Full Press Release Details
Pharmaceuticals Focuses Resources on Development of
Leadership Team in Place to Advance Voreloxin to Late-Stage
Realignment Includes Workforce Reduction to Streamline
San Francisco, CA June 3, 2008 -
Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced a corporate realignment
focus on the development of the company's lead oncology product candidate,
voreloxin (formerly SNS-595). In conjunction with this strategic restructuring,
Sunesis expanded the company's late-stage development leadership team and
announced a workforce reduction of approximately 60 percent, including the
winding down of its research activities. These changes are intended to
concentrate the company's financial and human resources on the strongest path to
potential near-term value creation for the company's stockholders.
the promising clinical data achieved to date, we have made a strategic decision
to focus the organization on generating critical clinical data by advancing
lead compound, voreloxin, into late-stage trials in the acute myeloid leukemia
and ovarian cancer indications," said Daniel Swisher, Sunesis' Chief Executive
Officer. "Late-stage development requires increased focus of our resources. We
are also expanding and strengthening our development team with the additions
Drs. Steve Ketchum and Mary Bolton. Their extensive product development and
regulatory expertise and track records of successful FDA submissions in a
breadth of therapeutic areas will support our plan to advance voreloxin through
Ketchum, Ph.D., has been appointed as Senior Vice President, Research and
Development and Mary G. Bolton, M.D., Ph.D., as Vice President, Clinical
Development. In addition, Judith A. Fox, Ph.D., has been promoted to Vice
President, Product and Preclinical Development and Glenn C. Michelson, M.D.,
been promoted to Vice President, Clinical Strategy.
voreloxin has demonstrated objective responses in both solid and hematologic
tumors and has been consistently well tolerated in multiple clinical trials.
Sunesis is currently conducting Phase 2 clinical trials of voreloxin as a single
agent for the treatment of platinum-resistant ovarian cancer and previously
untreated acute myeloid leukemia (AML), as well as a Phase 1b clinical trial
voreloxin in combination with cytarabine in relapsed/refractory AML. Data
recently reported at the 44th
Annual Meeting in the Phase 2 ovarian cancer trial demonstrated that 48 percent
of platinum-resistant ovarian cancer patients treated at a dose of 48
every 21 days achieved disease control, defined as stable disease for 90 days
more or a complete or partial response. Preliminary median progression-free
survival in this group of patients was 13 weeks at this dose; twenty-three
patients at this dose remained on study as of May 12, 2008. Later this month,
the European Hematology Association Congress, Sunesis will report updated data
on voreloxin's activity alone, and interim data on voreloxin's activity in
combination with cytarabine for the treatment of AML.
continues ongoing trials in its earlier-stage clinical programs, including
Phase 1 dose-escalation study of its cyclin-dependent kinase inhibitor, SNS-032,
and its pan-Aurora kinase inhibitor, SNS-314, and expects to report data from
these clinical trials this year. The company plans to seek a development partner
to support advanced clinical trials of SNS-314. Future development of SNS-032
will depend on achieving positive results from the ongoing trial.
closing of its internal discovery research activities, Sunesis will also explore
opportunities to monetize the company's extensive fragment-based drug discovery
capabilities, its preclinical programs and/or its intellectual property
portfolio through a potential spin out or strategic alliance.
will continue to benefit from any down-stream milestones or royalties based
future progress made in compounds emerging from its existing drug discovery
collaborations with Biogen Idec Inc., Johnson & Johnson Pharmaceutical
Research and Development LLC, Merck & Co., Inc. and SARcode Corporation.
Sunesis anticipates that one or more of these compounds may advance to clinical
trials within the next twelve months.
restructuring, Sunesis is reducing its workforce by approximately 60 employees.
In addition, executive team members Daniel C. Adelman, M.D., Senior Vice
President, Development and Chief Medical Officer, William L. Schary, Ph.D.,
President, Regulatory Affairs and Quality Assurance, Robert S. McDowell, Ph.D.,
Vice President, Research and Jennifer A. Troia, SPHR, Vice President, Human
Resources and Corporate Operations, will be leaving the company. Employees
affected by the restructuring will be eligible for a severance package that
includes severance pay, continuation of benefits and professional outplacement
services. A one-time charge of approximately $10.7 million is expected to be
incurred in the second quarter of 2008. Approximately $8.0 million of this
charge is related to the closing of the company's research facility.
Approximately $2.5 million of the restructuring charge represents cash payments
over the next twelve months for severance and other personnel related expenses.
decision to undertake this workforce reduction is a difficult one. I deeply
appreciate all of the past contributions made on behalf of Sunesis by the
talented and committed employees affected by this realignment. I am confident
that the ongoing team will build upon their legacy as we aggressively advance
voreloxin through late-stage clinical studies," said Mr. Swisher.
taken today will allow the company to direct most of its resources into the
late-stage development of voreloxin. Sunesis expects this realignment of
personnel and programs to reduce annual operating expenses by more than $15
million, thus enabling increased investment into such development. Current
rate guidance for the second half of 2008 is in the range of $12-15 million,
including payment of severance and other restructuring charges.
Voreloxin (formerly SNS-595)
lead compound, voreloxin (formerly SNS-595), is a novel naphthyridine analog,
structurally related to quinolones, a class of compounds which has not been
previously for the treatment of cancer. Voreloxin both intercalates DNA
and inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, irreversible G2 arrest and rapid apoptosis. Voreloxin
is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1
trial) in previously untreated elderly AML patients, in a Phase 1b clinical
trial combining voreloxin with cytarabine for the treatment of patients with
relapsed/refractory AML, and as a single agent in a Phase 2 clinical trial
platinum-resistant ovarian cancer. In clinical trials conducted to date,
voreloxin has been generally well tolerated and has shown objective responses
both solid and hematologic tumor types.
Sunesis Pharmaceuticals
is a clinical-stage biopharmaceutical company focused on the development of
oncology therapeutics for the treatment of solid and hematologic cancers.
Sunesis has built a highly experienced cancer drug development organization
committed to advancing its lead product candidate, voreloxin, in multiple