I was just reading the CF NEWS FROM AROUND THE WORLD newsletter that gets e-mailed to me and this confused me. I posted the whole thing so you could read it if you want, but you really don't even need to, just look at the highlighted part. It doesn't seem right to me...
Worldwide Biotech
January 1, 2007
US FAST-TRACKS PHARMAXIS CYSTIC FIBROSIS DRUG.
Pharmaceutical company Pharmaxis (NASDAQ<img src="i/expressions/face-icon-small-tongue.gif" border="0">XSL), Sidney, Australia,has announced
that the US Food and Drug Administration has designated Bronchitol as a
fast-track product for cystic fibrosis.
The FDA fast-tracks the New Drug Application (NDA) process if a therapy can
potentially address an unmet medical need for a life-threatening disease.
Designation as a fast-track product is designed to expedite regulatory review of
the Bronchitol NDA. The FDA and European Medicines Agency have both previously
granted Bronchitol orphan drug status for treating cystic fibrosis.
Pharmaxis chief executive officer Dr Alan Robertson said: "The FDAdecision is
encouraging news for thousands of cystic fibrosis patients. It recognises the
positive clinical data for Bronchitol in treating cystic fibrosis, which is a
lethal inherited condition.
"This designation will speed the process of bringing this potentially
life-saving drug to cystic fibrosis sufferers.
"Phase II studies show Bronchitol significantly improves lung function and
wellbeing in patients with cystic fibrosis. We look forward to working with the
FDA on introducing Bronchitol to the U.S. market as rapidly as possible."
Pharmaxis is currently conducting Phase III and II clinical trialsof Bronchitol
in cystic fibrosis patients at sites in Europe, Canada, Argentina and Australia.
<span class="FTHighlightFont">Cystic fibrosis affects approximately 75,000 people in the developed world,
including 33,000 US patients and 2,500 Australians -- a fifth of whom are
children under five years old. There have been no treatment advances in over a
decade, and no products are approved to improve lung hydration.</span ft>
Designation as a fast track product enables Pharmaxis to file the new drug
application on a rolling basis as data becomes available, allowing the FDA to
review the application in sections ahead of receiving the complete submission. A
complete submission is expected to be made in 2008.
Pharmaxis is developing Bronchitol as a treatment to improve mucusclearance in the lungs of patients
with cystic fibrosis, bronchiectasis and chronic obstructive pulmonary diseases.
Bronchitol is a patented, inhalable dry powder formulation of mannitol
administered by a hand-held, pocket sized device.
That last highlighted sentence?
Worldwide Biotech
January 1, 2007
US FAST-TRACKS PHARMAXIS CYSTIC FIBROSIS DRUG.
Pharmaceutical company Pharmaxis (NASDAQ<img src="i/expressions/face-icon-small-tongue.gif" border="0">XSL), Sidney, Australia,has announced
that the US Food and Drug Administration has designated Bronchitol as a
fast-track product for cystic fibrosis.
The FDA fast-tracks the New Drug Application (NDA) process if a therapy can
potentially address an unmet medical need for a life-threatening disease.
Designation as a fast-track product is designed to expedite regulatory review of
the Bronchitol NDA. The FDA and European Medicines Agency have both previously
granted Bronchitol orphan drug status for treating cystic fibrosis.
Pharmaxis chief executive officer Dr Alan Robertson said: "The FDAdecision is
encouraging news for thousands of cystic fibrosis patients. It recognises the
positive clinical data for Bronchitol in treating cystic fibrosis, which is a
lethal inherited condition.
"This designation will speed the process of bringing this potentially
life-saving drug to cystic fibrosis sufferers.
"Phase II studies show Bronchitol significantly improves lung function and
wellbeing in patients with cystic fibrosis. We look forward to working with the
FDA on introducing Bronchitol to the U.S. market as rapidly as possible."
Pharmaxis is currently conducting Phase III and II clinical trialsof Bronchitol
in cystic fibrosis patients at sites in Europe, Canada, Argentina and Australia.
<span class="FTHighlightFont">Cystic fibrosis affects approximately 75,000 people in the developed world,
including 33,000 US patients and 2,500 Australians -- a fifth of whom are
children under five years old. There have been no treatment advances in over a
decade, and no products are approved to improve lung hydration.</span ft>
Designation as a fast track product enables Pharmaxis to file the new drug
application on a rolling basis as data becomes available, allowing the FDA to
review the application in sections ahead of receiving the complete submission. A
complete submission is expected to be made in 2008.
Pharmaxis is developing Bronchitol as a treatment to improve mucusclearance in the lungs of patients
with cystic fibrosis, bronchiectasis and chronic obstructive pulmonary diseases.
Bronchitol is a patented, inhalable dry powder formulation of mannitol
administered by a hand-held, pocket sized device.
That last highlighted sentence?