Attached files
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8-K - PDL BIOPHARMA, INC. | v207674_8k.htm |
Contacts: | |
Cris
Larson
PDL BioPharma, Inc.
775-832-8505
Cris.Larson@pdl.com
|
Jennifer
Williams
Cook Williams Communications, Inc.
360-668-3701
jennifer@cwcomm.org
|
PDL
BioPharma Announces Decisions on Summary Judgment
in
its Litigation with MedImmune
INCLINE
VILLAGE, NV, January 10, 2011 – PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) today
announced that on January 7, 2011, the United States District Court for the
Northern District of California issued a summary judgment order deciding certain
issues favorably and other issues adversely to PDL in its litigation with
MedImmune. PDL disagrees with certain aspects of the court’s
decisions which are adverse to the Company and is evaluating its legal options,
including appeal of these decisions. The sole patent claim at issue
in the MedImmune litigation does not cover the products currently marketed by
Genentech/Roche.
Specifically,
the court ruled that:
1) The
sole patent claim that PDL has asserted in the litigation as the basis on which
MedImmune’s product Synagis®
infringes PDL’s patent rights, Claim 28 of Queen et al., United States Patent
No. 6,180,370, is invalid as anticipated by prior art;
2) MedImmune
did not breach its obligations under its license agreement with PDL by failing
to pay royalties on sales of Synagis by its exclusive ex-US distributor,
Abbott;
3) MedImmune
is not entitled to recoup from PDL royalties on sales of Synagis that MedImmune
paid based on European patent rights that were ultimately revoked;
and
4) A
jury must decide on PDL’s claim that MedImmune breached its license agreement by
demanding that PDL consent to commercially unreasonable and contractually
insupportable conditions to permit an audit of sales and revenue associated with
Synagis by an independent accountant.
A jury
trial that had been scheduled to commence in January of 2011 was previously
postponed by the court in December 2010. A new trial date is expected
to be set shortly.
In the
event that MedImmune prevails on its most favored licensee claim in the
litigation, the Company expects that MedImmune will request the court to order
PDL to repay some or all of the royalty payments previously made to PDL under
MedImmune’s license to the Queen et al. patents. MedImmune has paid
PDL more than $280 million in royalties under the MedImmune agreement from 1998
through the end of 2009. MedImmune did not pay PDL royalties in
2010. PDL has previously disclosed revenue guidance for the full year
ended December 31, 2010 of $345 million which does not include any revenues from
MedImmune.
About
PDL BioPharma
PDL
pioneered the humanization of monoclonal antibodies and, by doing so, enabled
the discovery of a new generation of targeted treatments for cancer and
immunologic diseases. PDL is focused on maximizing the value of its antibody
humanization patents and related assets. The Company receives royalties on sales
of a number of humanized antibody products marketed by leading pharmaceutical
and biotechnology companies today based on patents which expire in late 2014.
For more information, please visit www.pdl.com.
NOTE: PDL
BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma,
Inc.
Forward-looking
Statements
This
press release contains forward-looking statements. Each of these forward-looking
statements 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:
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·
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The
expected rate of growth in royalty-bearing product sales by PDL’s existing
licensees;
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·
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The
relative mix of royalty-bearing Genentech products manufactured and sold
outside the U.S. versus made or sold in the
U.S.;
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·
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The
ability of our licensees to receive regulatory approvals to market and
launch new royalty-bearing products and whether such products, if
launched, will be commercially
successful;
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·
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Changes
in any of the other assumptions on which PDL’s projected royalty revenues
are based;
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·
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The
outcome of pending litigation or
disputes;
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·
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The
change in foreign currency exchange rate;
and
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·
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The
failure of licensees to comply with existing license agreements, including
any failure to pay royalties due.
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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 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
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.
###