LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, today announced that it has reached agreement
with the U.S. Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) for the planned Phase III clinical trial of
the Company's lead drug candidate PB272 (neratinib) in patients with
HER2-positive metastatic breast cancer who have failed two or more prior
treatments (third-line disease). The SPA is a written agreement between
the Company, as the trial's sponsor, and the FDA regarding the design,
endpoints and planned statistical analysis approach of the Phase III
trial to be used in support of a New Drug Application (NDA) for PB272.
The European Medicines Agency (EMA) has also provided follow-on
scientific advice (SA) consistent with that of the FDA regarding the
Company's Phase III trial design and endpoints to be used and the
ability of such design to support the submission of a European Union
(EU) Market Authorization Application (MAA).
Pursuant to the SPA and SA, the Phase III trial will be a randomized
trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with
third-line HER2-positive metastatic breast cancer. The trial is expected
to enroll approximately 600 patients who will be randomized (1:1) to
receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial will
be conducted at approximately 150 sites in North America, Europe and
Asia-Pacific. The agreed upon co-primary endpoints of the trial are
progression-free survival and overall survival. The Company plans to use
the progression-free survival data from the trial as the basis for
submission of an NDA/MAA for Accelerated/Conditional Approval for PB272
from the regulatory agencies. Puma anticipates that it will begin
patient enrollment in this Phase III trial in March or April of this
year.
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, "Obtaining FDA and EMA agreement on the overall
Phase III trial design, and more specifically patient population and
primary endpoints, represents an important milestone in the global
development of PB272 and for Puma as a company. We look forward to
initiating patient enrollment in the Phase III trial shortly."
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 (neratinib), an oral
potent irreversible tyrosine kinase inhibitor, for the treatment of
patients with HER2-positive metastatic breast cancer and non-small cell
lung cancer.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements that 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 its lead drug candidate, 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
from time to time in the Company's filings with the Securities and
Exchange Commission, including the Company’s Quarterly Report on Form
10-Q for the Quarter Ended September 30, 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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