Amgen and Cytokinetics said today they will expand a seven-year-old collaboration by extending to Japan their license agreement for omecamtiv mecarbil, a heart failure treatment now in clinical trials, and related compounds, in a deal that could net Cytokinetics up to $75 million-plus.
Amgen has a license to develop the Cytokinetics-discovered omecamtiv mecarbil, a small molecule, direct activator of cardiac myosin under evaluation in both intravenous and oral formulations. Under their amended collaboration agreement, Cytokinetics plans to conduct a Phase I pharmacokinetic study, costs of which will be reimbursed by Amgen. The Phase I study is intended to support inclusion of Japanese patients in a potential Phase III clinical development program for omecamtiv mecarbil.
In return for the expansion, Amgen will pay Cytokinetics $25 million up-front cash—a nonrefundable $15 million license fee and $10 million toward the purchase of Cytokinetics’ common stock—plus up to $50 million in payments tied to undisclosed precommercialization milestones for omecamtiv mecarbil in Japan, as well as royalties on sales of the drug candidate in Japan.
Amgen agreed to buy Cytokinetics stock at a price per share equal to the 10-day trailing average of the closing price of Cytokinetics’ stock on the last trading day prior to execution of the stock purchase agreement.
“Our decision to amend the agreement at this time is based on our confidence in the progress of our collaborative development program for omecamtiv mecarbil and on Amgen’s recent commitment to expand its business activities in Japan,” Robert I. Blum, Cytokinetics’ president and CEO, said in a statement.
Amgen agreed to shell out up to $675 million-plus for its original heart failure collaboration with Cytokinetics covering the rest of the world—a $42 million up-front “license and technology access fee,” $33 million toward purchase of Cytokinetics shares, and up to $600 million in payments tied to precommercialization and commercialization milestones.
The original deal also gave Amgen an option to continue the collaboration by paying Cytokinetics an additional, nonrefundable $50 million—an option Amgen exercised in 2009, in return for assuming responsibility for development and commercialization of omecamtiv mecarbil (then named CK-1827452) and related compounds, at its expense.
Amgen’s expansion of its collaboration with Cytokinetics to Japan is the fourth initiative announced this year, and the third in five weeks, by the biotech giant toward shoring up its presence in Japan and the rest of Asia. Most recently on May 29, Amgen said it will co-develop and co-commercialize five of its pipeline medicines—three of them now in Phase III development—with Astellas Pharma in Japan, in the first project of a strategic alliance designed to address unmet medical needs of Japanese patients.