Amgen and Cytokinetics Announce Expansion of License for Omecamtiv Mecarbil
(Thomson Reuters ONE) -
Cytokinetics Will Receive $25 Million Plus Potential Milestone Payments and
Royalties
THOUSAND OAKS, Calif. AND SOUTH SAN FRANCISCO, Calif, (June 12, 2013) - Amgen
(NASDAQ:AMGN) and Cytokinetics Incorporated (NASDAQ:CYTK) today announced an
expansion of their strategic collaboration to include Japan. In 2006,
Cytokinetics and Amgen entered into a collaboration to discover, develop and
commercialize novel small-molecule therapeutics that activate cardiac muscle
contractility for potential applications in the treatment of heart failure.
Omecamtiv mecarbil is the most advanced drug candidate in this collaboration.
Initially, Cytokinetics' license to Amgen for omecamtiv mecarbil excluded
Japan. Under the amendment to the collaboration announced today, the companies
have agreed on terms expanding Amgen's license for omecamtiv mecarbil and
related compounds to include Japan.
In consideration of the expanded license, Cytokinetics will receive $25 million
from Amgen comprised of a non-refundable license fee of $15 million and $10
million for Amgen's purchase of Cytokinetics' common stock. The companies have
executed a stock purchase agreement providing for the sale of Cytokinetics'
common stock to Amgen 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. In addition, Cytokinetics is
eligible to receive additional pre-commercialization milestone payments for the
development of omecamtiv mecarbil in Japan of up to $50 million as well as
royalties on sales of omecamtiv mecarbil in Japan. Under the terms of the
amended collaboration agreement, Cytokinetics plans to conduct a Phase I
pharmacokinetic study, the costs of which will be reimbursed by Amgen, intended
to support the inclusion of Japanese patients in a potential Phase III clinical
development program for omecamtiv mecarbil.
"We are pleased to expand our collaboration with Amgen to include Japan," stated
Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "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. We look
forward to the integration of Japan into our collaboration's global development
plan for this promising drug candidate."
"This expanded collaboration furthers Amgen's hopes to address needs of patients
with heart failure in Japan," said Sean E. Harper, M.D., Amgen's Executive Vice
President of Research and Development.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a small molecule cardiac myosin activator which was
discovered by Cytokinetics' scientists and is the subject of a collaboration
between Cytokinetics and Amgen. It is being investigated for the treatment of
heart failure.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe, effective
medicines from lab to manufacturing plant to patient. Amgen therapeutics have
changed the practice of medicine, helping people around the world in the fight
against serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically improve
people's lives. For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
About Cytokinetics
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 other
medical conditions. Cytokinetics currently has three compounds in clinical
development: omecamtiv mecarbil in Phase II for acute and chronic heart failure,
tirasemtiv in Phase II for amyotrophic lateral sclerosis and CK-212107 in a
Phase I study in healthy volunteers. All of the company's drug candidates have
arisen from Cytokinetics' muscle biology focused research activities and are
directed towards the cytoskeleton. The cytoskeleton is a complex biological
infrastructure that plays a fundamental role within every human cell.
Additional information about Cytokinetics can be obtained at
http://www.cytokinetics.com.
Forward-Looking Statements: Amgen
This news release contains forward-looking statements that involve significant
risks and uncertainties, including those discussed below and others that can be
found in Amgen's Form 10-K for the year ended December 31, 2012, and in any
subsequent periodic reports on Form 10-Q and Form 8-K. Amgen is providing this
information as of the date of this news release and does not undertake any
obligation to update any forward-looking statements contained in this document
as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ
materially from those Amgen projects. Amgen's results may be affected by
Amgen's ability to successfully market both new and existing products
domestically and internationally, clinical and regulatory developments (domestic
or foreign) involving current and future products, sales growth of recently
launched products, competition from other products (domestic or foreign) and
difficulties or delays in manufacturing its products. In addition, sales of
Amgen products are affected by reimbursement policies imposed by third-party
payers, including governments, private insurance plans and managed care
providers and may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and healthcare cost
containment as well as U.S. legislation affecting pharmaceutical pricing and
reimbursement. Government and others' regulations and reimbursement policies
may affect the development, usage and pricing of Amgen products. Furthermore,
Amgen's research, testing, pricing, marketing and other operations are subject
to extensive regulation by domestic and foreign government regulatory
authorities. Amgen or others could identify safety, side effects or
manufacturing problems with Amgen products after they are on the market.
Amgen's business may be impacted by government investigations, litigation and
product liability claims. If Amgen fails to meet the compliance obligations in
the corporate integrity agreement between Amgen and the U.S. government, Amgen
could become subject to significant sanctions. Further, while Amgen routinely
obtains patents for its products and technology, the protection offered by its
patents and patent applications may be challenged, invalidated or circumvented
by its competitors. Amgen depends on third parties for a significant portion of
its manufacturing capacity for the supply of certain of its current and future
products and limits on supply may constrain sales of certain of its current
products and product candidate development. In addition, Amgen competes with
other companies with respect to some of its marketed products as well as for the
discovery and development of new products. Discovery or identification of new
product candidates cannot be guaranteed and movement from concept to product is
uncertain; consequently, there can be no guarantee that any particular product
candidate will be successful and become a commercial product. Further, some raw
materials, medical devices and component parts for Amgen products are supplied
by sole third-party suppliers. Amgen's business performance could affect or
limit the ability of its Board of Directors to declare a dividend or its ability
to pay a dividend or repurchase its common stock.
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' and Amgen's research and development
activities, including the planned conduct of clinical trials; the potential
receipt of milestones, royalties and other payments; and the properties and
potential benefits of omecamtiv mecarbil and Cytokinetics' other 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: Cytokinetics anticipates that it will be required
to conduct at least one confirmatory Phase III clinical trial of tirasemtiv in
ALS patients which will require significant additional funding, and it may be
unable to obtain such additional funding on acceptable terms, if at all;
potential difficulties or delays in the development, testing, regulatory
approvals for trial commencement, progression or product sale or manufacturing,
or production of Cytokinetics' drug candidates that could slow or prevent
clinical development or product approval, including risks that current and past
results of clinical trials or preclinical studies may not be indicative of
future clinical trials results, patient enrollment for or conduct of clinical
trials may be difficult or delayed, Cytokinetics' drug candidates may have
adverse side effects or inadequate therapeutic efficacy, 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 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, initiation,
conduct, timing and continuation of development activities for omecamtiv
mecarbil; Cytokinetics may incur unanticipated research and development and
other costs or be unable to obtain additional financing necessary to conduct
development of its products; Cytokinetics may be unable to enter into future
collaboration agreements for its drug candidates and programs on acceptable
terms, if at all; standards of care may change, rendering Cytokinetics' drug
candidates obsolete; competitive products or alternative therapies may be
developed by others for the treatment of indications Cytokinetics' drug
candidates and potential drug candidates 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.
Contacts:
Kristen Davis, 805-447-3008 (Amgen media)
Arvind Sood, 805-447-1060 (Amgen investors)
Joanna L. Goldstein, 650-624-3000 (Cytokinetics investors & media)
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
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Datum: 12.06.2013 - 13:30 Uhr
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News-ID 269042
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