Bayer Healthcare is stepping up with $155 million in cash and a big near-term milestone in exchange for the development and commercialization rights to an experimental anticoagulant from Isis Pharmaceuticals ($ISIS).
Isis announced this morning that it is getting $100 million upfront from Bayer for ISIS-FXI, an antisense Factor XI designed to prevent blood clots without significantly increasing the risk of bleeding. If Isis's development team can successfully steer through an ongoing Phase II study among patients with compromised kidney function, Bayer will hand over $55 million and take it into late-stage development. There's an undisclosed set of milestones and royalty stream to follow, provided it can reach the market.
Bayer already has a solid set of Phase II data to gauge the therapy's value. A year ago Isis reported that ISIS-FXI produced promising results in a Phase II study involving 300 patients undergoing knee replacement surgery. Investigators say patients taking the drug "experienced a seven-fold lower incidence of (venous thrombolic events) compared to patients treated with enoxaparin."
Bayer is planning to add ISIS-FXI to its pipeline as a follow-up to its anti-clotting drug Xarelto. The pharma company sees this program as a good follow-up for patients who are ineligible for Xarelto and its rivals now on the market.
Xarelto is one of the highest grossing anticoagulants to make its way onto the market in recent years, competing with Boehringer's Pradaxa and Pfizer/Bristol-Myers' Eliquis. Bayer estimates that the drug will peak with sales of close to $4 billion a year.
|Bayer's Joerg Moeller|
"This first-in-class FXI inhibitor perfectly complements our in-house thrombosis pipeline and is an innovative development candidate for a variety of anti-coagulation needs," said Dr. Joerg Moeller, who heads up global development at Bayer. "We believe the novel mechanism of Factor XI inhibition may offer an additional pathway for treating patients for whom there are currently no suitable therapeutic options available."
- here's the release