Amgen Exercises Option for Exclusive License to Cytokinetics’ Cardiac Contractility Program That Includes CK-1827452
Cytokinetics Receives Exercise Fee of
Cytokinetics to Host a Conference Call
Under the terms of the companies’ 2006 collaboration and option agreement, Amgen has agreed to pay Cytokinetics a non-refundable exercise fee of
“After reviewing the data from the CK-1827452 clinical trials, we are excited about the opportunity to advance this molecule,” said Amgen Executive Vice President for Research and Development,
“Recently completed clinical trials of CK-1827452 suggest that this drug candidate may represent a major step forward in the treatment of heart failure,” stated Cytokinetics’ President and Chief Executive Officer,
Conference Call / Webcast
Cytokinetics will host a conference call on
Background on the Collaboration
Development Status of CK-1827452
CK-1827452, a novel cardiac myosin activator, has been the subject of a clinical trials program comprised of multiple Phase 1 and Phase 2a trials. This program was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetic profile of both intravenous and oral formulations of CK-1827452 for the potential treatment of heart failure across the continuum of care, in both hospital and outpatient settings. Two Phase 2a clinical trials of CK-1827452 from this program have been completed, and two Phase 2a clinical trials of CK-1827452 are ongoing.
The first Phase 2a clinical trial evaluated CK-1827452 in patients with stable heart failure. Data from that trial were recently presented at the American College of Cardiology Meeting in
In addition, Cytokinetics has conducted five Phase 1 clinical trials of CK-1827452 in healthy subjects: a first-time-in-humans study evaluating an intravenous formulation, an oral bioavailability study evaluating both intravenous and oral formulations, and three studies of oral formulations: a drug-drug interaction study, a dose proportionality study and a study evaluating modified-release formulations. Data from each of these trials have been reported previously.
Background on Cardiac Myosin Activators and Cardiac Contractility
Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac contractility is driven by the cardiac sarcomere, a highly ordered cytoskeletal structure composed of cardiac myosin, actin and a set of regulatory proteins, and is the fundamental unit of muscle contraction in the heart. The sarcomere represents one of the most thoroughly characterized protein machines in human biology. Current inotropic agents, such as beta-adrenergic receptor agonists or inhibitors of phosphodiesterase activity, increase cardiac cell contractility by increasing the concentration of intracellular calcium, which further activates the cardiac sarcomere. This effect on calcium levels, however, also has been linked to potentially life-threatening side effects. The inotropic mechanism of current drugs also increases the velocity of cardiac contraction and shortens systolic ejection time. In contrast, cardiac myosin activators have been shown to work in the absence of changes in intracellular calcium by a novel mechanism that directly stimulates the activity of the cardiac myosin motor protein. Cardiac myosin activators accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. This inotropic mechanism results not in an increase in the velocity of cardiac contraction, but instead, in a lengthening of the systolic ejection time, which results in increased cardiac contractility and cardiac function in a potentially more oxygen-efficient manner.
Background on Heart Failure Market
Heart failure is a widespread and debilitating syndrome affecting millions of people in
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Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. The company’s drug candidates and potential drug candidates have arisen from research activities that are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Cytokinetics’ focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drug candidates directed at treatments for cardiovascular disease, cancer and other diseases. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
Forward-Looking Statements: Amgen
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Forward-Looking Statements: Cytokinetics
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act’s safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ collaboration with Amgen, including potential milestone payments and other payments and funding and the expected roles of Cytokinetics and Amgen under the collaboration and in developing or commercializing drug candidates or drugs subject to the collaboration; statements relating to the clinical development of CK-1827452, including the initiation, design, enrollment, conduct and results of clinical trials and the significance of such results, and planned presentations relating to clinical trial results; the size and growth of expected markets for heart failure therapeutics, including CK-1827452; and the properties and potential benefits of CK-1827452 and Cytokinetics’ other drug candidates and potential drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or production of Cytokinetics’ compounds that could slow or prevent clinical development or product approval, and including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, that patient enrollment for or conduct of clinical trials may be difficult or delayed, that Cytokinetics’ compounds may have adverse side effects or inadequate therapeutic efficacy, that the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials, and that Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen’s decisions with respect to the design, conduct and timing of development activities for CK-1827452; Amgen may alter or terminate its development activities for CK-1827452; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain the additional funding necessary to conduct development of some or all of its compounds; standards of care may change rendering Cytokinetics’ compounds obsolete; others may introduce products or alternative therapies for the treatment of indications Cytokinetics’ compounds may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.
CONTACT: Cytokinetics, South San Francisco Chris Keenan, Director Investor Relations & Media 650-624-3026 or 415-505-2581 (mobile) CONTACT: Amgen, Thousand Oaks Mary Klem, 805-447-6979 or 805-341-0687 (mobile) (Media) Arvind Sood, 805-447-1060 (Investors)