Bristol-Myers Squibb (BMS) will co-develop and co-commercialize Five Prime Therapeutics’ colony stimulating factor 1 receptor (CSF1R) antibody program—led by the Phase I cancer/immunology compound FPA008—in a deal that could generate up to $1.74 billion for Five Prime, the companies said today.
The new collaboration builds on an existing partnership focused on evaluating the safety, tolerability, and preliminary effectiveness of FPA008 with Opdivo in six tumor types. Five Prime will continue, to completion, the ongoing Phase Ia/Ib trial evaluating the combination in the six tumors, announced as part of the companies’ initial clinical collaboration in November 2014.
BMS will be responsible for global commercialization, while Five Prime retains rights to a U.S. co-promotion option, the companies said.
“This agreement, which builds upon our existing relationship with Five Prime in immuno-oncology, is another important example of our commitment to expanding our presence in this space and to researching novel combination regimens,” Francis Cuss, MB BChir, FRCP, evp and CSO of BMS, said in a statement.
Under the companies’ new license and collaboration agreement, BMS will oversee development and manufacturing of FPA008 for all indications—subject to an option by Five Prime to conduct, at its own expense, future studies including registrational studies to support approval of FPA008 in pigmented villonodular synovitis (PVNS) and FPA008 in combination with Five Prime’s internal pipeline assets in immuno-oncology.
BMS agreed to pay Five Prime $350 million upfront and up to $1.05 billion in payments tied to development and regulatory milestone per anti-CSF1R product for oncology indications—including combinations with Opdivo and any other agent.
In addition, BMS agreed to pay Five Prime up to $340 million in development and regulatory milestone payments per anti-CSF1R product for non-oncology indications, as well as double digit royalties. Those royalties will be increased in the U.S. should Five Prime exercise its co-promotion option, the companies said.
BMS will be responsible for development and manufacturing of FPA008 for all indications, subject to Five Prime’s option to conduct, at its own cost, certain future studies including registrational studies to support approval of FPA008 in PVNS and FPA008 in combination with Five Prime’s internal pipeline assets in immuno-oncology.
However, Five Prime will continue to conduct through to completion the current Phase Ia/Ib trial evaluating the combination of Opdivo and FPA008 in six tumor settings—non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer, and malignant glioma. The study was announced as part of the companies’ initial clinical collaboration in November 2014, and marked the expansion of a cancer-treatment alliance between the companies launched in March 2014.
BMS will be responsible for global commercialization, and Five Prime will retain rights to a U.S. co-promotion option.
“We believe this transformational collaboration with Bristol-Myers Squibb for our CSF1R antibody program represents the best of both worlds in terms of maximizing the potential of FPA008,” added Lewis T. “Rusty” Williams, M.D., Ph.D., Five Prime’s president and CEO.
“Bristol-Myers Squibb also has a rich pipeline of clinical candidates and approved products, a number of which may have therapeutic synergy when coupled with FPA008, given the potential of CSF1R inhibition to suppress the activity and survival of tumor associated macrophages,” Dr. Williams added.
The deal is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.