Ipsen
Biopharmaceuticals, Inc., an affiliate of Ipsen (Euronext: IPN; ADR:
IPSEY), today announced that Somatuline® Depot®
(lanreotide) Injection 120 mg (referred to as Somatuline®)
was approved by the U.S. Food and Drug Administration (FDA) for the
treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in
adult patients with unresectable, well or moderately differentiated,
locally advanced or metastatic disease to improve progression-free
survival (PFS).
“The approval of Somatuline® for the treatment of patients
living with gastrointestinal and pancreatic tumors is a major
achievement for Ipsen that will provide a new therapeutic option with
the potential to help many of the thousands of patients in the United
States suffering from this devastating disease,” said Cynthia
Schwalm, President and CEO of Ipsen Biopharmaceuticals, Inc.
“Somatuline® is the first and only treatment with a
statistically significant progression-free survival benefit approved by
the FDA for patients as an antitumor therapy in the treatment of
gastrointestinal and pancreatic neuroendocrine tumors. This is a
significant step forward in our mission to develop and deliver
innovative therapies to treat serious illnesses.”
The approval of Somatuline® was based on a 96-week landmark
registrational Phase III, double-blind, placebo-controlled study
(CLARINET®) of 204 patients enrolled in 48 centers
across 14 countries. The trial showed that Somatuline®
reduced the risk of disease progression or death by 53% versus placebo
in patients with advanced gastrointestinal and pancreatic neuroendocrine
tumors (p<0.001). Safety data generated from the Phase III study were
consistent with the known safety profile of Somatuline®. The
rates of discontinuation due to treatment-emergent adverse reactions
were 5% (5/101 patients) in the Somatuline® arm and 3% (3/103
patients) in the placebo arm.
Gastrointestinal and pancreatic neuroendocrine tumors are rare, but
serious cancers. There are an estimated 112,000 individuals currently
living with neuroendocrine tumors in the U.S., and the incidence and
prevalence of this type of cancer have risen 4-to-6 fold in the last 30
years. Furthermore, up to ninety percent of patients are incorrectly
diagnosed, many for more than 5 years, meaning that they are often
diagnosed at a late stage. During this process, patients may be
misdiagnosed with other gastrointestinal diseases, such as irritable
bowel syndrome or Crohn’s disease.
“Somatuline® is the first somatostatin analog to demonstrate
a statistically significant improvement in progression-free survival, a
clinically significant endpoint in oncology which measures how long the
patient continues to live with the disease without it getting any
worse,” said Dr. Alexandria Phan, Director of GI Medical Oncology at
Houston Methodist. “Somatuline® offers a new weapon in
our fight against this deadly disease.”
Maryann Wahmann, President of the Neuroendocrine Cancer Awareness
Network and a Carcinoid Cancer Patient added, “As a patient who also
started an advocacy group for this community, I know first-hand how
important it is to have a new treatment option with anticancer benefits
for neuroendocrine tumors.”
Somatuline® will be delivered via a newly approved,
ready-to-use, prefilled syringe which incorporates Safe’n’Sound®
technology, including a retractable needle guard to help avoid needle
sticks, and it is manufactured without latex or natural dry rubber. The
new delivery device does not require reconstitution and is a low volume
(0.5 mL) deep subcutaneous injection offering a streamlined process that
supports full dose delivery.
About Gastrointestinal and Pancreatic Neuroendocrine Tumors
Gastrointestinal and pancreatic neuroendocrine tumors, also known as
gastroenteropancreatic neuroendocrine tumors, are a rare type of cancer.
It is diagnosed in approximately 5 out of every 100,000 people in the
U.S. The average time until a GEP-NET patient is accurately diagnosed is
at least 5 years; with more than 80% of patients seeing at least three
doctors prior to their diagnosis. Because of this, most patients are
diagnosed while in the advanced stages of the disease, which often leads
to a poor prognosis. Additionally, the symptoms of GEP-NETs are
gastrointestinal in nature, thus they can be misdiagnosed as Crohn’s
disease or irritable bowel syndrome (IBS).
About the Phase III Study
The approval of Somatuline® Depot® in
gastrointestinal and pancreatic neuroendocrine tumors is based on a
Phase III, randomized, double-blind, placebo-controlled study (CLARINET®)
of lanreotide's antiproliferative response in patients with
enteropancreatic neuroendocrine tumors (ClinicalTrials.gov NCT00353496).
This 96-week multinational study was conducted in collaboration with the
UK & Ireland Neuroendocrine Tumour Society (UKI NETS) and the European
Neuroendocrine Tumour Society (ENETS).
A total of 204 patients from 48 centers across 14 countries with well or
moderately differentiated non-functioning enteropancreatic
neuroendocrine tumors and a proliferation index (Ki67) of <10%, were
randomized to treatment with Somatuline®Depot® 120
mg (n=101) or placebo (n=103). At enrollment, primary tumor locations
were pancreas (45%), midgut (36%), hindgut (7%) and unknown (13%). Most
patients had stable disease (96%) and were treatment-naïve (84%). Thirty
percent of patients had a Ki67 of 3% to <=10% (WHO grade 2) and 33% had
an hepatic tumor load >25%.
The primary efficacy endpoint was progression-free survivial (defined as
time to either disease progression (centrally assessed using Response
Evaluation Criteria In Solid Tumors, RECIST 1.0) or death). Two baseline
computed tomography or magnetic resonance imaging scans (12 to 24 weeks)
were performed, followed by additional scans at 12- week intervals
during the first year and 24-week intervals during the second year up to
96 weeks.
