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Nektar Announces Inhaled Antibiotics Product to Prevent Pneumonia in Mechanically-Ventilated Patients

Posted on: Thursday, 29 September 2005, 15:00 CDT

Novel Preventative Solution Designed to Lower the Morbidity and Mortality of Ventilated Patients in a Critical Care Setting and Reduce Hospital Costs

Nektar Therapeutics (Nasdaq:NKTR) today announced the company is developing Inhaled ICU antibiotics for the prevention of ventilator-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 novel drug-device system uses a nebulizer and Nektar proprietary adapter technology, along with a unique formulation of liquid antibiotics, to target the lungs directly with preventative doses of medicine in a ventilated patient. The product is designed to work with a full range of ventilator types and settings making it easy-to-use for hospital practitioners.

"Nektar's Inhaled ICU antibiotics represents a potential advance in critical care medicine by preventing costly and fatal pneumonia for the 450,000 patients in the US that are at highest risk for this disease," said Dr. Andy Clark, Nektar Senior Fellow and Chief Technical Officer. "By using our pulmonary delivery expertise, we have designed a product to target the site of bacterial infection reproducibly and safely to enable prevention. Nektar has the opportunity to develop the first therapy to prevent VAP."

A proof-of-principle study sponsored by Nektar demonstrated that aerosolized antibiotics reduces the persistence of VAP after its onset by approximately half as compared to placebo.(1) Nektar expects to initiate a Phase II dose confirmation study in mid-2006.

"VAP is a serious life-threatening disease and there is no adequate preventative treatment today that inhibits its onset," said Dr. Michael Matthay, Professor of Medicine and Anesthesia at University of California, San Francisco. "Current IV therapy treatments for VAP can cause side effects and can contribute to an extended hospital stay and more time in the ICU. This is clearly an unmet medical need and I am very encouraged by Nektar's focus on prevention."

Nektar Inhaled ICU Antibiotics

Nektar Inhaled ICU antibiotics features a Nektar proprietary circuit adapter used with a nebulizer that connects to a ventilator setting. The adapter increases efficiency and reduces delivery time within a ventilator setting. In addition, the product has a specialized formulation of two liquid antibiotics, Gentamicin and Vancomycin, with easy-to use unit dosing for each. Gentamicin is a well-established bactericidal antibiotic that at high doses is effective at targeting gram negative bacteria that is the cause of VAP. Vancomycin is a potent bactericidal gram positive agent commonly used in severe infections, including Methacillin-resistant staphylococcal infections. The system can be used with a full range of ventilator settings and can be easily administered by hospital practitioners in an intensive care unit.

About Ventilator-Associated Pneumonia

Studies show that VAP can result in extended hospital stays and higher hospital costs. A study published in Chest by Rello et al. in December 2002 reported that for ventilated patients, a secondary diagnosis of pneumonia contributed to 9 more days on a ventilator and up to 12 added days of hospital care, costing up to $40,000 more per patient.(2) VAP also has a 20-30% higher risk of death compared to other underlying diseases in mechanically-ventilated patients.(3) VAP is one of the most common secondary diagnoses in ventilated patients within a critical care setting, affecting up to 28% of patients on mechanical ventilators.(3) The most common VAP-causing bacteria are Pseudomonas aeruginosa and Staphylococcus aureus.(3) Approximately 800,000 patients in the U.S. are mechanically ventilated each year and up to 450,000 are at high risk of developing VAP each year.(4)

The announcement was made at Nektar Investor Day 2005 in New York City on September 29, 2005, where the company outlined its proprietary programs and its strategy to reach profitability and achieve sustained revenue growth. In a separate press release, Nektar also announced its inhaled amphotericin B product to prevent fatal lung infections in immunocompromised patients.

About Nektar

Nektar Therapeutics 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 business strategy, product and technology development plans and funding, collaborative arrangements, clinical trials, and other future events and operations. These forward-looking statements involve uncertainties and other risks that 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 June 30, 2005. Actual results could differ materially from these forward-looking statements.

(1.) Institutional Review Board-approved study at the State University 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 of ventilator-associated pneumonia in a large US database. Chest. 2002;122(6):2115-2121.

(3.) Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002; 16(7):867-903.

(4.) Healthcare Cost and Utilization Project (HCUP), United States Department of Health and Human Services, 2003; 200 physician interviews in a studies sponsored by Nektar, 2003-2005.

Source: Business Wire

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