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Puma Biotechnology Files New Drug Submission for NERLYNX® in Canada

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Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company,
announced that Health Canada has accepted for review the Company's New
Drug Submission (NDS) for the medicinal product NERLYNX® (neratinib) for
the extended adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer following adjuvant
trastuzumab-based therapy. The NDS recently passed the mandatory
validation period by Health Canada, the country's federal regulator for
drugs and health products, and has now entered the review period.

"Health Canada's acceptance of our NDS represents another important
regulatory milestone in our commitment to increasing access to NERLYNX
around the world to reduce disease recurrence following trastuzumab
therapy in patients with early stage HER2-positive breast cancer," said
Alan H. Auerbach, Chief Executive Officer and President of Puma. "We
look forward to working with Health Canada during their review of our
submission."

Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved
by the FDA in July 2017 for the extended adjuvant treatment of adult
patients with early stage HER2-positive breast cancer following adjuvant
trastuzumab-based therapy and is marketed in the United States as
NERLYNX®. The drug also received a recommendation for marketing
authorization from the Committee for Medicinal Products for Human Use
(CHMP) in June 2018 and is being reviewed by the European Commission,
which has the authority to approve medicines for the European Union.

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2
protein. HER2-positive breast cancer is often more aggressive than other
types of breast cancer, increasing the risk of disease progression and
death. Although research has shown that trastuzumab can reduce the risk
of early stage HER2-positive breast cancer returning after surgery, up
to 25% of patients treated with trastuzumab experience recurrence.

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. Puma 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.

Important Safety Information (ISI)
NERLYNX®
(neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with early-stage
HER2 overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Diarrhea: Aggressively manage diarrhea occurring despite
    recommended prophylaxis with additional antidiarrheals, fluids, and
    electrolytes as clinically indicated. Withhold NERLYNX in patients
    experiencing severe and/or persistent diarrhea. Permanently
    discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade
    ≥ 2 diarrhea that occurs after maximal dose reduction.
  • Hepatotoxicity: Monitor liver function tests monthly for the
    first 3 months of treatment, then every 3 months while on treatment
    and as clinically indicated. Withhold NERLYNX in patients experiencing
    Grade 3 liver abnormalities and permanently discontinue NERLYNX in
    patients experiencing Grade 4 liver abnormalities.
  • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
    patients of potential risk to a fetus and to use effective
    contraception.

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were
diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis,
decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased
and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology,
Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

DRUG INTERACTIONS:

  • Gastric acid reducing agents: Avoid concomitant use with proton pump
    inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
    hours after antacid dosing.
  • Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
  • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
    narrow therapeutic agents that are P-gp substrates when used
    concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

  • Lactation: Advise women not to breastfeed.

Please see Full
Prescribing Information
for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given
orally once daily with food, continuously for one year. Antidiarrheal
prophylaxis should be initiated with the first dose of NERLYNX and
continued during the first 2 months (56 days) of treatment and as needed
thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the
Puma Patient Lynx support program to assist patients and healthcare
providers with reimbursement support and referrals to resources that can
help with financial assistance. More information on the Puma Patient
Lynx program can be found at www.NERLYNX.com
or 1-855-816-5421.

Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.

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