FREMONT, Calif., Aug. 3 /PRNewswire-FirstCall/ -- PDL BioPharma, Inc.
(PDL) (Nasdaq: PDLI) today announced that a double-blind,
placebo-controlled, Phase 3 clinical study of terlipressin, a vasoactive
peptide, did not meet its primary endpoint in the treatment of type 1
hepatorenal syndrome (HRS), a life-threatening complication of advanced
liver disease characterized by rapidly progressive kidney failure. In this
study, the primary endpoint was treatment success, defined as the
percentage of patients alive at Day 14 who demonstrated reversal of type 1
HRS, based upon two measurements of serum creatinine levels less than or
equal to 1.5 mg/dL without dialysis or recurrence of disease. The data
showed a positive trend toward treatment success, but did not reach
statistical significance.
"We are disappointed that the trial of terlipressin did not meet its
primary endpoint, as there is a substantial unmet need in HRS," said Steven
Benner, M.D., Chief Medical Officer, PDL. "We will work with Orphan
Therapeutics to further analyze the study results."
PDL obtained U.S. commercial rights to terlipressin following its
acquisition of ESP Pharma in March 2005. The original agreement between ESP
Pharma and Orphan Therapeutics was established in June 2004.
Peter Teuber, Ph.D., President of privately-held Orphan Therapeutics,
said, "We applaud the investigator community for their support and
participation in this important clinical trial for a disease that has a
serious unmet medical need. Although the primary endpoint showed only a
trend towards improvement, I am encouraged by other results and look
forward to reviewing the data with the Food and Drug Administration."
This Phase 3 study, conducted by Orphan Therapeutics, was the first
randomized, double-blind, placebo-controlled clinical trial of terlipressin
in type 1 HRS in the United States. The study, which evaluated the safety
and the potential effect of terlipressin on kidney function and survival in
patients with type 1 HRS, enrolled 112 patients at 30 liver disease centers
in the United States and five centers outside the United States. Patients
were randomized to receive terlipressin or placebo every six hours until a
reversal of HRS was seen or for up to 14 days.
About PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on
discovering, developing and commercializing innovative therapies for severe
or life- threatening illnesses. The company currently markets and sells a
portfolio of leading products in the acute-care hospital setting in the
United States and Canada and generates royalties through licensing
agreements with top-tier biotechnology and pharmaceutical companies based
on its pioneering antibody humanization technology. Currently, PDL's
diverse late-stage product pipeline includes six investigational compounds
in Phase 2 or Phase 3 clinical development for hepatorenal syndrome,
inflammation and autoimmune diseases, cardiovascular disorders and cancer.
The company's research platform is focused on the discovery and development
of antibodies for the treatment of cancer and autoimmune diseases. For more
information, please see PDL's website at http://www.pdl.com.
Forward-looking Statements
The information in this press release should be considered accurate
only as of the date of the release. PDL has no intention of updating and
specifically disclaims any duty to update the information in this press
release for any reason, except as required by law, even as new information
becomes available or other events occur in the future. This press release
may contain "forward-looking statements" that are based on current
expectations and assumptions that are subject to risks and uncertainties.
The actual results may differ materially from those in the forward-looking
statements because of various factors, risks and uncertainties, including
in particular the outcome of further analysis and discussions with the FDA.
For further information regarding factors, risks and uncertainties that may
cause such differences, please refer to the filings PDL has made with the
Securities and Exchange Commission, including the "Risk Factors" sections
of PDL's Quarterly and Annual Reports, copies of which may be obtained at
the "Investors" section on PDL's website at http://www.pdl.com. All
forward-looking statements in this press release are qualified in their
entirety by this cautionary statement.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered
trademarks of PDL BioPharma, Inc.
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, or ami.knoefler@pdl.com, or Jean
Suzuki, Product Communications, +1-510-574-1550, or
jean.suzuki@pdl.com, both of PDL BioPharma, Inc.
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