29.09.2005 17:32:00
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Nektar Announces Inhaled Antibiotics Product to Prevent Pneumonia in Mechanically-Ventilated Patients
Nektar Therapeutics (Nasdaq:NKTR) today announced the company isdeveloping Inhaled ICU antibiotics for the prevention ofventilator-associated pneumonia (VAP) in the intensive care unit(ICU). VAP is a form of hospital-acquired, or nosocomial pneumonia,occurring in patients on mechanical ventilators. Nektar's noveldrug-device system uses a nebulizer and Nektar proprietary adaptertechnology, along with a unique formulation of liquid antibiotics, totarget the lungs directly with preventative doses of medicine in aventilated patient. The product is designed to work with a full rangeof ventilator types and settings making it easy-to-use for hospitalpractitioners.
"Nektar's Inhaled ICU antibiotics represents a potential advancein critical care medicine by preventing costly and fatal pneumonia forthe 450,000 patients in the US that are at highest risk for thisdisease," said Dr. Andy Clark, Nektar Senior Fellow and ChiefTechnical Officer. "By using our pulmonary delivery expertise, we havedesigned a product to target the site of bacterial infectionreproducibly and safely to enable prevention. Nektar has theopportunity to develop the first therapy to prevent VAP."
A proof-of-principle study sponsored by Nektar demonstrated thataerosolized antibiotics reduces the persistence of VAP after its onsetby approximately half as compared to placebo.(1) Nektar expects toinitiate a Phase II dose confirmation study in mid-2006.
"VAP is a serious life-threatening disease and there is noadequate preventative treatment today that inhibits its onset," saidDr. Michael Matthay, Professor of Medicine and Anesthesia atUniversity of California, San Francisco. "Current IV therapytreatments for VAP can cause side effects and can contribute to anextended hospital stay and more time in the ICU. This is clearly anunmet medical need and I am very encouraged by Nektar's focus onprevention."
Nektar Inhaled ICU Antibiotics
Nektar Inhaled ICU antibiotics features a Nektar proprietarycircuit adapter used with a nebulizer that connects to a ventilatorsetting. The adapter increases efficiency and reduces delivery timewithin a ventilator setting. In addition, the product has aspecialized formulation of two liquid antibiotics, Gentamicin andVancomycin, with easy-to use unit dosing for each. Gentamicin is awell-established bactericidal antibiotic that at high doses iseffective at targeting gram negative bacteria that is the cause ofVAP. Vancomycin is a potent bactericidal gram positive agent commonlyused in severe infections, including Methacillin-resistantstaphylococcal infections. The system can be used with a full range ofventilator settings and can be easily administered by hospitalpractitioners in an intensive care unit.
About Ventilator-Associated Pneumonia
Studies show that VAP can result in extended hospital stays andhigher hospital costs. A study published in Chest by Rello et al. inDecember 2002 reported that for ventilated patients, a secondarydiagnosis of pneumonia contributed to 9 more days on a ventilator andup to 12 added days of hospital care, costing up to $40,000 more perpatient.(2) VAP also has a 20-30% higher risk of death compared toother underlying diseases in mechanically-ventilated patients.(3) VAPis one of the most common secondary diagnoses in ventilated patientswithin a critical care setting, affecting up to 28% of patients onmechanical ventilators.(3) The most common VAP-causing bacteria arePseudomonas aeruginosa and Staphylococcus aureus.(3) Approximately800,000 patients in the U.S. are mechanically ventilated each year andup to 450,000 are at high risk of developing VAP each year.(4)
The announcement was made at Nektar Investor Day 2005 in New YorkCity on September 29, 2005, where the company outlined its proprietaryprograms and its strategy to reach profitability and achieve sustainedrevenue growth. In a separate press release, Nektar also announced itsinhaled amphotericin B product to prevent fatal lung infections inimmunocompromised patients.
About Nektar
Nektar Therapeutics enables high-value, differentiatedtherapeutics with its industry-leading drug delivery technologies,expertise and manufacturing capabilities. The world's topbiotechnology and pharmaceutical companies are developing new andbetter therapeutics using Nektar's advanced technologies and know-how.Nektar also develops its own products by applying its drug deliverytechnologies and its expertise to existing medicines to enhanceperformance, such as improving efficacy, safety and compliance.
This release contains forward-looking statements that reflectmanagement's current views as to Nektar's business strategy, productand technology development plans and funding, collaborativearrangements, clinical trials, and other future events and operations.These forward-looking statements involve uncertainties and other risksthat are detailed in Nektar's reports and other filings with the SEC,including its Annual Report on Form 10-K, as amended, for the yearended December 2004 and its Quarterly Report on 10-Q for the quarterended June 30, 2005. Actual results could differ materially from theseforward-looking statements.
(1.) Institutional Review Board-approved study at the StateUniversity of New York, Stony Brook; Smaldone, G, Palmer, L., 2003,study sponsored by Nektar.
(2.) Rello J. Ollendorf DA, Oster G. Vera-Llonch V, Bellm L,Redman R, Kollef MH.:Epidemiology and outcomes ofventilator-associated pneumonia in a large US database. Chest.2002;122(6):2115-2121.
(3.) Chastre J, Fagon JY. Ventilator-associated pneumonia. Am JRespir Crit Care Med. 2002; 16(7):867-903.
(4.) Healthcare Cost and Utilization Project (HCUP), United StatesDepartment of Health and Human Services, 2003; 200 physicianinterviews in a studies sponsored by Nektar, 2003-2005.
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