FDA Decision Expected by Early Q1 2015
BASKING RIDGE, N.J. -- (Business Wire)
Ipsen
N.A., an affiliate of Ipsen (Euronext:IPN; ADR:IPSEY) today
announced that the U.S. Food and Drug Administration (FDA) has accepted
and granted priority review of its supplemental New Drug Application
(sNDA) for Somatuline® Depot® 120mg injection in
the treatment of gastroenteropancreatic neuroendocrine tumors
(GEP-NETs). The FDA designates priority review status to drug candidates
that have the potential to offer a significant improvement in treatment
compared to currently approved options. A decision is expected in early
Q1, 2015.
The regulatory submission was supported by the results of the
investigational CLARINET® Phase III study, which demonstrated
the antitumor effect of Somatuline® in the treatment of
patients with GEP-NETs, and which was recently published in the July
17th issue of The New England Journal of Medicine2.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen
stated: “We are pleased that the US regulatory authorities have
accepted the filing for Somatuline® in the
treatment of GEP-NETs and that the dossier has been granted priority
review. We are excited about the potential benefits Somatuline®
could bring to patients suffering from this debilitating disease”.
Cynthia Schwalm, President and CEO of Ipsen North America said
“To date, somatostatin analogs are approved to manage symptoms of GEP
NETs and are not approved as anti-tumor therapy. Somatuline®
is the first and only somatostatin analog to demonstrate a statistically
significant improvement in progression free survival in GEP NET in a
large, multinational study clinical trial."
The data from CLARINET® is investigational, as Somatuline® Depot®
is not approved for the treatment of GEP-NETs. Somatuline® Depot®
is currently approved in the US for the treatment of acromegaly.
About gastroenteropancreatic neuroendocrine tumors
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are serious and
rare types of cancer. They constitute a heterogeneous group of tumors
most often arising from cells in the gastrointestinal tract and the
pancreas; although rare, their incidence has been on the rise (4-6 fold
increase in the last 30 years). They have the ability to secrete
functional amines and peptides and based on the type and amount of these
bioactive substances in circulation, they can or cannot result in an
identifiable hormonal clinical syndrome. GEP-NETs can be clinically
silent for long periods of time, delaying the diagnosis until late
presentation with hormonal related symptoms or with symptoms related to
tumor mass effect such as intestinal obstruction or abdominal pain.
About Somatuline® Depot in the United States
In the United States, Somatuline® Depot is indicated for the
long-term treatment of patients with acromegaly who have had an
inadequate response to or cannot be treated with surgery and/or
radiotherapy.
Somatuline® Depot is not indicated for the treatment of
GEP-NETs.
The active substance in Somatuline® Depot is lanreotide
acetate, a somatostatin analogue that inhibits the secretion of several
endocrine, exocrine and paracrine amines and peptides.
Select Important Safety Information about Somatuline®
Depot for Patients
Somatuline® Depot may cause serious side effects including:
• Gallstones
• Changes in your blood sugar (high blood sugar or low blood sugar)
• Slow heart rate
• High blood pressure
The most common side effects of Somatuline® Depot include
diarrhea, gallstones, stomach area (abdominal) pain, nausea, and pain,
itching, or a lump at the injection site.
These are not all the possible side effects of Somatuline®
Depot. Tell your doctor if you have any side effect that bothers you or
that does not go away.
Before you receive Somatuline® Depot, talk to your doctor
about:
All of your medical conditions, including:
-
Gallbladder, thyroid, heart, kidney, or liver problems
-
Diabetes
-
Allergy to latex or natural dry rubber
-
Pregnancy or plans to become pregnant
-
It is not known if Somatuline® Depot could harm your
unborn baby
-
Breast-feeding or plans to breast-feed
-
It is not known if Somatuline® Depot passes into breast
milk
Any medicines (prescription and nonprescription) you are taking,
including:
-
Insulin or other diabetes medicines
-
A cyclosporine (such as GengrafTM, Neoral®, or Sandimmune®)
-
A medicine called bromocriptine (such as Parlodel®)
-
Medicines that lower your heart rate (such as beta blockers)
While on Somatuline® Depot:
-
Tell your doctor if you have sudden pain in your upper right stomach
(abdominal) area or in your right shoulder or between your shoulder
blades, or if you have yellowing of your skin and whites of your eyes,
fever with chills, or nausea as these could be symptoms related to
gallstones.
