Market Overview

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


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
® 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


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

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,

Forward Looking Statement
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objectives and targets contained herein are based on the Group's
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1 Tetsuhide Ito et al J Gastroenterol (2015) 50:58-64

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