Teijin Pharma to Launch Ipsen's Somatuline® Subcutaneous Injection in the Treatment of Acromegaly and Pituitary Gigantism in

  Teijin Pharma to Launch Ipsen's Somatuline® Subcutaneous Injection in the
  Treatment of Acromegaly and Pituitary Gigantism in Japan

Business Wire

TOKYO & PARIS -- January 17, 2013

Regulatory News:

Teijin 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

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.

About acromegaly

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 years.

In Japan, the number of patients with acromegaly is thought to be about 10,000
including subjects^1 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 used 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.

About Somatuline^®

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.

About Ipsen

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, visit www.ipsen.com.

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 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 Generics 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. 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 fulfill 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.

^1 “The Japanese journal of endocrinology(2006)”, “Pituitary(1999)”


For further information:
Public Relations Office
Teijin Limited
+81 3 3506 4055
Didier Véron
Vice President, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
Financial Community
Pierre Kemula
Vice President, Corporate Finance, Treasury and Financial Markets
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
Stéphane Durant des Aulnois
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 09
Fax: +33 (0)1 58 33 50 63
Press spacebar to pause and continue. Press esc to stop.