SYDNEY, October 26, 2011 /PRNewswire/ --
Pharmaceutical company Pharmaxis (ASX: PXS) today announced the
Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion recommending the granting of a Marketing
Authorisation for Bronchitol, clearing the way for the product to
be used in Europe "for the
treatment of cystic fibrosis in adults as an add-on therapy to best
standard of care."
Pharmaxis expects the European Commission to confirm this
opinion and grant the Marketing Authorisation for Bronchitol in
January 2012.
Pharmaxis CEO Dr Alan Robertson
welcomed the decision saying, "This outcome from the CHMP meeting
is an important milestone for the company. It is good
news for the cystic fibrosis (CF) community which has supported us
throughout the development of Bronchitol. As the life
expectancy of CF patients has lengthened, the size of the adult
population in Europe has
increased. Bronchitol will be used for CF patients aged 18
and above, which represents about two thirds of all patients who
could potentially benefit from the drug. Pharmaxis will undertake a
short term clinical trial in children (age 6-17) with a view to
extending the license to this age group."
"Bronchitol is a drug which was discovered and developed in
Australia. It is approved
for marketing in Australia and is
now set to become available throughout the 27 countries of the
European Union. This outcome represents the culmination of a
great deal of work by many people."
"Pharmaxis will move quickly to commercialise Bronchitol in
Europe. We have finalised
our supply and logistics arrangements and advanced launch
preparations and pricing applications with our marketing partner,
Quintiles. The awareness of Bronchitol's clinical data
amongst CF clinicians has increased through publications and
presentations at scientific conferences. European clinicians
provided valuable support to the CHMP decision and are looking
forward to Pharmaxis bringing this new therapeutic treatment option
to their patients in the near future." Dr Robertson said.
Professor Stuart Elborn,
President of the European Cystic Fibrosis Society, stated,
"Life expectancy in cystic fibrosis is improving but there
remains an urgent need for new therapies which can improve lung
function and reduce exacerbations. Bronchitol increases mucociliary
clearance and will be the first approved therapy in Europe with this mechanism of action and has
been shown to improve both lung function and reduce exacerbations
when added to standard medications in use today. I welcome
this decision by the CHMP."
Robert J. Beall, Ph.D, President
and CEO of the American Cystic Fibrosis Foundation, said, "The
Cystic Fibrosis Foundation is delighted to see an important new CF
medicine being made available to patients in Europe. It takes
a lot of dedication from industry and the CF community to develop a
drug to this point. We are proud to have played a part in
this process through our clinical trial group and look forward to
Bronchitol being submitted to the FDA early next year."
Bronchitol's approval for the treatment of cystic fibrosis
patients in Australia and the
European Marketing Application are based on the results of two
Phase 3 clinical trials involving more than 600 people and
conducted in 95 centres throughout the world.
About Pharmaxis
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical
company involved in the research, development and commercialization
of therapeutic products for chronic respiratory disorders. Its
product Aridol® for the assessment of asthma is launched in a
number of key markets. Its development pipeline of products
includes: Bronchitol for cystic fibrosis, bronchiectasis and
chronic obstructive pulmonary disease (COPD), ASM8 for asthma,
PXS25 for idiopathic pulmonary fibrosis and a new oxidase inhibitor
for lung disease. Pharmaxis is listed on the Australian
Securities Exchange (symbol PXS). The company is headquartered in
Sydney at its TGA-approved
manufacturing facilities. For more information about Pharmaxis, go
to http://www.pharmaxis.com.au or contact Investor Relations on
phone +61 2 9454 7200.
About Bronchitol
Bronchitol has been developed to help clear mucus (a major
source of lung infections), improve lung function and reduce
exacerbations in patients with cystic fibrosis.
Bronchitol is a proprietary formulation of mannitol administered
as a dry powder in a convenient hand-held inhaler. Bronchitol
hydrates the lungs, helps restore normal lung clearance, and allows
patients to clear mucus more effectively. Clinical studies have
shown Bronchitol to be safe, effective, and well tolerated in
treating patients cystic fibrosis.
About Cystic Fibrosis
In a healthy person, there is a constant flow of mucus over the
surfaces of the air passages in the lungs, removing debris and
bacteria. In CF, an inherited disease, a defective gene disrupts
ion transport across the epithelial membrane within cells. In the
lungs, this leads to a depletion of the airway surface liquid that
normally bathes the cilia, and a resultant reduction in mucociliary
clearance. The result is thick, sticky mucus that clogs the lungs,
severely restricting the natural airway-clearing process. It also
increases the potential for bacteria to become trapped and for
inflammation, thus creating an unhealthy lung environment that
leads to life-threatening lung infections.
About the Committee for Medicinal
Products for Human Use (CHMP)
The CHMP meets once a month. The meetings of the CHMP are not
public. Currently, no agendas or minutes of the meetings are
published. After each CHMP meeting, a meeting report and a press
release are published on the Agency's website
(http://www.ema.europa.eu). In addition, summaries of opinions
adopted during each meeting in respect of specific medicines are
published on the Agency's website. These express the opinion of the
CHMP on new marketing application dossiers from pharmaceutical
companies, on referral procedures and on other issues on which the
Committee is required to provide an opinion.
Forward-Looking Statements
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 regulatory
approval or that we will seek any such approval.
