LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
and Pint Pharma International S.A., a company focused on innovative
treatments for patients in Latin America with cancer, rare diseases, and
genetic disorders, have entered into an agreement for Pint Pharma to
commercialize NERLYNX® (neratinib) in Argentina, Brazil, Chile,
Colombia, Mexico and the rest of Latin America.
NERLYNX is not approved currently for commercialization outside of the
United States. Pint Pharma will be responsible for seeking the requisite
regulatory approvals and, once approved on a country by country basis,
for commercializing NERLYNX in Latin America. Puma will receive an
upfront payment as well as potential regulatory and commercial milestone
payments totaling up to $34.5 million. In addition, Puma will receive
significant double-digit royalties on NERLYNX sales in Latin America.
“Puma is committed to making NERLYNX commercially available to breast
cancer patients around the world,” stated Alan H. Auerbach, Chief
Executive Officer and President of Puma. “Our new partnership with Pint
Pharm in Latin America demonstrates our commitment to ensure NERLYNX
access to patients globally while we continue to focus our commercial
resources on the U.S. market. We are confident this new partnership will
help patients in Latin America access NERLYNX at the earliest
opportunity.”
“We are excited to be collaborating closely with Puma as we plan to file
for regulatory approvals of NERLYNX throughout Latin America,” said
David Muñoz Guzman, Chief Executive Officer of Pint. “NERLYNX is highly
complementary to our comprehensive oncology product offering and it will
be the first breast cancer treatment within our portfolio, strengthening
Pint Pharma’s presence in the Latin American oncology market.
Furthermore, we plan to accelerate patient access to NERLYNX via the
various early access programs available throughout the region.”
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 Pint Pharma
Pint Pharma is a private, Latin American focused pharmaceutical company,
devoted to the development, registration and commercialization of
specialty based treatments. Pint Pharma benefits from leaders with
extensive experience in the pharmaceutical sector and who are based
strategically throughout Latin America and Europe. Pint Pharma has a
long track record of developing strong relationships with global
pharmaceutical and healthcare companies. Pint Pharma strives to be the
first Pan-Latin American provider of innovative and high value-added
treatments within Oncology, Rare Diseases and Specialty Care.
Additional information can be found at www.pint-pharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the commercialization and availability of NERLYNX®
(neratinib) in Latin America; the registration and regulatory
approval of NERLYNX in the region; the expected milestone payments and
royalties payable under the agreement with Pint Pharma; 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 Company’s dependence
on the commercial success of NERLYNX; 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 regulatory approval of NERLYNX outside of
the United States; 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; 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 Annual Report on
Form 10-K for the year ended December 31, 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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