First Amphotericin B Inhalation Powder to Prevent Pulmonary Fungal Infections

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Nektar Announces That U.S. FDA Has Granted Orphan Drug Designation

to the First Amphotericin B Inhalation Powder to Prevent Pulmonary

Fungal Infections in Immunosuppressed Patients

2/14/2006 8:30:00 AM EST

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Nektar Therapeutics (Nasdaq:NKTR) announced today the U.S. Food and

Drug Administration (FDA) has granted orphan drug designation to the

first amphotericin B inhalation powder for prevention of pulmonary

fungal infections in patients at risk for aspergillosis due to

immunosuppressive therapy. Using a small proprietary pocket size

inhaler, the company has conducted two Phase I trials and has long-

term toxicity studies underway to support the planned pivotal trials

early next year.

Immunosuppressed patients -- i.e., those receiving organ or stem

cell transplants, or chemotherapy or radiation therapy for

hematologic malignancies -- commonly develop fungal infections in

their lungs which spread throughout the body (aspergillosis).

Inhaling amphotericin B inhalation powder into the lungs prior to

developing an aspergillosis infection may potentially reduce the

incidence of these infections as well as the subsequent high

morbidity and mortality and significant treatment costs associated

with them. Nektar developed the amphotericin B inhalation powder to

target the lungs directly with this potent, broad spectrum,

fungicidal " gold-standard " antifungal drug, while potentially

eliminating systemic toxicities associated with current formulations

of amphotericin B which must be delivered intravenously.

Orphan products are developed to treat diseases or conditions that

affect fewer than 200,000 people in the U.S. The Orphan Drug Act

provides a seven-year period of exclusive marketing to the first

sponsor who obtains marketing approval for a designated orphan drug.

" Given the high incidence of invasive aspergillosis in

immunocompromised patients, and high mortality rates despite

available therapies, this potential new therapy could represent a

significant breakthrough in antifungal medicine, " said Kieren Marr,

M.D., Assistant Professor Medicine, Allergy and Infectious Diseases,

Fred Hutchinson Cancer Research Center, Seattle, Washington.

" In the U.S., more than 75,000 immunocompromised patients annually

are at risk of developing often fatal and costly fungal infections

in the lungs. There are no approved pharmaceutical therapies to

prevent fungal infections like aspergillosis, caused when

Aspergillus, a widely prevalent genus of molds, infects the lungs

and invades the body, causing systemic infections that are very

difficult to cure and are associated with an extremely high

mortality rate, " said Dr. ston, Nektar Senior Vice

President, Research and Development.

" Fungal spores are routinely inhaled. An immunosuppressed patient is

susceptible to fungal infections, like aspergillosis, normally not

seen in those with healthy immune systems. Nektar's approach

delivers amphotericin B directly to the potentially vulnerable organ

through inhalation in the same manner that the fungal spores are

inhaled, and could represent a breakthrough in prevention of these

infections with such high mortality rates, " said ston.

The FDA granted orphan drug designation to Nektar's amphotericin B

inhalation powder upon review of the application which included pre-

clinical data presented at the 45th Annual Interscience Conference

on Antimicrobial Agents and Chemotherapy (ICAAC) in December 2005.

These data indicated that the inhaleable amphotericin B provided a

statistically significant improvement in survival of

immunosuppressed rabbits challenged with a pulmonary dose of

Aspergillus fumigatus spores. In separate toxicology studies, there

was little or no pulmonary toxicity when animals were administered

ten times or more than the expected amphotericin B powder dose for

humans. Further, data indicated that there was no systemic toxicity

and low amounts of the drug in the bloodstream -- less than the

concentration generally regarded as toxic in blood in humans -- even

when delivered at doses more than ten times the level expected for

humans.

Data from the two clinical studies completed to date reinforce the

pre-clinical results. Nektar scientists will present data from the

first of these clinical studies at upcoming conferences, including:

2nd Advances Against Aspergillosis, Athens, Greece, February 22-25,

2006; and Focus on Fungal Infections 16, Las Vegas, Nevada, March 8-

10, 2006. Pivotal trials are on target to begin in early 2007.

Nektar Amphotericin B Inhalation Powder

Amphotericin B is a potent, broad spectrum, fungicidal drug which

has been used intravenously for decades for treatment and remains

the " gold-standard " therapy for fighting fungal infections, limited

only by its systemic toxicities. The Nektar amphotericin B

inhalation powder product enables the inhalation of a therapeutic

concentration of amphotericin B directly to the lungs, at levels

similar to or greater than the lung concentrations achieved by

intravenous dosing of amphotericin B or lipid-associated

amphotericin B products. By delivering amphotericin B directly to

the site of potential infection, Nektar's inhaleable amphotericin B

will potentially eliminate life-threatening pulmonary fungal

infections, while minimizing common dose-limiting toxicities

associated with intravenous amphotericin B therapy. Nektar's unique

delivery mode has been designed to encourage long-term compliance

and may have significant cost benefits for this high-risk patient

population.

About Nektar

Nektar Therapeutics develops and enables high-value, differentiated

therapeutics with its industry-leading drug delivery technologies,

expertise and manufacturing capabilities. The world's top

biotechnology and pharmaceutical companies are developing new and

better therapeutics using Nektar's advanced technologies and know-

how. Nektar also develops its own products by applying its drug

delivery technologies and its expertise to existing medicines to

enhance performance, such as improving efficacy, safety and

compliance.

This release contains forward-looking statements that reflect

management's current views as to Nektar's clinical plans and

expectations for a product under development, the potential for new

product efficacy, safety, compliance, and economic benefits for

patients and the value and benefits of Nektar technologies. These

forward-looking statements involve substantial risks and

uncertainties including without limitation the uncertainty and

expense of the clinical trial and regulatory process for new

products and the commercial feasibility of early stage development

products. A further description of other important risks and

uncertainties related to these forward-looking statements are

detailed in Nektar's reports and other filings with the SEC,

including its Annual Report on Form 10-K, as amended, for the year

ended December 2004 and its Quarterly Report on 10-Q for the quarter

ended September 30, 2005. Actual results could differ materially

from these forward-looking statements.

CONTACT:

Nektar Therapeutics Joyce Strand, 650-631-3138 Ruddock, 650-

631-4954