Regulatory authorities decisions expected in early Q1, 2015 in US and
in Q2, 2015 in Europe
Company Website:
http://www.ipsen.com
PARIS -- (Business Wire)
Regulatory News:
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. Decision is expected in early Q1, 2015.
In the European Union, the dossier of the national marketing
authorization (MA) variations for Somatuline® Autogel®
120mg injection has been validated by all national 25 drug regulatory
authorities. The first decisions are expected by Q2 2015.
The regulatory submissions and variations were supported by the results
of the 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 and European regulatory
authorities have accepted the filing for Somatuline®
in the treatment of GEP-NETs and that the dossier in the US has been
granted priority review. We are excited about the potential benefits
Somatuline® could bring to patients suffering
from this debilitating disease”.
The data from CLARINET® is purely investigational, as
Somatuline® is not authorized for the indication of treatment
of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any
market. In many countries where it is marketed as Somatuline®
Autogel®, Somatuline® is approved for treatment of
acromegaly and for the symptoms associated with neuroendocrine tumors,
which can include the treatment of GEP-NET patients experiencing
symptoms from carcinoid syndrome, and Somatuline® is approved
in many countries for the treatment of acromegaly. Somatuline®
Depot is approved in the US for the treatment of acromegaly but not for
the treatment of GEP-NETs or the symptoms thereof.
About gastroenteropancreatic neuroendocrine tumors
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are serious and
rare types of cancer. They constitute an 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®
The active substance in Somatuline® [(Somatuline®
Autogel® / Somatuline® Depot) (lanreotide)
Injection 120 mg (referred to as Somatuline®)] is lanreotide
acetate, a somatostatin analogue that inhibits the secretion of several
endocrine, exocrine and paracrine amines and peptides.. It has been
shown to be effective in inhibiting the secretion of GH and certain
hormones secreted by the digestive system. Somatuline® is
marketed as Somatuline® Depot within the United States and as
Somatuline® Autogel® in other countries where it
has marketing authorization, including various EU Member States.
Somatuline® was initially developed and continues to be used
for the treatment of acromegaly in many countries, including the United
States, where it 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® is not
currently indicated as an antitumor agent for the treatment of GEP-NETs.
Somatuline® is approved for the treatment of symptoms
associated with neuroendocrine tumors in many markets, but is not
approved within the United States for this indication.
Important Safety Information about Somatuline®
The most commonly reported adverse drug reactions following treatment
with lanreotide are gastrointestinal disorders and cholelithiasis. In
addition there have been reports of changes to glucose regulation,
levels of liver enzymes, changes to heart rate, injection site and
allergic reactions. The product information should be consulted for a
complete list of undesirable effects, warnings and precautions and
contraindications for use.
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 from CLARINET® showed that investigational treatment with
Somatuline® substantially prolonged time to disease progression or death
versus placebo (hazard ratio 0.47, p=0.0002). Safety data generated from
the CLARINET® study were 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,
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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:
For further information:
Media
Didier Véron
Senior
Vice-Président, Public Affairs and Communication
Tel.: +33 (0)1 58
33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Brigitte
Le Guennec
Media and Public Relations Manager
Tel.: +33
(0)1 58 33 51 17
Fax: +33 (0)1 58 33 50 58
E-mail: brigitte.le.guennec@ipsen.com
or
Financial
Community
Stéphane Durant des Aulnois
Investor
Relations Director
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58
33 50 63
E-mail: stephane.durant.des.aulnois@ipsen.com
or
Thomas
Peny-Coblentz, CFA
Investor Relations Deputy Director
Tel.:
+33 (0)1 58 33 56 36
Fax: +33 (0)1 58 33 50 63
E-mail:thomas.peny-coblentz@ipsen.com
Source: Ipsen
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