Puma Biotechnology & Bixink Therapeutics Enter into Exclusive Licensing Agreement to Commercialize NERLYNX® (neratinib) in S...
April 30 2020 - 4:15PM
Business Wire
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, and Bixink Therapeutics, a new South Korean company
working in the field of anti-cancer drugs and digital therapeutics,
have entered into an exclusive agreement under which Bixink will
commercialize NERLYNX® (neratinib) in South Korea.
Bixink will be responsible for seeking the requisite regulatory
approval and, once approved, for commercializing NERLYNX in South
Korea. Under the terms of the agreement, Puma will receive upfront
and milestone payments of up to $6 million, as well as significant
double-digit royalties on the sales of NERLYNX in South Korea.
“Our new agreement with Bixink 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
excited about the potential to provide South Korean breast cancer
patients with access to NERLYNX.”
“We are excited about the opportunity to provide NERLYNX to
patients with HER2-positive breast cancer in South Korea and plan
to file for its market authorization before the end of 2020,” said
Dr. Sung Chul Kim, Chief Executive Officer of Bixink Therapeutics.
“NERLYNX is our top priority as we aspire to be a leading South
Korean company in the field of oncology therapeutics.”
Neratinib is approved in the United States for both the extended
adjuvant treatment of adult patients with early stage HER2-positive
breast cancer following adjuvant trastuzumab-based therapy and
HER2-positive metastatic breast cancer 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:
- As a single agent, for the extended adjuvant treatment of adult
patients with early-stage HER2-positive breast cancer, to follow
adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer,
who have received two or more prior anti-HER2 based regimens in the
metastatic setting.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea. If diarrhea
occurs despite recommended prophylaxis, treat 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 (reported in ≥ 5% of patients)
were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis, decreased appetite, muscle
spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased, and urinary
tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea,
vomiting, decreased appetite, constipation, fatigue/asthenia,
weight decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms.
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. When patients require gastric acid reducing
agents, use an H2-receptor antagonist or antacid. Separate NERLYNX
by at least 3 hours with antacids. Separate NERLYNX by at least 2
hours before or 10 hours after H2-receptor antagonists.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- Moderate CYP3A4 and P-glycoprotein (P-gp) dual 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.
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. Puma in-licenses the global
development and commercialization rights to PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral
was approved by the U.S. Food and Drug Administration in 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. In February 2020, NERLYNX was also
approved by the FDA in combination with capecitabine for the
treatment of adult patients with advanced or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting. NERLYNX was
granted marketing authorization by the European Commission in 2018
for the extended adjuvant treatment of adult patients with early
stage hormone receptor-positive HER2-overexpressed/amplified breast
cancer and who are less than one year from completion of prior
adjuvant trastuzumab-based therapy. NERLYNX is a registered
trademark of Puma Biotechnology, Inc.
Further information about Puma Biotechnology can be found at
www.pumabiotechnology.com.
About Bixink
Bixink Therapeutics Co. Ltd. is a new South Korean company
dedicated towards establishing a new treatment paradigm via
converging biotechnology and information technology. Currently
focused on the field of anti-cancer drugs and digital therapeutics,
Bixink will start commercialization of anti-cancer drug NERLYNX®
and aims to diligently secure follow up pipeline products,
including cancer supportive care and oncologics with novel drug
delivery. Bixink also actively seeks various opportunities for
collaboration such as co-development and strategic investment to
drive its momentum for growth. As one of the pioneers in the field
of digital therapeutics in South Korea, Bixink is capable of
analysis, R&D, development and validation, and plans to file an
Investigational Device Exemption (IDE) with the U.S. Food and Drug
Administration by the end of this year to launch its first
digitalized cognitive behavioral therapy for obsessive compulsive
disorder. In the long term, Bixink strives to create a new path by
encompassing medicines and digital therapeutics with better
clinical outcomes and cost-effectiveness for patients. Bixink
strives to push the boundaries of technology to transform
medicine.
To find out more about Bixink Therapeutics, please visit
www.bixink-therapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the international expansion of
NERLYNX. All forward-looking statements involve risks and
uncertainties that could cause Puma’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,
any adverse impact on Puma’s business or the global economy and
financial markets, generally, from the global COVID-19 pandemic,
and the risk factors disclosed in the periodic and current reports
filed by Puma with the Securities and Exchange Commission from time
to time, including Puma’s Annual Report on Form 10-K for the year
ended December 31, 2019 and subsequent reports. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Puma 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/20200430005669/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
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