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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version on businesswire.com: https://www.businesswire.com/news/home/20180403005356/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1
424-248-6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Amiad Finkelthal,
+1-212-845-4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.comorPint
Pharma International S.A.David R Munoz or Alejandra
Pedrazaoffice@pint-pharma.chAlejandra.pedraza@pint-pharma.com
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