Bayer HealthCare and Nektar Therapeutics to develop innovative pneumonia therapy

Bayer HealthCare has entered into a co-operation with Nektar Therapeutics to develop and market an innovative therapy to fight Gram-negative pneumonias.

This new treatment method will utilise Nektar's proprietary pulmonary technology to deliver a specially formulated amikacin (NKTR-061), an aminoglycoside antibiotic, for inhalation deep into the lung. Amikacin for inhalation is undergoing Phase II clinical trials as a new approach for an unmet medical need to fight acute Gram-negative pneumonias that often lead to significant morbidity and mortality in ventilated patients.

As part of this agreement, Nektar will receive milestone payments of up to US$175m associated with the successful development and commercialisation of NKTR-061. This includes an upfront payment of $50m.

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 US and to share profits. For sales outside the US, 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.

"This development agreement is a natural fit with Bayer HealthCare's strategy of developing and marketing speciality pharmaceutical products," said Dr Ulrich Koestlin, board member of Bayer Schering Pharma, responsible for the business unit primary care.

Bayer HealthCare and Nektar started to co-operate in 2005 with the joint development of inhaled ciprofloxacin as a potential dry powder therapy for treating pseudomonal infections in patients suffering from cystic fibrosis. This development project received orphan drug status for the approval by the EMEA in July 2007.