NDA Filing Currently Anticipated Mid-2016
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company,
announced that based on its recent meetings with the U.S. Food and Drug
Administration (FDA), the Company now plans to submit its New Drug
Application (NDA) for the approval of neratinib for the treatment of
extended adjuvant breast cancer that has previously been treated with a
trastuzumab-containing regimen in mid-2016.
Puma has recently conducted a series of meetings and communications with
the FDA. The purpose of these communications was to provide the FDA with
the data from neratinib’s non-clinical and clinical development programs
that will form the basis of the Company’s NDA for neratinib for the
treatment of extended adjuvant breast cancer that has previously been
treated with a trastuzumab-containing regimen. The data discussed with
the FDA included preclinical data (pharmacology, toxicology,
reproductive toxicity, 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) and the Phase II trial of neratinib monotherapy in the extended
adjuvant treatment of HER2-positive early stage breast cancer where
patients received loperamide prophylaxis in order to prevent the
neratinib-related diarrhea. Following its review of this material, the
FDA requested that Puma amend the current statistical analysis plan for
the ExteNET trial to incorporate the FDA’s recommendations with regard
to rules for censoring the data for recurrent disease events or death.
For the primary endpoint of the ExteNET trial (Invasive Disease Free
Survival), the analysis was based on all recurrent disease events and
deaths occurring within 2 years and 28 days post randomization. The FDA
has requested that events (disease recurrence or deaths) observed after
missing 2 or more scheduled disease assessments be censored at the last
available disease assessment time prior to the event occurrence. The
FDA’s requested approach was a sensitivity analysis used in the ExteNET
trial’s original statistical analysis plan but will now be the primary
analysis approach used in the trial’s updated statistical analysis plan.
In order to accommodate this change, Puma expects to delay filing its
NDA for neratinib for the treatment of extended adjuvant breast cancer
that has previously been treated with a trastuzumab-containing regimen
until mid-2016.
The primary analysis results of the trial do not appear to be altered
materially by the updated analysis approach. Provided below are the
results of the original and updated analyses of the primary endpoint of
invasive disease-free survival (iDFS) for the intent to treat (ITT)
population:
1) ITT population applying the original event and censoring rule:
-
179 iDFS events
-
33% reduction in risk of iDFS vs. placebo (hazard ratio=0.67 (0.50,
0.91), 1-sided P=0.005)
-
iDFS rates 93.9% (neratinib arm) vs. 91.6% (placebo arm)
2) ITT population applying the revised event and censoring rule per FDA:
-
173 iDFS events
-
34% reduction in risk of iDFS vs. placebo (hazard ratio=0.66 (0.49,
0.90), 1-sided P=0.004)
-
iDFS rates 94.2% (neratinib arm) vs. 91.9% (placebo arm)
Conference Call and Webcast
The Company will host a conference call and webcast to discuss this
update at 1:30 p.m. PDT (4:30 p.m. EDT) on Monday, March 28, 2016. 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 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 is a
potent irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1, HER2
and HER4. Currently, the Company is primarily focused on the development
of the oral version of neratinib, and its most advanced drug candidates
are directed at the treatment of HER2-positive breast cancer. The
Company believes that neratinib has clinical application in the
treatment of several other cancers as well, including non-small cell
lung cancer and other tumor types that over-express or have a mutation
in HER2.
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 anticipated timing for the
filing of a new drug application. 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 and current 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, 2015. 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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