|[January 17, 2013]
Teijin Pharma to Launch Ipsen's Somatuline® Subcutaneous Injection in the Treatment of Acromegaly and Pituitary Gigantism in Japan
TOKYO & PARIS --(Business Wire)--
Pharma Limited, the core company of the Teijin
Group's healthcare business, and Ipsen
(Euronext: IPN; ADR: IPSEY) (Paris:IPN), today announced the launch of
Somatuline® 60/90/120 mg for subcutaneous injection in Japan
for the treatment of acromegaly and pituitary gigantism (when response
to surgical therapies is not satisfactory or surgical therapies are
difficult to perform). In Japan, Teijin Pharma holds the rights to
develop and market the drug.
Somatuline® is a synthetic somatostatin analog developed by
Ipsen approved in more than 60 countries worldwide. In Japan, Somatuline®
is available in a differentiated and enhanced presentation with a
pre-filled syringe that does not need reconstitution and with a
retractable needle that enhances safety for caregivers; Somatuline®'s
long-lasting effects enable one administration every four weeks.
Kentaro Arao, President of Teijin Pharma said: "Somatuline®,
used in more than 60 countries worldwide, is highly regarded by the
medical profession and patients for its long-lasting effects and
user-friendly dosing devices. We are pleased to launch Somatuline®
in Japan, confident that it will offer patients a beneficial treatment
option to control the symptoms of acromegaly, or pituitary gigantism,
for improved quality of life."
Christophe Jean, Ipsen's Executive Vice-President, Operations
said: "We are privileged to have Teijin as our partner in Japan and
pleased that Somatuline® is now also available
to Japanese patients suffering from acromegaly and pituitary gigantism."
About the agreements with Teijin
In the framework of the successive agreements signed between Teijin and
Ipsen, Teijin is entitled to develop and commercialize Somatuline®
in Japan and Ipsen will manufacture and supply the finished product to
Teijin. Ipsen will record the supply sale to Teijin in its sales line.
Acromegaly is a metabolic disease in which pituitary gland tumors cause
excess secretion of hormone responsible for growth of bone and muscle.
This results in a variety of symptoms, including protrusion of the brow
and jaw, enlargement of extremities such as nose, lips, hands and feet,
headaches, and loss of outer field vision. The term pituitary gigantism
is used when the condition occurs in children, since it results in
excess height and growth of feet and hands.
Progression of acromegaly is so slow that the disease often goes
unnoticed by the person afflicted as well as the people around them.
Eventually it can lead to metabolic complications, such as diabetes,
hypertension, angina, myocardial infarction or cerebrovascular disease.
Acromegaly also increases the risk of malignant tumors, so patients are
two to five times more likely to die early than healthy individuals,
resulting in a shortened lifespan with a mean reduction of about 10
In Japan, the number of patients with acromegaly is thought to be about
10,000 including subjects1 that are not yet diagnosed for
acromegaly. Acromegaly is designated as an intractable disease, so
patients are eligible to receive publicly subsidized treatment. The most
common treatment is surgical resection of the tumor, but drug therapy or
radiation therapy is usd when the tumor is too large to remove
surgically, or when excess hormone secretion persists even after
surgery. To date, drug therapy has consisted of somatostatin analogues
(somatostatin is a hormone that inhibits secretion of growth hormone).
However, at present there is only a single somatostatin agonist
available in Japan, leaving unmet needs for additional treatment options.
The active substance in Somatuline® and Somatuline® Autogel®
is lanreotide, which inhibits the growth and secretion of several
endocrine, exocrine and paracrine hormones. It is particularly effective
in inhibiting the secretion of growth hormone.
Somatuline® (also marketed as Somatuline® Autogel®
outside the USA and Somatuline® Depot ® in the
USA) is a sustained release formulation for injection containing
lanreotide, a somatostatin analogue (a hormone that inhibits the release
of growth hormone).
Somatuline® was initially developed and continues to be used
mainly in the treatment of acromegaly, a disorder caused by the
overproduction of growth hormone or prolactin due to a benign tumour of
the anterior pituitary gland. This product subsequently underwent
further development in Europe in the treatment of symptoms associated
with neuroendocrine tumours (particularly of a carcinoid type).
Ipsen believes that the Somatuline® Autogel®
formulation, to which it holds the patent, represents a major
technological advance. As far as the Group is aware, this represents the
first semisolid formulation for injection where the active substance
itself controls the sustained release.
Somatuline® Autogel® releases the active substance
over a period of at least 28 days, thus requiring just one injection per
month. In some countries, for acromegaly patients well-controlled with
60mg or 90mg every four weeks, an extended dosing interval of Somatuline®
120mg given every 6 to 8 weeks, may be used, reducing the number on
injections per year.
This product is presented in a pre-filled syringe for convenient
administration. In some countries, Somatuline® is available
in a differentiated and enhanced presentation with a pre-filled syringe
that does not need reconstitution and with a retractable needle that
enhances safety for caregivers. As of today, Somatuline® and
Somatuline® Autogel® are marketed in more than 60
countries (including 25 in Europe, the USA, Canada and Japan) for the
treatment of acromegaly and neuroendocrine tumors.
About the Teijin Group
Teijin (TSE 3401) is a technology-driven global group offering advanced
solutions in the areas of sustainable transportation, information and
electronics, safety and protection, environment and energy, and
healthcare. 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 150 companies and around 17,000 employees spread out over
20 countries worldwide. It posted consolidated sales of JPY 854.4
billion (USD 9.9 billion) and total assets of JPY 762.1 billion (USD 8.8
billion) in the fiscal year ending March 31, 2012. Please visit www.teijin.co.jp/english.
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.1 billion in 2011. Ipsen's ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by four franchises:
neurology / Dysport®, endocrinology / Somatuline®,
uro-oncology / Decapeptyl® and hemophilia. 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 2011, R&D expenditure totaled more than €250 million, above
21% of Group sales. The Group has total worldwide staff of close to
4,500 employees. 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 on Ipsen,
Ipsen 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.
Moreover, the targets described in this document were prepared without
taking into account external growth assumptions and potential future
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based on data and assumptions regarded as reasonable by the Group. These
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and not exclusively on historical data. Actual results may depart
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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
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1 "The Japanese journal of endocrinology(2006)",
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