LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE:PBYI), a development stage
biopharmaceutical company, announced an amendment to its licensing
agreement with Pfizer for Puma's investigational drug PB272 (neratinib).
Puma is currently developing PB272 for the treatment of patients with
HER2-positive breast cancer and patients with non-small cell lung
cancer, breast cancer and other solid tumors that have a HER2 mutation.
At the time that Puma licensed PB272 from Pfizer, a number of ongoing
clinical trials (legacy clinical trials) that had been previously
initiated by Pfizer were transferred to Puma. The original license
agreement set a limit on the amount of external expenses that Puma would
incur in completing these legacy clinical trials. Puma reached this
limit in the fourth quarter of 2012. The original license agreement also
provided that Pfizer would be responsible for all expenses for these
ongoing legacy trials above the pre-determined limit until the trials
were completed.
The amendment to the license agreement provides that Puma will now be
solely responsible for the expenses associated with the ongoing legacy
clinical trials. Puma anticipates that this will result in an increase
in research and development expenses, which will total approximately $30
million. Puma further anticipates that a significant percentage of this
approximately $30 million will occur in 2014 and will decrease over time
until the trials are completed.
In addition, according to the terms of the original license agreement,
upon commercialization of neratinib, Puma is obligated to pay Pfizer
incremental annual royalties ranging between 10 to 20 percent of net
sales of neratinib. Under the terms of the amendment to the license
agreement, upon commercialization of neratinib, Puma will be obligated
to pay Pfizer annual royalties on net sales of neratinib at a fixed rate
in the low- to mid- teens.
“We are pleased to enter into this amendment to the licensing agreement
for neratinib. By assuming responsibility for the expenses associated
with the ongoing legacy clinical trials, and by fixing the royalty rate
for the drug at a reduced rate, we believe that we have significantly
improved the potential value of the drug,” said Alan H. Auerbach, Chief
Executive Officer and President.
Conference Call and Webcast
Puma Biotechnology will host a conference call to discuss the amendment
to the license agreement for neratinib at 2:00 p.m. PDT (5:00 p.m. EDT)
on Tuesday, July 22, 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 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 anticipated increases in, the timing of the
increases in and the decrease over time in research and development
expenses. 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 has no product revenue and no
products approved for marketing; the Company’s dependence on PB272,
which is still under development and may never receive regulatory
approval; the challenges associated with conducting and enrolling
clinical trials; the risk that the results of clinical trials may not
support the Company’s drug candidate claims; even if approved, the risk
that physicians and patients may not accept or use the Company’s
products; the Company’s reliance on third parties to conduct its
clinical trials and to formulate and manufacture its drug candidates;
the Company’s dependence on licensed intellectual property; 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, 2013. 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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