Sfbc (NASDAQ:SFCC)
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SFBC International, Inc. (NASDAQ: SFCC), a provider of
drug development services to branded pharmaceutical, biotechnology,
generic drug and medical device companies, announced today key
initiatives implemented by Jeffrey P. McMullen, who was recently
appointed chief executive officer of SFBC International.
SFBC is relocating its corporate headquarters from its current
location in Miami, Florida, to Princeton, New Jersey, the headquarters
of PharmaNet, SFBC's late-stage development division. SFBC will
continue to provide early stage clinical trial services and operate
its clinical laboratory at its research facility in Miami. Concurrent
with the relocation of the corporate headquarters, David Natan, vice
president of finance and chief financial officer, will transition the
role and responsibilities of CFO of SFBC International to John P.
Hamill, vice president of finance and CFO of PharmaNet, over a period
of the next six to nine months. In addition to Mr. Hamill's future
role of CFO of SFBC, he has been promoted to senior vice president and
CFO of PharmaNet. After the transition, Mr. Natan will be promoted to
senior vice president of financial analysis and reporting. In
addition, PharmaNet has promoted four key members of the Executive
Committee, including Thomas J. Newman, MD, to executive vice president
and chief operating officer of PharmaNet; Robert Reekie, MD, to
executive vice president, operations, Europe and Australasia; Dalvir
Gill, PhD, to executive vice president, U.S. clinical research; and
Sean P. Larkin to executive vice president, late phase development.
Additional biographical information about these executives is
available on PharmaNet's Website at www.pharmanet.com.
Following a preliminary review of SFBC's operations, Mr. McMullen
established two internal strategic task forces:
-- A Regulatory task force led by Gregory M. Hockel, PhD,
PharmaNet's senior vice president of regulatory affairs
worldwide, is responding to an open item with regard to an
inspection by the U.S. Food and Drug Administration of SFBC's
Miami facility. SFBC is working with the client and the FDA to
clarify information regarding one study. The information
addresses concerns raised by the agency's Division of
Scientific Investigations regarding the number of evaluators
and the timing of the assessments used in the study. The task
force will continue working closely and openly with all
parties in an attempt to get these issues resolved. It is
important to note that no warning letter has been issued.
-- A building task force is working with Miami-Dade County
representatives to address the previously announced concerns
about the structural and related issues at its facility and
prepare for the upcoming Miami-Dade County Building Department
hearing scheduled for January 18, 2006. In addition, based on
SFBC's existing capacity throughout its North American
facilities and its previously announced plan to open a new
150-bed Phase I facility in Toronto, Ontario by the end of the
second quarter of 2006, the Company is reassessing the need
for utilizing SFBC's other Miami site that was previously
operated as a Phase I clinic by Clinical Pharmacology
Associates (CPA), which was acquired by SFBC in August 2003.
In addition, the Company's independent legal counsel will respond
to an informal, non-public request from the U.S. Securities and
Exchange Commission for records primarily relating to the duties,
compensation and expenses of two former employees, Lisa Krinsky and
Gerald Seifer. SFBC intends to fully cooperate regarding this request.
Jeffrey P. McMullen, chief executive officer of SFBC
International, commented, "We are intent on building upon the strong
platform of the Company, aggressively addressing the issues
confronting us and moving the organization forward to achieve our
objectives. I am also committed to providing more transparency in our
financial reporting and operating activities. These initiatives are
important steps in re-instilling confidence in our organization and
building shareholder value. Consistent with the recent executive
management changes, we believe that it is most effective to relocate
the corporate headquarters and consolidate the financial reporting for
all SFBC operations to Princeton, where the vast majority of the
Executive Committee is located. I look forward to working closely with
John and David through the transition of the CFO role and know that
both will continue to provide strong support for the future of the
company."
In addition, the Company announced that it expects the meeting
with the staff of the United States Senate Committee on Finance, and
Dr. Krinsky and Mr. Seifer to take place on January 11, 2006, as
previously requested by Senator Charles Grassley. The Company also
believes that Arnold Hantman, as well as the three SFBC employees
mentioned in the Independent Counsels' report, will be available to
meet with the Finance Committee's staff but no specific meeting date
has been set.
Mr. McMullen concluded, "I have established teams of experienced
professionals to focus on high-priority items, and we will continue
working closely and openly with all parties to get these issues
resolved. SFBC intends to cooperate fully on all matters and we
encourage everyone involved to cooperate as well."
About SFBC International, Inc.
SFBC International, Inc. provides early and late stage clinical
drug development services to branded pharmaceutical, biotechnology,
generic drug and medical device companies around the world. SFBC has
more than 30 offices located in North America, Europe (including
Central and Eastern Europe), South America, Asia, and Australia. In
early clinical development services, SFBC specializes primarily in the
areas of Phase I and early Phase II clinical trials and bioanalytical
laboratory services, including early clinical pharmacology. SFBC also
provides late stage clinical development services globally that focus
on Phase II through IV clinical trials. SFBC also offers a range of
complementary services, including data management and biostatistics,
central laboratory services, medical and scientific affairs,
regulatory affairs and submissions, and clinical IT solutions.
Additional information is available on SFBC's website at
www.sfbci.com.
Forward-Looking Statements
The statements made in this press release relating to the ability
to meet the FDA's concerns and completion of the new Toronto facility
are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 (the "Act"). Additionally
words such as "seek," "intend," "believe," "plan," "estimate,"
"expect," "anticipate" and other similar expressions are
forward-looking statements within the meaning of the Act. Some or all
of the results anticipated by these forward-looking statements may not
occur. Factors that could cause or contribute to such differences
include, but are not limited to, the inherent difficulty in predicting
how regulators may assess a set of facts and delays in completing
improvements or receiving the necessary equipment to operate the new
facility.