FDA Confers Fast Track Status On Nektar's Anti-fungal Inhaler

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FDA Confers Fast Track Status On Nektar's Anti-fungal Inhaler To

Prevent Fatal Infections - Update

Monday, May 22, 2006; Posted: 10:42 AM

http://www.tradingmarkets.com/tm.site/news/BREAKING%20NEWS/261199/

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(RTTNews) - Monday, Nektar Therapeutics (NKTR | charts | news |

PowerRating) said the FDA conferred Fast Track status on its inhaled

medication for preventing pulmonary fungal infections in patients

receiving organ or stem cell transplants, or undergoing Chemotherapy

or radiation treatment for blood Cancer.

A Fast Track designation allows the FDA to accelerate the review of

new drugs intended for serious or life-threatening conditions, with

the potential to address unmet medical needs.

Nektar's drug - Amphotericin B Inhalation Powder or ABIP is being

evaluated in a multidose initial stage study, as a therapy for

preventing pulmonary aspergillosis in high-risk immunosuppressed

patients - who receive organ or stem cell transplants, or

chemotherapy or radiation therapy for Blood cancers.

Immunosuppressed patients are susceptible to fungal infections -

like aspergillosis, which start in the lungs and spread throughout

the body, with a mortality rate of over 50% and as high as 100% in

some cases.

The worldwide market for Aspergillosis therapeutics is estimated to

be about $500 million.

In February 2006, Nektar said that ABIP received U.S. orphan drug

designation from the FDA for the same indication. The Orphan Drug

status provides a seven year marketing exclusivity to the drug,

subject to approval.

NKTR is currently trading at $19.58, down 12 cents.