- Company Plans Sale of Commercial Operations -
- Nuvion(R) Pivotal Trial Program Terminated -
- Company Plans Organizational Realignment -
FREMONT, Calif., Aug. 28 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(PDL) (Nasdaq: PDLI) today announced a significant strategic change to
focus the company on the discovery and development of novel antibodies in
oncology and select immunological diseases, following a months-long
business and portfolio review.
As a result of this new strategic focus, which does not include
cardiovascular disease, PDL plans to sell its commercial assets, including
its Cardene(R), Retavase(R) and IV Busulfex(R) products, as well as the
ularitide development-stage cardiovascular product. Separately, following a
recent and routine Data Monitoring Committee (DMC) evaluation of data from
the ongoing RESTORE 1 pivotal trial, the company has decided to terminate
the Nuvion (visilizumab) phase 3 program in ulcerative colitis due to
insufficient efficacy and an inferior safety profile in the visilizumab arm
compared to IV steroids alone. In light of these developments, the company
will realign its organization this Fall to support its new strategy.
The company will hold a conference call on Tuesday, August 28th at 5:15
pm ET to discuss these decisions and respond to questions. A webcast of the
conference call will be available through the PDL website:
http://www.pdl.com.
"We believe our planned strategic shift, which leverages our core
technical strengths and expertise in monoclonal antibodies as a
development-stage company, is in the best long-term interests of our
stockholders," said L. Patrick Gage, Ph.D., executive chairman of PDL's
board of directors. "Although we're surprised and disappointed by the
Nuvion results in IVSR-UC, we're fortunate to have a portfolio of multiple
candidates consistent with our longer-term focus in the targeted areas of
oncology and immunology, as well as sufficient resources to advance these
opportunities."
Nuvion (visilizumab) Pivotal Program Termination
Following review of data communicated by the Nuvion DMC this past
Friday, August 24, PDL has decided that it will no longer pursue its phase
3 program of visilizumab in IVSR-UC, including both the RESTORE 1 and
RESTORE 2 studies. The DMC interim evaluation included data from 91
patients in the RESTORE 1 trial at the 45-day primary endpoint. The
analysis showed insufficient efficacy and an inferior safety profile in the
visilizumab arm compared to IV steroids alone. The company is currently
reviewing whether to continue the ongoing dose-ranging trial while it
thoroughly evaluates the broader implications of these very recent results
to the overall visilizumab program.
New Strategic Direction and Organizational Alignment
PDL has revised its corporate strategy to take advantage of its deep
clinical and pre-clinical portfolio, and leverage its ability to innovate
in the science and development of monoclonal antibodies. PDL will focus its
research and development initiatives and strengthen its expertise in two
therapeutic areas -- oncology and select immunological diseases. In
oncology, the company's programs include volociximab in a number of solid
tumors, HuLuc63 in multiple myeloma, PDL 192 in preclinical development and
several additional research stage candidates. PDL's immunological programs
include daclizumab in multiple sclerosis and other indications, visilizumab
in various potential indications and several preclinical candidates. The
company is planning a research and development update in mid-November to
detail the status of its R&D initiatives.
Based primarily on its strategic shift to focus on discovery and
development of antibodies in oncology and select immunological diseases,
PDL is conducting a thorough review of its organization, and anticipates a
sizeable workforce reduction, to ensure that its structure and scope of
operations are appropriately aligned with the new strategy.
Planned Sale of Commercial Operations
Given the change in strategic direction of the company and current
timing of its pipeline, the company has determined that its commercial
products and cardiovascular development programs are no longer a strategic
fit.
As a result, the company has engaged Merrill Lynch & Co. to advise it
on the sale of the rights to Cardene, Retavase, IV Busulfex and ularitide,
and related assets, in one or more transactions. The company is seeking to
retain staff in approximately 250 positions that support its commercial and
cardiovascular products through the completion of the planned sale(s), but
expects to eliminate these positions in connection with the sales of the
company's commercial assets, which would be in addition to the workforce
reduction anticipated in connection with aligning the organization to the
company's new strategy. PDL has not finalized its plans for the optimal use
of proceeds from the sale of these assets, but will provide updates on
these and other financial options at the appropriate time. The company
anticipates that its earnings will be significantly reduced in the near
term following the sale of the marketed products, which generated $187.2
million in revenues in the 12 months ended June 30, 2007. Given the
uncertain timing of and charges related to the planned transaction(s) and
overall realignment, the company has suspended its financial guidance for
2007.
"Our marketed products have been an important component of the
financial value of PDL, but they simply no longer fit with our new
direction and timeline for commercialization of our internal development
products. These products, and our valued employees who have supported them,
have contributed to the company's revenue and cash flow growth in recent
years," said Mark McDade, PDL's chief executive officer. "We believe we
have created significant value in these important products and the
supporting operations, and we're now looking for the right buyer that can
build upon this value that has been created by PDL, while we move forward
with implementation of our new strategic direction."
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on
discovering, developing and commercializing innovative therapies for severe
or life-threatening illnesses. For more information, please visit
http://www.pdl.com.
Forward-looking Statements
This press release contains forward-looking statements, including
regarding PDL's plans to change its strategic focus; sell its commercial
assets, including its Cardene, Retavase and Busulfex product rights, and
ularitide development-stage cardiovascular product; an anticipated
workforce reduction; and the advancement of PDL's clinical antibody
pipeline, each of which involves risks and uncertainties. Actual results
may differ materially from those, express or implied, in these
forward-looking statements. Factors that may cause differences between
current expectations and actual results include, but are not limited to,
the following: additional developments or decisions could cause PDL to
alter its strategic focus; PDL may not be able to negotiate the sale of its
commercial assets on terms acceptable to it; the consummation of any sale
of commercial assets, even if on acceptable terms, could be adversely
impacted or prevented by failure to satisfy closing conditions or
regulatory delays; and PDL's success in advancing its pipeline could be
adversely affected by failure or delay of clinical development programs,
including because of delays in contracting with clinical sites, enrollment
rates, availability of clinical materials or safety or manufacturing
issues, adverse market conditions, failure to develop, protect or license
intellectual property rights, failure to retain key employees and increased
competition. Other factors that may cause PDL's actual results to differ
materially from those expressed or implied in the forward-looking
statements in this press release are discussed in PDL's filings with the
Securities and Exchange Commission (SEC), including the "Risk Factors"
sections of its annual and quarterly reports filed with the SEC. Copies of
PDL's filings with the SEC may be obtained at the "Investors" section of
PDL's website at http://www.pdl.com. PDL expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in PDL's
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based for any reason, except
as required by law, even as new information becomes available or other
events occur in the future. All forward-looking statements in this press
release are qualified in their entirety by this cautionary statement.
SOURCE PDL BioPharma, Inc.
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Related links:
http://www.pdl.com
CONTACT:
Ami Knoefler, Corporate and Investor
Relations, +1-510-284-8851, ami.knoefler@pdl.com, or Jean Suzuki,
Investor Relations, +1-510-574-1550, jean.suzuki@pdl.com, or
Kathleen Rinehart, Corporate Communications, +1-510-574-1480,
kathleen.rinehart@pdl.com, all of PDL BioPharma, Inc.
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