Cytokinetics Incorporated, a biopharmaceutical company, and Amgen announced a strategic collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure.
In addition, Amgen obtained an option to participate in future development and commercialization of Cytokinetics' lead drug candidate arising from this programme, CK-1827452, which recently completed two phase 1 clinical trials. The collaboration is worldwide, excluding Japan.
Under the terms of the agreement, Cytokinetics receives a non-refundable up-front license and technology access fee of $42 million. In addition, Amgen has purchased 3,484,806 shares of Cytokinetics common stock at $9.47 per share and an aggregate purchase price of approximately $33 million.
Joint research activities will focus on identifying and characterizing activators of cardiac myosin as back-up and follow-on potential drug candidates to CK-1827452. During the initial two year research term, in addition to performing research at its own expense under the collaboration, Cytokinetics will continue to conduct all development activities at its own expense for CK-1827452 subject to Amgen's option and according to an agreed development plan. Amgen's option is exercisable upon the satisfaction of certain conditions including CK-1827452 being developed to meet pre-defined criteria in phase 2a clinical trials. To exercise its option, Amgen would pay a non-refundable exercise fee of $50 million and thereafter will be responsible for development and commercialization of CK-1827452 and related compounds, at its expense, subject to development and commercial participation rights of Cytokinetics.
In addition, Cytokinetics may be eligible to receive pre-commercialization and commercialization milestone payments of up to $600 million on CK-1827452 and other products arising from the research as well as royalties that escalate based on increasing levels of annual net sales of products commercialized under the collaboration. Cytokinetics also has the opportunity to earn increased royalties by participating in Phase 3 development costs. In that case, Cytokinetics could co-promote products in North America and would be expected to play a significant role in the agreed commercial activities in institutional care settings, at Amgen's expense. If Amgen elects not to exercise its option on CK-1827452, Cytokinetics may then proceed to independently develop CK-1827452 and the research collaboration would terminate.
"We are pleased to be working with Amgen toward the further advancement of our research in cardiac contractility and the potential advancement of CK-1827452 through proof-of-concept stage testing in clinical trials," stated Cytokinetics chief executive officer James Sabry. "Amgen's leadership in innovation and novel biopharmaceutical mechanisms is well known. The creative structure of this alliance reinforces the enthusiasm we both share for this area and our respective interests to together build on this attractive opportunity in the treatment of heart failure."
Amgen executive vice president for Research and Development, Roger M. Perlmutter, M.D., Ph.D., said, "At Amgen, we are committed to addressing mankind's most grievous illnesses, including heart failure, by harnessing the world's most innovative science. Hence we are delighted to have the opportunity to join forces with Cytokinetics. Using their advanced understanding of cardiac contractility, we hope to develop therapies that will improve the lives of heart failure patients around the world."
Upon announcing the collaboration, Amgen reiterated guidance of adjusted earnings per share of $3.85 - $3.95 for 2006.