Nektar Therapeutics has entered into an agreement with Daiichi Sankyo Europe for Nektar’s investigational drug therapy, Onezald (etirinotecan pegol), which has completed a Phase III clinical trial in patients with advanced breast cancer. The agreement grants Daiichi Sankyo Europe exclusive rights to market Onezald in Europe (EEA), Switzerland and Turkey. Nektar Therapeutics will retain rights to Onezald in the United States and the rest of the world.

Under the agreement, Nektar Therapeutics is entitled to an upfront payment of $20 million as well as an additional $60 million in milestone payments, based upon the achievement of European regulatory milestones and European sales of Onezald. Nektar is also entitled to significant double-digit royalties on net sales in Europe.

Nektar plans to submit a marketing authorization application (MAA) filing in June 2016 seeking conditional approval from the European Medicines Agency (EMA) for the use of Onezald in the treatment of patients with advanced breast cancer and brain metastases. On May 26, 2016, the Committee for Medicinal Products for Human Use (CHMP) granted an accelerated assessment procedure for the planned Onezald filing, which provides for an accelerated MAA review timeline.

Nektar will be responsible for sponsoring and funding the confirmatory trial which will support the MAA filing for Onezald in Europe. The data from the confirmatory trial can be used by Nektar for a potential U.S. new drug application filing.

Source: Nektar Therapeutics