SYDNEY, Australia, June 16 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced the appointment of IDIS Limited to manage and provide eligible patients worldwide with access to Bronchitol through a Named Patient Program.
The program will allow patients who are unable to participate in current Pharmaxis clinical trials but who are considered by their physician to be suffering from a clinical condition for which no satisfactory authorised alternative exists, to receive access to Bronchitol on a named patient basis.
The program will establish a common approach to the use and distribution of Bronchitol and the eligibility of patients.
"IDIS is a partner of choice for major global pharmaceutical companies in providing ethical named patient access to medicines in countries where the product is yet to be authorised," said Pharmaxis CEO Alan Robertson.
"Bronchitol will be made available to people with a chronically or seriously debilitating, or life threatening condition who cannot be treated satisfactorily by an authorized medicine.
"IDIS manages Named Patient Programs in over 100 countries, and is recognised for its rigorous capture of pharmacovigilance information and quality doctor education programs.
"We are pleased to be able to offer the option of Bronchitol to physicians with patients in urgent need," said Dr Robertson.
Bronchitol is in final clinical trials for the treatment of the chronic lung conditions cystic fibrosis and bronchiectasis. The U.S. Food and Drug Administration has granted Bronchitol fast track status and it is designated as an orphan drug in the U.S. and Europe.
The statements contained in this media release that are not purely
historical are forward-looking statements within the meaning of Section 21E
of the Securities Exchange Act of 1934, as amended. Forward-looking
statements in this media release include statements regarding our
expectations, beliefs, hopes, goals, intentions, initiatives or strategies,
including statements regarding the potential for Aridol and/or Bronchitol.
All forward-looking statements included in this media release are based
upon information available to us as of the date hereof, and we assume no
obligation to update any such forward-looking statement as a result of new
information, future events or otherwise. We cannot guarantee that any
product candidate will receive FDA or other regulatory approval or that we
will seek any such approval. Factors that could cause or contribute to such
differences include, but are not limited to, factors discussed in the "Risk
Factors and Other Uncertainties" section of our Form 20-F lodged with the
U.S. Securities and Exchange Commission.
Chief Executive Officer
Further information on the Program is available from IDIS Limited:
|SOURCE Pharmaxis Ltd|
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