-
If you have diabetes, test your blood sugar as your doctor tells you
to. Your doctor may change your dose of diabetes medicine especially
when you first start receiving Somatuline® Depot or if your
dose of Somatuline® Depot changes.
-
Before each treatment, read the Patient Information that comes with
each Somatuline® Depot package as there may be new
information. Talk with your doctor about your medical condition or
your treatment. Your doctor is your primary source of information
about treatment.
Please see the Patient Information for Somatuline® Depot at http://somatulinedepot.com/assets/files/fpo_patient_pi.pdf
Select Important Safety Information about Somatuline®
Depot for Healthcare Professionals
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 cardiac studies,
the most common cardiac adverse reactions were sinus bradycardia,
bradycardia, and hypertension. Dose adjustment of coadministered drugs
that decrease heart rate may be necessary.
-
Somatuline® may decrease bioavailability of cyclosporine.
Cyclosporine dose may need to be adjusted.
Adverse Reactions
The most common adverse reactions (incidence >5%) were diarrhea (37%),
cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site
reaction (9%), constipation (8%), flatulence (7%), headache (7%),
arthralgia (7%), vomiting (7%), and loose stools (6%).
Use in Special Populations
Patients with moderate and severe renal impairment or moderate and
severe hepatic impairment: Initial dose is 60 mg every 4 weeks.
Please see the full Prescribing Information for Somatuline®
Depot at http://somatulinedepot.com/pdf/pi_2013november.pdf
About CLARINET®
CLARINET® is an investigational, phase III, randomized,
double-blind, placebo-Controlled study 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® Autogel®
120 mg (n=101) or placebo (n=103). At enrollment, primary tumor
locations were pancreas (44%), 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 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 18.0
months and 33.0% had not progressed or died at 96 weeks, whereas the
median PFS for Somatuline® treated patients was not reached
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 based on a hazard ratio of 0.47 (95% CI:
0.30–0.73). These statistically and clinically significant
antiproliferative effects of Somatuline® 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%). Quality of life measures were not different
between the Somatuline® and placebo groups. Safety data
generated from the study are consistent with the known safety profile of
Somatuline®.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.2 billion in 2013. 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 €260 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
fulfil 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.
1 Gastroenteropancreatic neuroendocrine tumors
2 “Lanreotide in Metastatic Enteropancreatic Neuroendocrine
Tumors”, July 17th 2014 edition, N. Engl. J. Med. 2014; 371: 224-233
Contacts:
Media
Ipsen
Rob Kloppenburg, +1 908 275 6388
Vice
President, North America, Communications
robert.kloppenburg@ipsen.com
or
HealthStar
PR
Erinn White, 917-769-2785
ewhite@healthstarpr.com
or
Ipsen
Didier
Véron, +33 (0)1 58 33 51 16, (fax) +33 (0)1 58 33 50 58
Senior
Vice-Président, Public Affairs and Communication
didier.veron@ipsen.com
or
Brigitte
Le Guennec, +33 (0)1 58 33 51 17, (fax) +33 (0)1 58 33 50 58
Media
and Public Relations Manager
brigitte.le.guennec@ipsen.com
or
Financial
Community
Stéphane Durant des Aulnois, +33 (0)1 58 33 60
09, (fax) +33 (0)1 58 33 50 63
Investor Relations Director
stephane.durant.des.aulnois@ipsen.com
or
Thomas
Peny-Coblentz, +33 (0)1 58 33 56 36, (fax) +33 (0)1 58 33 50 63
Investor
Relations Deputy Director
thomas.peny-coblentz@ipsen.com
Source: Ipsen
© 2024 Canjex Publishing Ltd. All rights reserved.