LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced that based on its recent meeting with the European Medicines
Agency (EMA), the Company plans to submit a Marketing Authorisation
Application (MAA) for the approval of neratinib for the extended
adjuvant treatment of HER2-positive early stage breast cancer in
patients who have previously been treated with a trastuzumab-containing
regimen in the first half of 2016.
Puma recently conducted an MAA pre-submission meeting with the EMA. The
purpose of this meeting was to provide the EMA with data from
neratinib’s non-clinical and clinical development programs that will
form the basis of MAA sections for EMA review and approval. The data
discussed with the EMA included non-clinical data (pharmacology,
toxicology and carcinogenicity) and clinical trial data including the
data from the Phase III trial of neratinib in the extended adjuvant
treatment of HER2-positive early stage breast cancer (ExteNET trial).
Upon review of this material, the EMA assessed that there were no
critical concerns that would prevent Puma from submitting a complete MAA
for European centralized review in support of neratinib for the extended
adjuvant treatment of HER2-positive early stage breast cancer in
patients who have previously been treated with a trastuzumab-containing
regimen.
Conference Call and Webcast
The Company will host a conference call to discuss this EMA meeting at
2:00 p.m. PST (5:00 p.m. EST) on Monday, November 30, 2015. 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 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 biopharmaceutical company with a focus on
the acquisition, development and commercialization of innovative
products to enhance cancer care. The Company aims to acquire proprietary
rights to these products, by license or otherwise, fund their research
and development and bring the products to market. 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, but
not limited to, statements regarding the development of our drug
candidates and the timing of regulatory filings. 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, 2014 and any subsequently filed Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K. 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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