NDA Filing Currently Anticipated for Q1 2016
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, today provided an update on the timeline for
filing its New Drug Application (NDA) for the approval of PB272
(neratinib) in the extended adjuvant treatment of HER2-positive early
stage breast cancer.
Puma had previously communicated that it anticipated filing the NDA for
PB272 in the first half of 2015. This was based on the feedback it had
previously received from regulatory agencies, which had been focused on
the proposed clinical indication of HER2-positive metastatic breast
cancer. Since the Company’s initial NDA filing will now be for the
extended adjuvant HER2-positive early stage breast cancer indication,
based on the company’s recent meetings with the U.S. Food and Drug
Administration (FDA), Puma will need to submit data from preclinical
carcinogenicity studies with its NDA filing in accordance with
International Conference on Harmonization (ICH) guidelines. In order to
accommodate this requirement, Puma intends to delay its proposed
timeline for filing the NDA until the first quarter of 2016.
Conference Call and Webcast
The Company will host a conference call to discuss the NDA filing
timeline update at 2:00 p.m. PST (5:00 p.m. EST) on Tuesday, December 2,
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 anticipated timing with respect to plans to file
for regulatory approval. 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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