Amgen Inc. announced a new cancer research collaboration on Monday, even as another pharma giant moved toward production of a drug that would compete against the company’s white blood cell treatment Neupogen.
The Thousand Oaks company has formed a strategic collaboration and license agreement with Kite Pharma in Santa Monica to develop a new immunotherapy drug. Kite will be responsible for preclinical research and cell manufacturing up to the point of filing an investigational new drug application with the Food and Drug Administration. After that, each company will pay for clinical research and commercialization of their respective drugs based on Kite’s technology.
Kite will receive an upfront payment of $60 million from Amgen, as well as funding for R&D costs. And it could receive up to $525 million in milestone payments if Amgen’s drug moves toward regulatory approval and commercialization. In addition, Kite could receive royalty payments from sales. Likewise, Amgen could receive up to $525 million in addition to sales royalties if Kite’s drug reaches the market.
Meanwhile, the FDA staff has recommended approval for a drug from Novartis AG that would compete directly with Neupogen, one of Amgen’s biggest cash cows.
Neupogen accounted for about $1.2 billion in revenue for Amgen in 2014. The drug stimulates production of white blood cells in bone marrow and is given to patients undergoing radiation or chemotherapy, which depletes white cell counts.
The Novartis drug, called Zarzio, is the first biosimilar drug to receive staff approval. Biosimilars are medicines that copy proprietary biotech drugs when patent protection expires. Because small differences in environment or manufacturing processes may alter the final product, the drugs are called similar – but not identical – to the original drug.
In documents released Monday, the FDA staff found “no clinically meaningful differences” between Neupogen and copycat Zarzio. An FDA panel of experts will vote to approve or reject the staff recommendation on Wednesday.
Amgen shares closed down $1.90, or more than 1 percent, to $157.99 on the Nasdaq.