LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
and CANbridge Life Sciences, a biopharmaceutical company focused on
developing Western drug candidates in China and North Asia, have entered
into an exclusive agreement under which CANbridge will develop and
commercialize NERLYNX® (neratinib) in mainland China, Taiwan, Hong Kong,
and Macau (greater China).
NERLYNX is not approved currently for commercialization outside of the
United States. CANbridge will be responsible for seeking the requisite
regulatory approval and, once approved, for commercializing NERLYNX in
greater China. Puma will receive an upfront payment of $30 million and
potential milestone payments totaling up to $40 million upon achievement
of certain regulatory milestones. In addition, Puma will receive
significant double-digit royalties on NERLYNX sales in greater China and
potential milestone payments upon the achievement of certain sales-based
milestones.
“Puma is committed to providing access to NERLYNX to patients around the
world, and greater China represents a very large market opportunity,”
stated Alan H. Auerbach, Chief Executive Officer and President of Puma.
“While we continue to focus our commercial resources on the U.S. market,
we believe this new partnership with CANbridge will help patients in
greater China to access NERLYNX at the earliest opportunity.”
“We are excited about the opportunity to provide this therapy to
patients with HER2-positive cancer in our region,” said James Xue,
Ph.D., Chief Executive Officer and President of CANbridge Life Sciences.
“We plan to engage our local regulatory authorities in greater China to
expedite commercial access to NERLYNX, which we expect to provide in
parts of greater China by mid-2019. We are honored to have been selected
by Puma to develop and commercialize this important therapy, which we
believe has significant commercial potential in greater China in
HER2-positive cancers, including gastric cancer, where CANbridge will be
leading the clinical development in greater China.”
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. Neratinib (oral) was
approved by the FDA 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.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
About CANbridge Life Sciences
CANbridge Life Sciences, Ltd. is a clinical-staged bio-pharmaceutical
company accelerating development and commercialization of specialty
healthcare products for serious and critical medical conditions in China
and North Asia (Korea and Taiwan). CANbridge develops partnerships with
Western bio-pharmaceutical companies with clinical-stage pharmaceutical,
medical device or diagnostic products that are either unavailable in
China/North Asia or address medical needs that are underserved in the
region. CANbridge also licenses, or obtains exclusive rights to
commercialize, drug and device products that are approved in their home
markets for commercialization in China and North Asia. Led and backed by
a highly-seasoned executive team, with extensive Chinese drug
development experience, CANbridge has the capability to select, acquire,
develop and commercialize future therapeutics and diagnostics targeting
the unmet medical needs of Chinese and East Asian patients with serious
or critical conditions. CANbridge is privately-held and headquartered in
Beijing, China.
Additional information can be found at http://www.canbridgepharma.com/.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the commercialization and commercial availability
of NERLYNX® in greater China; the registration of, and
regulatory approval of, NERLYNX in the region; the expected milestone
payments and royalties payable under the agreement with CANbridge; the
benefits of NERLYNX and neratinib, including for the treatment of
gastric cancer; 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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