Bayer HealthCare, Nektar Therapeutics To Fight Gram-Negative Pneumonias

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Gram-Negative Pneumonias

Bayer HealthCare and Nektar Therapeutics have agreed to develop and commercialize NKTR-061 (inhaled amikacin) to fight gram-negative pneumonias.

This potentially innovative therapy would utilize Nektar's proprietary pulmonary technology to deliver a specially-formulated amikacin, an aminoglycoside antibiotic, for inhalation deep into the lung. NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality.

"This new development agreement reinforces our commitment to fight infectious and respiratory diseases and is a natural fit with Bayer HealthCare's strategy of developing and marketing specialty pharmaceutical products," said Dr. Ulrich Kostlin, Member of the Executive Committee of Bayer HealthCare. There is a large, unmet medical need for a new approach to fight Gram-negative pneumonias, particularly in ventilated patients infected with difficult to treat, resistant organisms. Nektar's pulmonary drug delivery technology offers a very promising approach to address this unmet medical need.

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As part of this agreement, Nektar will receive milestone payments of up to $175 million associated with the successful development and commercialization of NKTR-061. This includes an upfront payment of $50 million. Subsequent to the successful clinical and regulatory development of the product, Bayer HealthCare and Nektar have agreed to a co-promotion of the product in the United States and to share profits. For sales outside the United States, Nektar will receive tiered performance royalties up to a maximum of 30%.

Under the terms of the agreement, Bayer HealthCare is responsible for the global clinical development, regulatory strategy, manufacturing and marketing of the product, with Nektar participating in all aspects of decision-making and governance.

"We're very pleased to be collaborating with Bayer HealthCare, a world leader in anti-infective therapies," said Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics. "Utilizing Nektar's proprietary pulmonary technology to address life-threatening infections, Bayer HealthCare and Nektar are building on the important work we're doing in the area of pulmonary therapeutics."

Currently, NKTR-061 is being studied in Phase 2 trials for the adjunctive therapy of ventilated patients with hospital-acquired, Gram-negative pneumonias. These pneumonias are a serious problem afflicting patients even in the world's most advanced clinical settings and are responsible for a significant number of deaths. Increasingly, multi-drug resistant, Gram-negative bacteria have magnified the problem of hospital-acquired infection. Gram-negative pneumonias are commonly seen in patients receiving immunosuppressive therapy, the elderly, and patients undergoing major surgical procedures, aspiration, long hospital stays and prolonged mechanical ventilation. Current treatment involves the administration of systemic antibiotics, which produces significant toxicities and results in marginal benefit to the patient. Some 20-50 percent of patients intubated and on ventilators who acquire Gram-negative pneumonia will die. NKTR-061 (inhaled amikacin), if approved, would be administered while the patient is on the ventilator and also would allow for ongoing dosing (transition therapy) after the patient no longer requires ventilatory support.

This collaboration is Bayer HealthCare's second with Nektar. In 2005, Bayer and Nektar agreed to collaborate on the joint development of inhaled ciprofloxacin as a potential dry powder therapy for treating pseudomonal infections in patients suffering from cystic fibrosis.

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