The data showed that placebo-treated patients had a median PFS of 16.6
months and 33.0% had not progressed or died at 96 weeks, whereas the
median PFS for Somatuline® treated patients was not reached
and will be greater than 22 months and 65.1% had not progressed or died
at 96 weeks (stratified logrank test, p<0.001). This represented a 53%
reduction in risk of disease progression or death with Somatuline®
Depot compared to placebo, based on a hazard ratio of 0.47 (95% CI:
0.30-0.73). These statistically and clinically significant
antiproliferative effects of Somatuline® Depot®
were observed in a large population of patients with grade G1 or G2
(World Health Organization classification) GEP-NETs, and independent of
hepatic tumor volume (<=25% or >25%). Overall survival and quality of
life measures were not different between Somatuline® and
placebo groups. Safety data generated from the study are consistent with
the known safety profile of Somatuline®.
Indication:
Somatuline® Depot® (lanreotide) Injection 120 mg
is indicated for the treatment of adult patients with unresectable,
well- or moderately differentiated, locally advanced or metastatic
gastroenteropancreatic neuroendocrine tumors to improve progression-free
survival.
Important Safety Information
Contraindications:
Somatuline® is contraindicated in patients with
hypersensitivity to lanreotide or related peptides.
Warnings and Precautions:
-
Somatuline may reduce gallbladder motility and lead to gallstone
formation. Periodic monitoring may be needed.
-
Patients may experience hypoglycemia or hyperglycemia. Glucose level
monitoring is recommended and antidiabetic treatment adjusted
accordingly.
-
Somatuline may decrease heart rate. In patients treated for GEP-NETs,
the incidence of heart rate < 60 bpm was 23% with Somatuline vs 16%
with placebo. Incidence of heart rate < 50 bpm or bradycardia was 1%
in each group.
-
Somatuline may decrease bioavailability of cyclosporine. Cyclosporine
dose may need to be adjusted.
Adverse Reactions:
In the GEP-NET pivotal trial, the most common adverse reactions
(incidence >10% and more common than placebo) in patients treated with
Somatuline® Depot® vs placebo were abdominal pain
(34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%),
headache (16% vs 11%), injection site reaction (15% vs 7%),
hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis
(14% vs 7%).
You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or
to Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.
Please see the full Prescribing Information for Somatuline®
Depot® by accessing the following link.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding EUR1.2 billion in 2013. One of the leading affiliates is
Ipsen Biopharmaceuticals, Inc., the North American arm of Ipsen,
headquartered in Basking Ridge, NJ. Ipsen's ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by 3 franchises:
neurology, endocrinology and uro-oncology. Moreover, the Group has an
active policy of partnerships. Ipsen's R&D is focused on its innovative
and differentiated technological platforms, peptides and toxins. In
2013, R&D expenditure totaled close to EUR260 million, representing more
than 21% of Group sales. Moreover, Ipsen also has a significant presence
in primary care. The Group has close to 4,600 employees worldwide.
Ipsen's shares are traded on segment A of Euronext Paris (stock code:
IPN, ISIN code: FR0010259150) and eligible to the "Service de Règlement
Différé" ("SRD"). The Group is part of the SBF 120 index. Ipsen has
implemented a Sponsored Level I American Depositary Receipt (ADR)
program, which trade on the over-the-counter market in the United States
under the symbol IPSEY. For more information, visit www.ipsen.com.
Forward Looking Statements
The forward-looking statements, objectives and targets contained herein
are based on the Group's management strategy, current views and
assumptions. Such statements involve known and unknown risks and
uncertainties that may cause actual results, performance or events to
differ materially from those anticipated herein. All of the above risks
could affect the Group's future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today. Use of the words "believes,"
"anticipates" and "expects" and similar expressions are intended to
identify forward-looking statements, including the Group's expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and
potential future acquisitions, which may alter these parameters. These
objectives are based on data and assumptions regarded as reasonable by
the Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual results
may depart significantly from these targets given the occurrence of
certain risks and uncertainties, notably the fact that a promising
product in early development phase or clinical trial may end up never
being launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might face
competition from generic products that might translate into a loss of
market share. Furthermore, the Research and Development process involves
several stages each of which involves the substantial risk that the
Group may fail to achieve its objectives and be forced to abandon its
efforts with regards to a product in which it has invested significant
sums. Therefore, the Group cannot be certain that favourable results
obtained during pre-clinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will be
sufficient to demonstrate the safe and effective nature of the product
concerned. There can be no guarantees a product will receive the
necessary regulatory approvals or that the product will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks and
uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation; global
trends toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approval; the
Group's ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the Group's patents and other protections for
innovative products; and the exposure to litigation, including patent
litigation, and/or regulatory actions. The Group also depends on third
parties to develop and market some of its products which could
potentially generate substantial royalties; these partners could behave
in such ways which could cause damage to the Group's activities and
financial results. The Group cannot be certain that its partners will
fulfill their obligations. It might be unable to obtain any benefit from
those agreements. A default by any of the Group's partners could
generate lower revenues than expected. Such situations could have a
negative impact on the Group's business, financial position or
performance. The Group expressly disclaims any obligation or undertaking
to update or revise any forward looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements
are based, unless so required by applicable law. The Group's business is
subject to the risk factors outlined in its registration documents filed
with the French Autorité des Marchés Financiers.
SOMATULINE DEPOT is a registered trademark of IPSEN PHARMA
S.A.S.
Safe’n’Sound is a registered trademark of NEMERA LA
VERPILLIERE SAS.
Copyright Business Wire 2014