The California-based Nektar Therapeutics and Chiron, a Novartis company are collaborating for a next-generation, dry powder tobramycin to treat lung infections in Cystic Fibrosis patients. The product, which is called Tobramycin Inhalation Powder (TIP), is currently in phase III trials, Dr Sarma P Duddu, managing director, Nektar Therapeutics (India) told Pharmabiz.
Chiron introduced TOBI in 1998 as the first inhaled antibiotic given by nebulizer to Cystic Fibrosis patients. Nektar's dry powder formulation represents a next generation therapy that allows patients to receive higher doses for improved efficacy without the lengthy administration time of TOBI.
Nektar is collaborating with Bayer HealthCare AG to develop an inhaled, dry powder formulation of ciprofloxacin to treat Cystic Fibrosis and other chronic lung infections, he informed.
The company is also evaluating an inhaled antifungal product to prevent pulmonary aspergillosis in immuno-suppressed patients. ABIP (amphotericin B inhalation powder) is designed to target the site of infection directly with a novel formulation of amphotericin B, a broad spectrum, "gold-standard" antifungal drug.
This year, Nektar's Amphotericin B Inhalation Powder (ABIP) product has been granted orphan medicinal product designation by the US FDA and European Commission for the prevention of pulmonary fungal infections in patients deemed at risk. ABIP recently completed a multi-dose, dose escalation clinical study in preparation for pivotal trials to begin in 2007.
Pulmonary delivery directly at the site of infection could potentially eliminate systemic, dose-limiting toxicities found with current formulations of amphotericin B that are delivered intravenously. Aspergillosis has a high mortality rate of over 50 per cent, and in some immuno-suppressed patient groups the mortality rate may be as high as 100 per cent, he pointed.
Nektar is a biopharmaceutical company that develops and enables differentiated therapeutics with its drug delivery technologies, expertise and manufacturing capabilities. The company's technology and know-how have enabled nine approved products for partners, which include the world's leading pharmaceutical and biotechnology companies.
Nektar also develops its own products by applying its drug delivery technologies and expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.