Market Overview

Ipsen: Somatuline® Autogel® 120 mg Receives Japanese Approval for a New Indication for the Treatment of Gastro-Entero-Pancreatic Neuroendocrine Tumors

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Regulatory News:

Ipsen ((Euronext: IPN, OTCMKTS:IPSEY) and Teijin Pharma Limited, the core
company of the Teijin Group's healthcare business, today announced that
Teijin Pharma has received approval from the Japanese Ministry of
Health, Labour and Welfare for Ipsen's subcutaneous drug Somatuline®
(lanreotide) for the treatment of gastroenteropancreatic neuroendocrine
tumors (GEP NET). The drug is approved in Japan for the treatment of
acromegaly and pituitary gigantism since 2012.

The request for the additional approval was filed in July 2016, based on
Ipsen's investigational, pivotal phase III randomised placebo-controlled
trial (CLARINET) in 204 patients with GEP NET conducted in 14 countries,
and an open-label single group multicenter Phase II trial (J-001) in 32
patients with NET that Teijin Pharma conducted in Japan. This approval
establishes Somatuline® as the first drug available in Japan for the
treatment of pancreatic NET.

Harout Semerjian, Executive Vice-President & President, Specialty
Care International & Global Franchises
said: "We are pleased
that Somatuline
® is now also available for
Japanese patients suffering from gastrointestinal and pancreatic
neuroendocrine tumors. In line with our commitment to serve NET patients
worldwide, this is a significant step after our partner Teijin launched
Somatuline
® for the treatment of acromegaly and
pituitary gigantism in Japan in January 2013."

Akihisa Nabeshima, President of Teijin Pharma said: "It is our
great pleasure to now have the capacity to provide a new therapeutic
option to NET patients in Japan. We will continue to focus on drug
discovery and improve the quality of life of patients by offering them
new treatment options to fulfill unmet medical needs."

About Neuroendocrine Tumors
NETs are malignant tumors
arising from neuroendocrine cells. Most of the NET tumors present with
metastasis and are discovered fortuitously. In some patients, excess
hormones secreted from a NET can lead to severe diarrhea, peptic ulcers
or hypoglycemia. While incidence rates are relatively rare, at about 3.5
gastrointestinal NET patients and 1.3 pancreatic NET patients per
100,000 people in Japan, the number of patients has been increasing year
by year due to disease awareness and better diagnosis1.

The primary treatment for NETs is removal by surgery, but if this is not
possible as the disease is usually disseminated, or if a tumor relapses
following surgery, another option is a medical treatment.

About Somatuline®

The active substance in Somatuline® is lanreotide acetate, a
somatostatin analogue that inhibits the secretion of several endocrine,
exocrine and paracrine functions. 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. Somatuline® is indicated for the treatment of
acromegaly and neuroendocrine tumors in 70 countries.

< Product Summary >

BRAND NAME   SOMATULINE® 60 mg for s.c. Injection;

SOMATULINE® 90 mg for s.c. Injection;

SOMATULINE® 120 mg for s.c. Injection

GENERIC NAME   lanreotide acetate
DOSAGE FORM   Sustained -release Injection (pre-filled syringe with needle)
INDICATIONS   To ameliorate oversecretion of growth hormone and/or IGF-I
(Somatomedin-C) as well as improvement of symptoms associate with
the following diseases:

Acromegaly, Pituitary gigantism (when response to surgical
therapies has not been satisfactory or surgery is difficult to be
performed)

 

Gastroentero-pancreatic neuroendocrine tumors

DOSAGE AND ADMINISTRATION   In adults, 90 mg of lanreotide is usually administered by deep
subcutaneous injection at 4-week intervals for 3 months, followed by
60, 90 or 120 mg every 4 weeks. The dosage may be adjusted according
to the patients' clinical condition.
 

In adults, 120 mg of lanreotide is usually
administered by deep subcutaneous injection at 4-week intervals

The additional indication is described in the
underlined part.

The indication for Gastroentero-pancreatic NETs is
approved for SOMATULINE
®
120 mg for s.c. Injection alone.

About the Teijin Group
Teijin (TSE: 3401) is a
technology-driven global group offering advanced solutions in the areas
of environmental value; safety, security and disaster mitigation; and
demographic change and increased health consciousness. Its main fields
of operation are high-performance fibers such as aramid, carbon fibers &
composites, healthcare, films, resin & plastic processing, polyester
fibers, products converting and IT. The group has some 170 companies and
around 19,000 employees spread out over 20 countries worldwide. It
posted consolidated sales of JPY741.3 billion (USD 6.5 billion) and
total assets of JPY 964.1 billion (USD 8.5 billion) in the fiscal year
ending March 31, 2017. Please visit www.teijin.com

About Ipsen
Ipsen is a global specialty-driven
biopharmaceutical group focused on innovation and specialty care. The
group develops and commercializes innovative medicines in three key
therapeutic areas - Oncology, Neurosciences and Rare Diseases. Its
commitment to oncology is exemplified through its growing portfolio of
key therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales close to €1.6 billion in
2016, Ipsen sells more than 20 drugs in over 115 countries, with a
direct commercial presence in more than 30 countries. Ipsen's R&D is
focused on its innovative and differentiated technological platforms
located in the heart of the leading biotechnological and life sciences
hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has
about 5,100 employees worldwide. Ipsen is listed in Paris (Euronext:
IPN) and in the United States through a Sponsored Level I American
Depositary Receipt program (OTCMKTS:IPSEY). For more information on Ipsen,
visit www.ipsen.com.

Forward Looking Statement
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 favorable 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.

The risks and uncertainties set out are not exhaustive and the reader is
advised to refer to the Group's 2016 Registration Document available on
its website (www.ipsen.com).

1 Tetsuhide Ito et al J Gastroenterol (2015) 50:58-64

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