Regulatory Path for Bronchitol in Bronchiectasis
01 Maggio 2008 - 1:01PM
PR Newswire (US)
SYDNEY, Australia, May 1 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis
(AXS: PSX; Nasdaq: PXSL) today announced that it has agreed with
advice from the U.S. Food and Drug Administration (FDA) on the
design of a pivotal Phase 3 trial of the company's mucus clearing
agent, Bronchitol, in patients with bronchiectasis. The trial is a
randomized, double-blind investigation of Bronchitol twice daily in
approximately 300 adults with bronchiectasis. Participants will be
treated for 52 weeks during which they will be assessed for
reduction in frequency of exacerbations and quality of life. The
trial will be undertaken in Europe and the USA. This trial is the
second Phase III study to be undertaken with Bronchitol in people
with bronchiectasis and follows the completion of a successful
trial reported during the third quarter of 2007. These trials are
expected to form the basis of a marketing application in both the
European Union and the U.S. Recruitment of volunteers will begin
following receipt of the necessary approvals to begin the trial and
is expected to be during the third quarter of 2008. The clinical
trial protocol requires final review by both the U.S. FDA under
their Special Protocol Assessment (SPA) process and the European
Medicines Agency, the EMEA. The SPA process allows for FDA
evaluation of a clinical trial protocol intended to form the
primary basis of an efficacy claim in support of a New Drug
Application, and provides an agreement that the study design,
including trial size, clinical endpoints and/or data analyses are
acceptable to the FDA. Alan Robertson (Pharmaxis CEO) said, "To
ensure that this pivotal trial can start quickly and be completed
efficiently, Pharmaxis has assembled a specific advisory board of
opinion leading physicians in bronchiectasis and employed clinical
and regulatory staff in the US and EU. There are no products
specifically approved for bronchiectasis and Bronchitol remains the
only product currently in the later stages of development for
bronchiectasis. We are determined to make it available to patients
worldwide as soon as possible." Pharmaxis is developing Bronchitol
as a treatment to improve mucus clearance in the lungs of patients
with cystic fibrosis, bronchiectasis and chronic obstructive
pulmonary diseases. Bronchitol is a patented, inhalable dry powder
formulation of mannitol that is administered directly to the lungs
through a convenient, breath activated and easy to use hand held
device. 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. A large Phase III trial expected to form
the basis of a marketing approval for Bronchitol in Europe in
patients with cystic fibrosis is currently actively recruiting.
CONTACT: Alan Robertson - Chief Executive Officer Ph: +61 2 9454
7200 or email Released through: United States: Brandon Lewis, Trout
Group, phone +1 646 378 2915 or email Australia: Virginia Nicholls,
phone +61 417 610 824 or email Forward-Looking Statements 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. DATASOURCE: Pharmaxis Ltd
CONTACT: Alan Robertson, Chief Executive Officer, +61-2-9454-7200,
; In the United States: Brandon Lewis, Trout Group,
+1-646-378-2915, ; In Australia: Virginia Nicholls,
+61-417-610-824, Web site: http://www.pharmaxis.com.au/
http://services.choruscall.com/links/pharmaxis041608.html
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