Nektar Therapeutics NKTR announced that it has signed an agreement to grant Daiichi Sankyo Europe the exclusive rights to market Onzeald (etirinotecan pegol) in Europe (EEA), Switzerland and Turkey.
Onzeald, formerly NKTR-102, is being developed for the treatment of patients with advanced breast cancer who have a history of brain metastases. The company has completed a phase III study – BEACON – in women with locally recurrent or metastatic breast cancer, who were previously treated with anthracycline, taxane and Xeloda (capecitabine) therapies.
As per the terms of the agreement, Nektar will receive an upfront payment of $20 million from Daiichi Sankyo. In addition, the company is entitled to receive additional milestone payments worth $60 million, based upon the achievement of European regulatory milestones and sales of Onzeald in Europe. It will also earn double-digit royalties on net sales in Europe. Nektar retains rights to market Onzeald in the U.S. and the rest of the world.
The company intends to submit a Marketing Authorisation Application (MAA) in the EU this month for a conditional approval of Onzeald for the treatment of patients with advanced breast cancer and brain metastases. We note that last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment procedure for the planned regulatory filing.
In order to support an MAA filling, Nektar will conduct a confirmatory study on Onzeald. The randomized phase III study will evaluate Onzeald, in comparison with a single-agent chemotherapy of physician's choice (TPC), in patients (n~350) with advanced breast cancer and brain metastases. The primary endpoint of the study is the overall survival. Data from the study will also be used for filing for a New Drug Application (NDA) for Onzeald in the U.S.
It has been found that approximately 10–30% of patients with advanced breast cancer are diagnosed with brain metastases.
Nektar currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company BMY, ANI Pharmaceuticals, Inc. ANIP and Pfizer Inc. PFE, each sporting a Zacks Rank #1 (Strong Buy).
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