LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company,
announced that the European Medicines Agency (EMA) has requested that
the Scientific Advisory Group on Oncology provide an opinion on the
clinical aspects of the Marketing Authorization Application (MAA) for
neratinib at a meeting to be held on January 11, 2018. In Europe,
neratinib is an investigational therapy for the extended adjuvant
treatment of early stage HER2-positive breast cancer that has previously
been treated with a trastuzumab containing regimen.
The Scientific Advisory Group on Oncology is convened at the request of
the EMA to provide independent recommendations on scientific or
technical matters related to pediatric and adult clinical oncology and
hematology, or on any other scientific issue relevant to the work of the
EMA that relates to this area.
Puma Biotechnology announced on August 22, 2016 that the MAA for
neratinib had been validated by the EMA. The MAA for neratinib is based
on results from both the Phase III ExteNET trial in extended adjuvant
early stage HER2-positive breast cancer and the Phase II CONTROL trial
in extended adjuvant early stage HER2-positive breast cancer. On August
2, 2017, Puma announced that the Committee for Medicinal Products for
Human Use (CHMP), the scientific committee of the EMA, had issued its
Day-180 List of Outstanding Issues in the process of their ongoing
regulatory review of Puma’s MAA. The Company expects to respond to the
Day-180 List of Outstanding Issues by the deadline of December 22, 2017.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the development and commercialization of innovative products to enhance
cancer care. The Company in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was
approved by the U.S. Food and Drug Administration in July 2017 for the
extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX® (neratinib) tablets. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.
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 only recently commenced commercialization and
shipment of its only FDA approved product; the Company’s dependence upon
the commercial success of NERLYNX (neratinib); the Company’s history of
operating losses and its expectation that it will continue to incur
losses for the foreseeable future; risks and uncertainties related to
the Company’s ability to achieve or sustain profitability; the Company’s
ability to predict its future prospects and forecast its financial
performance and growth; failure to obtain sufficient capital to fund the
Company’s operations; the effectiveness of sales and marketing efforts;
the Company’s ability to obtain FDA approval or other regulatory
approvals in the United States or elsewhere for other indications for
neratinib or other product candidates; 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; risks pertaining to securities class action, derivative and
defamation lawsuits; the Company’s dependence on licensed intellectual
property; and the other risk factors disclosed in the periodic and
current reports filed by the Company with the Securities and Exchange
Commission from time to time, including the Company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2017. 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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