulatory authorities worldwide to bring Bronchitol to patients as quickly aspossible."
It is estimated that more than 600,000 people in the major pharmaceuticalmarkets suffer from bronchiectasis and Pharmaxis expects Bronchitol to be thefirst targeted medication for this patient group in 20 years, addressing animportant medical need. In Australia, it is believed that more than 18,000people live with bronchiectasis and over 70% are moderately or severelyincapacitated by their condition.
Bronchitol is also under development as a twice daily inhalation therapyfor people with cystic fibrosis with two large Phase 3 trials currentlyunderway.
Forward-Looking Statements
The statements contained in this media release that are not purelyhistorical are forward-looking statements within the meaning of Section 21E ofthe Securities Exchange Act of 1934, as amended. Forward-looking statements inthis media release include statements regarding our expectations, beliefs,hopes, goals, intentions, initiatives or strategies, including statementsregarding the potential for Aridol and/or Bronchitol. All forward-lookingstatements included in this media release are based upon information availableto us as of the date hereof, and we assume no obligation to update any suchforward-looking statement as a result of new information, future events orotherwise. We can not guarantee that any product candidate will receive FDA orother regulatory approval or that we will seek any such approval. Factors thatcould cause or contribute to such differences include, but are not limited to,factors discussed in the "Risk Factors and Other Uncertainties" section of ourForm 20-F lodged with the U.S. Securities and Exchange Commission.CONTACT: Alan Robertson - Chief Executive Officer Ph: +61 2 9454 7200 or email [email protected] RELEASED THROUGH: Australia: Felicity Moffatt, phone +61 418 677701 or email [email protected] United States: Brandon Lewis, Trout Group, phone +1 646 378 2915 or email [email protected]
SOURCE Pharmaxis Ltd
