ELTVILLE, Germany, April 27, 2012 /PRNewswire/ --
Pharmaceutical company Pharmaxis (ASX: PXS) is pleased to
announce it has received Marketing Authorisation for Bronchitol
from the European Commission. The licence allows the new cystic
fibrosis treatment to be made available for patients aged 18 and
above as an add-on therapy to the best standard of care in 29
European countries.
Pharmaxis CEO Dr Alan Robertson
said, "This is a very significant event, which means that patients
living with cystic fibrosis in Europe will now be able to receive the proven
clinical benefits of Bronchitol."
CF patients in Germany and the
UK, where there is less requirement for pricing and reimbursement
approval before launch, will be first to benefit from Bronchitol.
These two countries make up 40% of the European market by value.
Pharmaxis expects stock to be available for sale in Europe by June
1st ahead of the official launch of the product,
which will take place at the European Cystic Fibrosis Conference in
Dublin from 6th - 9th June
2012.
Bronchitol has been developed to help clear the airways of
people with the world's most common, life limiting genetic disease,
cystic fibrosis. In two large Phase 3 clinical trials, Bronchitol
improved mucus clearance, improved lung function and reduced
infectious episodes compared to control when patients were treated
for 6 months.
Dr Robertson said, "We have built considerable momentum around
Bronchitol in recent months with the German and UK sales teams
fully recruited and trained."
"Pharmaxis has now secured three drug approvals in the world's
largest pharmaceutical markets: the lung function test Aridol in
Europe and the US and now approval
for Bronchitol in Europe and
Australia. This is a credit not
only to the company but also the investigators and patients
throughout the world who have taken part in our clinical programs,"
Dr Robertson said.
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), PXS25 for the
treatment of lung fibrosis and ASM8 and PXS4159 for asthma.
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 effective in treating patients with 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.
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.
PRESS CONTACT:
UK:
Chandler Chicco Agency
Samina Qutub
phone: +44(0)20-7632-1816
email: s.qutub@cca-uk.com
