CORRECTING and REPLACING Puma Biotechnology Initiates a Managed Access Program for PB272 (Neratinib) Outside the United States

Caligor Opco LLC to provide regulatory, logistical and supply chain

LOS ANGELES–(BUSINESS WIRE)–The second paragraph, last sentence of the release has changed.

The corrected release reads:


Caligor Opco LLC to provide regulatory, logistical and supply chain

Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has
initiated a Managed Access Program for PB272 (neratinib). Managed access
programs provide physicians and patients access to medicines when there
are limited or no other therapeutic options available.

Puma’s Managed Access Program for neratinib will enable participation
from countries outside the United States, including European Union
Member States, where permitted by applicable rules, procedures and
regulatory authorities. The program will provide access to neratinib for
the treatment of early stage HER2-positive breast cancer (extended
adjuvant setting), HER2-positive metastatic breast cancer and
HER2-mutated solid tumors. Patients must not be able to participate in
any ongoing neratinib clinical trial to qualify for Puma’s managed
access program. Patients in the managed access program will be given
neratinib and will be instructed to take a prophylaxis during treatment
to manage neratinib-related diarrhea, which the Company expects will
consist of high dose loperamide and budesonide.

Puma Biotechnology has partnered with Caligor Opco LLC, which
specializes in early access to medicines, to implement and oversee the
Managed Access Program for neratinib.

“The guiding principle behind our Managed Access Program is to provide
neratinib — through physician-requested access — to patients with
significant unmet medical needs as soon as practical, in a manner that
is safe, ethical, compliant and effective,” said Alan H. Auerbach, Chief
Executive Officer and President of Puma. “With Caligor managing the
day-to-day operations of the program, we can direct our efforts toward
our regulatory filings and implementing our plans for commercialization.”

Questions or inquiries regarding the Neratinib Managed Access Program
should be directed to

About Caligor

Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a
global company that manages the regulatory, logistics and supply chain
needs for global access programs as well as the sourcing, storing and
distribution of comparator drugs for clinical trials. Caligor’s global
access programs help to meet the medical needs of patients worldwide by
providing access to unlicensed / unapproved medicines in situations
where the drug has not yet been approved, or is otherwise commercially
unavailable. In addition, through its proprietary TrialAssist™ program,
Caligor optimizes its services by providing for labeling, QP
certification, storage, distribution and destruction of clinical trial
and unlicensed medicines managed in the access programs. The Company
serves pharmaceutical and biotechnology companies from facilities in
Secaucus, New Jersey, and Dartford, UK, as well as strategically
situated depot locations worldwide. More information is available at

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

Forward-Looking Statements:

This press release contains forward-looking statements, including
statements regarding the Managed Access Program for PB272 (neratinib)
for the treatment of early stage HER2-positive breast cancer (extended
adjuvant setting), HER2-positive metastatic breast cancer and
HER2-mutated solid tumors. 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.


Puma Biotechnology, Inc.
Alan H. Auerbach or Mariann Ohanesian,
David Schull or Darren Chia, +1-212-845-4271