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Cytokinetics, Incorporated
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Burns
McClellan, Inc.
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Clay Kramer
(investors)
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EVP,
Corporate Development and Commercial Operations &
CBO
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Justin
Jackson (media)
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(212) 213-0006
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CYTOKINETICS AND GLAXOSMITHKLINE
AMEND COLLABORATION AGREEMENT FOR SB-743921
Maturation of
Cytokinetics’ Capabilities Enables Increased
Responsibility
for Clinical Development under Augmented Development Program for
KSP Inhibitors
South San
Francisco, CA, September 27, 2005 —
Cytokinetics, Incorporated (Nasdaq:
CYTK) announced the amendment of the company’s strategic
alliance with GlaxoSmithKline (GSK), which will provide
Cytokinetics an expanded role in clinical research and development
for SB-743921, a novel, small molecule inhibitor of kinesin spindle
protein (KSP). This drug candidate is being developed under an
alliance focused on novel small molecule therapeutics targeting
human mitotic kinesins for applications in the treatment of cancer
and other diseases.
Under the terms
of the amendment, Cytokinetics will lead and fund development
activities to explore the potential application of SB-743921 for
the treatment of non-Hodgkin’s lymphoma, Hodgkin’s
lymphoma and multiple myeloma, subject to the option for GSK to
resume responsibility for development and commercialization
activities for SB-743921 for these indications during a defined
period. Cytokinetics’ development activities will be
conducted in parallel with GSK’s conduct of development
activities for SB-743921 in other indications and for
ispinesib (SB-715992). Ispinesib is the first drug
candidate to emerge from the strategic alliance and is currently
the subject of a broad clinical trials program pursuant to the
alliance.
The amendment
provides for acceleration of the formation of a Joint Development
Committee to oversee the conduct of all development activities
conducted by Cytokinetics and GSK for SB-743921 and for the
exercise of Cytokinetics’ option to co-fund certain later
stage development costs for this drug candidate. In addition to the
payments that GSK may make to Cytokinetics under the original terms
of the collaboration agreement, based on Cytokinetics’
expanded role under the amendment in the development of SB-743921,
Cytokinetics may receive additional pre-commercialization payments
from GSK based on the achievement of certain milestones for
SB-743921 for the additional indications described above and
increased royalties from GSK on net sales of products containing
SB-743921 under certain scenarios.
“The
expanded role to be played by Cytokinetics in the joint development
of SB-743921 with GSK reflects the maturation of
Cytokinetics’ capabilities in the area of clinical research
and development since the initiation of the collaboration in
June 2001,” stated Robert I. Blum, Executive Vice
President, Corporate Development and Commercial Operations and
Chief Business Officer. “We have evolved as a company,
increasing the resources that we can bring to bear on development
activities now being directed to this program. We look forward to
the initiation of a clinical trial for SB-743921 in
non-Hodgkin’s lymphoma in the coming
months.”
SB-743921
entered a Phase I clinical trial conducted by GSK in the United
States in May 2004 to evaluate its tolerability and
pharmacokinetics in advanced cancer patients. Data relating to
SB-743921 were presented at the 2005 Annual Meeting of the American
Society of Clinical Oncology in May 2005. The data presented
were from 20 patients that collectively had a variety of advanced
solid tumors and received doses of SB-743921 intravenously once
every 21 days. SB-743921 appears to have an acceptable
tolerability profile for patients suffering from advanced solid
tumors. The dose-limiting toxicities observed to date are prolonged
neutropenia, febrile neutropenia (with or without infection),
elevated transaminases, hyperbilirubinemia and hyponatremia.
Notably, neurotoxicities, mucositis, thrombocytopenia, alopecia and
nausea/vomiting requiring pre-medication have not been observed to
date.
“We are
excited about investigating new potential therapeutic indications
for SB-743921, augmenting the efforts of our partner in evaluating
KSP inhibitors for their potential in the treatment of patients
with various cancers,” stated Andrew A. Wolff, M.D.,
F.A.C.C., Senior Vice President, Clinical Research and Development
and Chief Medical Officer. “Our working in parallel with GSK
in development of SB-743921 is consistent with the original intent
of our alliance to explore the full breadth of the therapeutic
potential of our drug candidates. SB-743921 is the second KSP
inhibitor to enter clinical trials under our collaboration and has
distinct clinical potential that we believe warrants exploration in
additional tumor types.”
- more -
Cytokinetics
Joint Development of SB-743921 Announcement
Page 2
Research
& Development Expense Guidance for 2005
The financial
impact of this amendment will not result in an increase in
Cytokinetics’ research and development expense guidance for
2005. The guidance previously provided for research and development
expenses for 2005 is $45 to $49 million.
Conference
Call / Webcast
Cytokinetics
will host a conference call on Tuesday, September 27, 2005 at
6:00 p.m. Eastern Time. The conference call will be simultaneously
webcast and will be accessible in t
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