LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
and Specialised Therapeutics Asia, an international biopharmaceutical
company with strategic focus and expertise in Australia, New Zealand and
South East Asia, have entered into an exclusive agreement under which
Specialised Therapeutics will commercialize NERLYNX® (neratinib)
throughout South East Asia, beginning with Australia, Singapore,
Malaysia, Brunei and New Zealand. Currently, Specialised Therapeutics
markets Abraxane® and other oncology products in these countries.
NERLYNX is not approved currently for commercialization outside of the
United States. Specialised Therapeutics will be responsible for seeking
the requisite regulatory approvals and, once approved, for
commercializing NERLYNX in those countries. Puma will receive upfront
and milestone payments of up to $4.5 million throughout the term of this
agreement, as well as significant double digit royalties on NERLYNX
sales in all regions in which Specialised Therapeutics commercializes
NERLYNX.
“Our new agreement with Specialised Therapeutics demonstrates our
commitment to bringing NERLYNX to patients around the world while
continuing to focus our commercial resources on the U.S. market,” stated
Alan H. Auerbach, Chief Executive Officer and President of Puma. “We are
confident this new partnership will help patients in our new partner’s
regions access NERLYNX at the earliest opportunity.”
“We are thrilled to be selected as Puma’s first international partner
able to provide this therapy to women in our region. We plan to expedite
access to this important therapy with a Special Access Program, which we
expect to open in Australia in the first quarter of 2018. In tandem, we
plan to file for Therapeutic Goods Administration (TGA) registration and
to seek regulatory approval to market in other countries, including
Singapore, Malaysia, Brunei and New Zealand,” said Carlo Montagner,
Chief Executive Officer of Specialised Therapeutics. “We expect to have
regulatory approval for NERLYNX in Australia by the second quarter of
2019.”
Neratinib was approved by the U.S. Food and Drug Administration (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® (neratinib) tablets.
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.
IMPORTANT SAFETY INFORMATION
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.
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. NERLYNX®
(neratinib) is approved for commercial use by prescription in the United
States as extended adjuvant therapy for early stage HER2-positive breast
cancer following adjuvant trastuzumab-based therapy and is marketed as
NERLYNX. 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 commercialization of NERLYNX and the continued
development of its other advanced drug candidates directed at the
treatment of HER2-positive breast cancer. The Company believes that
NERLYNX has clinical application in the potential treatment of several
other cancers that over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
About Specialised Therapeutics Asia
Specialised Therapeutics Asia Pte Ltd (ST Asia) is an international
biopharmaceutical company established to provide pioneering healthcare
solutions to patients throughout South East Asia, including Australia
and New Zealand.
ST Asia and its regional affiliates collaborate with leading global
pharmaceutical and diagnostic companies to bring novel, innovative and
life changing healthcare solutions to patients affected by a range of
diseases. ST Asia is committed to making new and novel therapies
available to patients around the world, targeting diseases where there
remains an unmet medical need. ST Asia’s broad therapeutic portfolio
currently includes novel agents in oncology, haematology, neurology,
ophthalmology and supportive care.
Additional information can be found at www.stabiopharma.com
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the commercialization and commercial availability
of NERLYNX® in South East Asia, including in Australia,
Singapore, Malaysia, Brunei and New Zealand; the registration of, and
regulatory approval of, NERLYNX in the region and these countries; the
expected milestone payments and royalties payable under the agreement
with Specialised Therapeutics; the benefits of NERLYNX and neratinib;
the Company’s clinical trials; and the announcement of data relative to
those trials. 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 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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