2020 News Releases
Puma Biotechnology Licensing Partner Specialised Therapeutics Receives Marketing Approval in Malaysia for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
LOS ANGELES, Calif., July 16, 2020 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a
biopharmaceutical company, announced that its licensing partner Specialised Therapeutics Asia (STA)
has received marketing approval of NERLYNX® (neratinib) in Malaysia from the Drug Control Agency
(DCA), under Malaysia's Ministry of Health (MOH). NERLYNX is indicated 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
STA Chief Executive Officer Carlo Montagner said, "This approval in Malaysia represents the fifth STA
approval of NERLYNX for commercialization, after approvals in Australia, New Zealand, Singapore and
Brunei. These approvals, along with pending regulatory submissions in the Philippines and other Southeast
Asian regions, will extend the reach of this medicine to patients who were previously underserved."
Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The commercial strategy
implemented by Specialized Therapeutics in Australia and the successful market entry into additional
countries throughout Southeast Asia support our commitment to expanding access to NERLYNX to
breast cancer patients around the world. Addressing recurrence in HER2-positive breast cancer patients
remains paramount for Puma and our global partners."
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease)
and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor
positive. 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 recurring, up to 25% of patients treated with
trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.
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 may be found atÂ www.pumabiotechnology.com.
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
WARNINGS AND PRECAUTIONS:
The most common adverse reactions (reported in ≥5% of patients) were as follows:
- 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
- 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.
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.
- 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
USE IN SPECIFIC POPULATIONS:
- 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.
Please see Full Prescribing Information for additional safety information.
- Lactation: Advise women not to breastfeed.
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.
This press release contains forward-looking statements, including statements regarding the worldwide
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, Puma's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2020, 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.
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
David Schull or Maggie Beller, Russo Partners, +1 212 845 4200
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