FDA Decision Expected by Early Q1
2015
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.
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1 Gastroenteropancreatic neuroendocrine tumors
2 “Lanreotide in Metastatic Enteropancreatic Neuroendocrine
Tumors”, July 17th 2014 edition, N. Engl. J. Med. 2014; 371:
224-233
MediaIpsenRob Kloppenburg, +1 908 275 6388Vice
President, North America,
Communicationsrobert.kloppenburg@ipsen.comorHealthStar PRErinn
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Véron, +33 (0)1 58 33 51 16, (fax) +33 (0)1 58 33 50 58Senior
Vice-Président, Public Affairs and
Communicationdidier.veron@ipsen.comorBrigitte Le Guennec,
+33 (0)1 58 33 51 17, (fax) +33 (0)1 58 33 50 58Media and Public
Relations Managerbrigitte.le.guennec@ipsen.comorFinancial
CommunityStéphane Durant des Aulnois, +33 (0)1 58 33 60
09, (fax) +33 (0)1 58 33 50 63Investor Relations
Directorstephane.durant.des.aulnois@ipsen.comorThomas
Peny-Coblentz, +33 (0)1 58 33 56 36, (fax) +33 (0)1 58 33 50
63Investor Relations Deputy
Directorthomas.peny-coblentz@ipsen.com