Bayer, Nektar Collaborate on Inhaled Antibiotic

Bayer HealthCare and Nektar Therapeutics have agreed to develop and commercialize NKTR-061 (inhaled amikacin). NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality. Nektar’s proprietary pulmonary technology would be employed to deliver a specially-formulated amikacin, an aminoglycoside antibiotic, for inhalation deep into the lung.

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. Folowing successful clinical and regulatory development of the product, the companies have agreed to co-promote the product in the U.S. and to share profits. For ex-U.S. sales, Nektar will receive tiered performance royalties up to a maximum of 30%.

Under the terms of the agreement, Bayer 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.


“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, a member of the Bayer’s executive committee.

Currently, NKTR-061 is being studied in Phase II 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. 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 is the second collaboration between Bayer and Nektar. In 2005, they 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.