Patent Claims for Treating Cancer with T790M Mutation Upheld
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced that the European Patent Office has
upheld the claims in Puma’s licensed European patent (EP 1848414) which
were being opposed by Boehringer Ingelheim International GmbH.
The intellectual property portfolio that was licensed from Pfizer in
2011 when Puma licensed neratinib included issued patents in a number of
countries including Europe (EP 1848414) as well as pending patent
applications in several countries including the United States relating
to methods of treating gefitinib and/or erlotinib resistant cancer. More
specifically, the patent that was issued in Europe in April 2011
included specific claims that included a pharmaceutical composition for
use in treating cancer in a subject with a cancer having a mutation in
EGFR with a T790M mutation. On November 28, 2011, Boehringer Ingelheim
International GmbH filed an opposition to this patent asking for this
patent to be revoked.
The Oral Proceedings of the European Patent Office were held in Munich,
Germany on February 4, 2014. The decision of the European Patent Office
was to uphold the granted claims of the European patent that relate to
the T790M mutation without any modification. This included specific
claims that include 1) claims for the pharmaceutical composition
comprising an irreversible EGFR inhibitor for use in treating cancer in
a subject having a T790M mutation; and 2) claims for the pharmaceutical
composition for use in the treatment of numerous cancers, including lung
cancer and non-small cell lung cancer.
“We are very pleased with the outcome of the opposition proceedings and
more specifically that the claims related to the T790M mutation have
been upheld,” said Alan H. Auerbach, Chief Executive Officer and
President of Puma. “Although we have no plans to develop neratinib in
cancers with a T790M mutation, we recognize the value of this important
patent in our overall patent estate and in the T790M landscape and we
are committed to strengthening our patent portfolio for the Company. We
look forward to the continued advancement of this patent portfolio for
T790M in other countries and the potential benefit that it may bring to
the Company.”
Conference Call and Webcast
The Company will host a conference call to discuss the positive outcome
of the European Opposition Proceedings at 2:00 p.m. PST (5:00 p.m. EST)
on February 6, 2014.
The conference call may be accessed by dialing 1-877-709-8150 for
domestic callers and 1-201-689-8354 for international callers. Please
specify to the operator that you would like to join the “Puma
Biotechnology Update Call.” The conference call will also be webcast
live and accessible through the Investor Relations section of Puma’s
website at http://www.pumabiotechnology.com/ir_events.html
and will be archived there for 30 days following the call. Please visit
Puma’s website several minutes prior to the start of the broadcast to
ensure adequate time for any software download that may be necessary.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical
company that acquires and develops innovative products for the treatment
of various forms of cancer. The Company focuses on in-licensing drug
candidates that are undergoing or have already completed initial
clinical testing for the treatment of cancer and then seeks to further
develop those drug candidates for commercial use. The Company is
initially focused on the development of PB272 (oral neratinib), a potent
irreversible tyrosine kinase inhibitor, for the treatment of patients
with HER2-positive metastatic breast cancer and patients with non-small
cell lung cancer, breast cancer and other solid tumors that have a HER2
mutation.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements, including
statements regarding the Company’s development plans. All
forward-looking statements included in this press release involve risks
and uncertainties that could cause the Company's actual results to
differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are
based on current expectations, forecasts and assumptions, and actual
outcomes and results could differ materially from these statements due
to a number of factors, which include, but are not limited to, the fact
that the Company’s proprietary rights may not adequately protect its
intellectual property, intellectual property rights are complicated and
continuously evolving, coverage of patents is subject to interpretation
by courts and this is not always consistent, defending the patentability
of patents and patent applications, and defending against claims that
the Company infringes third-party patents, can be expensive and time
consuming, and the other risk factors disclosed in the periodic reports
filed by the Company with the Securities and Exchange Commission from
time to time, including the Company’s Annual Report on Form 10-K
for the year ended December 31, 2012. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.
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