Last name of Chief Executive Officer of Pierre Fabre
Pharmaceuticals in fourth paragraph should read: Lowinski (instead
of Lowinsky).
The corrected release reads:
PUMA BIOTECHNOLOGY AMENDS LICENSE AGREEMENT
WITH PIERRE FABRE TO INCLUDE ADDITIONAL COUNTRIES
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, and Pierre Fabre have agreed to extend the terms of the
license agreement in which Puma granted Pierre Fabre exclusive
rights to develop and commercialize NERLYNX® (neratinib) within
Europe and part of Africa. The amended agreement extends Pierre
Fabre’s commercial rights for NERLYNX to the Middle East, South
Africa, Sudan and Turkey.
Under the terms of the agreement, Puma will receive an upfront
payment of $4 million, as well as additional regulatory and
sales-based milestone payments totaling up to $3 million. Net sales
of NERLYNX from the countries in this extension territory will be
included in the calculation of payments related to sales milestones
and royalties from the original license agreement signed earlier
this year.
“The expansion of our license agreement with Pierre Fabre is
indicative of our belief in their robust commercial infrastructure
across these additional territories,” said Alan H. Auerbach, Chief
Executive Officer and President of Puma. “Puma remains committed to
providing access to NERLYNX to patients around the world. By
expanding Pierre Fabre’s commercial territory, we believe HER-2
positive breast cancer patients in these territories will have
access to this much-needed therapy.”
“We are pleased to confirm this expanded partnership with Puma
Biotechnology,” stated Jean-Luc Lowinski, Chief Executive Officer,
Pierre Fabre Pharmaceuticals. “It will bring NERLYNX to patients
seeking adjuvant treatment options for breast cancer in these new
countries where Pierre Fabre is committed to making a difference in
the long term.”
About HER2-Positive Breast Cancer
Approximately 20 to 25 percent 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.
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 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 was granted
marketing authorization by the European Commission in August 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 Pierre Fabre
With a portfolio representing a continuum of activities spanning
from prescription drugs and consumer healthcare products to
dermo-cosmetics, Pierre Fabre is the second largest dermo-cosmetics
laboratory in the world, the second largest private French
pharmaceutical group and the market leader in France for products
sold over the counter in pharmacies. Its portfolio includes several
global brands and franchises, such as Eau Thermale Avène, Klorane,
Ducray, René Furterer, A-Derma, Galénic, Elancyl, Naturactive,
Pierre Fabre Health Care, Pierre Fabre Oral Care, Pierre Fabre
Dermatologie and Pierre Fabre Oncologie.
In 2018, Pierre Fabre generated 2.3 billion euros in revenues,
of which 64% came from its international business and 61% from its
dermo-cosmetics division. Pierre Fabre, which has always been
headquartered in the South-West of France, counts about 11,000
employees worldwide, owns subsidiaries and offices in 45 countries
and enjoys distribution agreements in over 130 countries. In 2018,
Pierre Fabre dedicated 187 million euros to R&D efforts, split
between oncology, consumer healthcare, dermatology and
dermo-cosmetics.
Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a
government-recognized 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.
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). The most common
adverse reactions of any grade were diarrhoea (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 diarrhoea
(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 diarrhoea (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 Regarding NERLYNX® (neratinib)
U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated for the extended adjuvant treatment of adult patients
with 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, 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. 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 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.
Forward-Looking Statements
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 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 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, 2018. 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/20191202005211/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
Valérie Roucoules, Pierre Fabre +33 6 20 88 61 65
valerie.roucoules@pierre-fabre.com
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