Puma Biotechnology and CANbridge
Pharmaceuticals Terminate License Agreement in Greater
China
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical
company, and Pierre Fabre, a leading French pharmaceutical company,
have agreed to extend the terms of the 2019 license agreement which
grants Pierre Fabre exclusive rights to develop and commercialize
NERLYNX® (neratinib) within Europe, Turkey, Middle East and Africa.
The amended agreement extends Pierre Fabre’s commercial rights for
NERLYNX to Greater China, which includes mainland China, Taiwan,
Hong Kong and Macau.
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Under the terms of the amendment, Puma will receive an upfront
payment of $50 million, as well as additional regulatory and
sales-based milestone payments that could add up to an additional
$240 million. These milestones will be based solely on regulatory
and sales achievements in Greater China. In addition, Puma will
receive significant double-digit tiered royalties on the sales of
NERLYNX in Greater China.
Concomitantly, Puma and CANbridge Pharmaceuticals, Inc., a
biopharmaceutical company focused on developing drug candidates in
China and North Asia, have mutually agreed to terminate the license
agreement to commercialize NERLYNX (neratinib) in Greater China.
Puma has agreed to pay CANbridge a one-time termination fee of $20
million to return all rights to neratinib in Greater China back to
Puma. Additionally, Puma has agreed to dismiss the arbitration
demand it filed on July 28, 2020 against CANbridge related to the
parties’ 2018 license agreement, and as part of the settlement,
CANbridge has agreed to dismiss its counterclaims against Puma.
Such settlement is limited to claims that arose in arbitration, or
could have been raised in arbitration, as well as claims arising
under the to be terminated license agreement.
Alan H. Auerbach, Chief Executive Officer and President of Puma,
said, “We are pleased to extend our collaboration with Pierre Fabre
into the Greater China region. Pierre Fabre is well equipped with
existing infrastructure to make NERLYNX a success in mainland China
and Pierre Fabre plans to make NERLYNX available to breast cancer
patients in mainland China in the second quarter of this year.”
“We are excited about the opportunity to provide NERLYNX to
Chinese patients with early stage HER2-positive breast cancer,”
said Jean-Luc Lowinsky, Chief Executive Officer, Pierre Fabre
Pharmaceuticals. “Our oncology team based in Shanghai is fully
committed to start the commercialization of NERLYNX, which
perfectly complements our existing NAVELBINE chemotherapy in breast
and lung cancers.”
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 for
adult patients with advanced or metastatic HER2-positive breast
cancer in combination with capecitabine in patients who have
received two or more prior anti-HER2 based regimens and is marketed
in the United States as NERLYNX® (neratinib) tablets.
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 Pierre Fabre
Pierre Fabre is a French health and beauty care company with
35-years of experience in innovation, development, manufacturing
and commercialization in oncology. The company has recently
reaffirmed oncology as one of its main R&D and commercial
priorities, focusing on targeted therapies, biotherapies and
immuno-oncology. Its therapeutic areas cover high unmet medical
needs, including colorectal, breast, lung cancers, melanoma and
pre-cancerous conditions like actinic keratosis.
The Pierre Fabre group has been operating in China since 2008.
Based in Beijing, Guangzhou and Shanghai, Pierre Fabre
commercializes an anticancer drug, Navelbine, and three
dermo-cosmetic brands, namely market-leader Eau Thermale Avène,
Klorane and René Furterer. China is the group’s first subsidiary
after France.
In 2019, Pierre Fabre generated 2.4 billion euros in revenues,
of which two-thirds originated from its international business.
Pierre Fabre, which has always been headquartered in the South-West
of France, employs approximately 10,000 people worldwide, owns
subsidiaries and offices in 45 countries and enjoys distribution
agreements in over 130 countries. Pierre Fabre is 86%-owned by the
Pierre Fabre Foundation, a government-recognised public-interest
foundation, and secondarily by its own employees through an
international employee stock ownership plan.
In 2019, Ecocert Environment assessed the Group’s corporate
social and environmental responsibility approach according to the
ISO 26000 standard on sustainable development and awarded it the
ECOCERT 26000 “Excellence” level.
Further information about Pierre Fabre can be found at
www.pierre-fabre.com, @PierreFabre.
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.
IMPORTANT EU NERLYNX® (neratinib) SAFETY INFORMATION
All suspected adverse reactions should be reported in
accordance with the national reporting system.
The adverse reactions described in this section were identified
in the randomized Phase 3 clinical trial (n=2840; randomized 1:1 to
receive either NERLYNX or placebo). The most common adverse
reactions of any grade were diarrhea (93.6%), nausea (42.5%),
fatigue (27.3%), vomiting (26.8%), abdominal pain (22.7%), rash
(15.4%), decreased appetite (13.7%), abdominal pain upper (13.2%),
stomatitis (11.2%), and muscle spasms (10.0%).
The most common Grade 3-4 adverse reactions were diarrhea (Grade
3, 36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade
4, 0.1%).
Adverse reactions reported as serious included diarrhea (1.9%),
vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine
aminotransferase increased (0.4%), aspartate aminotransferase
increased (0.4%), abdominal pain (0.3%), fatigue (0.3%) and
decreased appetite (0.2%).
For full European prescribing information, please refer to
the NERLYNX (neratinib) Summary of Product Characteristics on the
European Medicines Agency website
(http://www.ema.europa.eu/ema/).
IMPORTANT SAFETY INFORMATION, U.S. INDICATIONS
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) 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.
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, once filed, Puma’s Annual Report on Form 10-K
for the year ended December 31, 2020. 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/20210225006150/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com
David Schull or Maggie Beller, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
Anne Kerveillant, Pierre Fabre +33 6 20 88 54 57
anne.kerveillant@pierre-fabre.com
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