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"PRIMARYS" Study Investigators Observed Clinically Relevant Results in an Investigational Phase III Study with Somatuline®

  "PRIMARYS" Study Investigators Observed Clinically Relevant Results in an
  Investigational Phase III Study with Somatuline® Autogel® 120 mg in Patients
  with Acromegaly

 Statistical Significance Not Met for the Primary Endpoint, but Tumor Volume
           Reduction Observed in a Majority of Acromegalic Patients

Business Wire

PARIS -- June 17, 2013

Ipsen (Euronext: IPN; ADR: IPSEY)  today announced the results of an
international phase IIIB study, PRIMARYS, assessing an investigational use of
Somatuline^® Autogel^® (lanreotide) 120mg as first line therapy in newly
diagnosed acromegaly patients with a macroadenoma. While PRIMARYS did not meet
statistical significance with respect to its primary efficacy endpoint,
investigators observed clinically relevant tumor volume reductions, in a
majority of patients. Data from secondary biomarker endpoints of growth
hormone (GH) and insulin-like growth factor-1 (IGF-1) levels were further
supportive of these findings. Baseline GH level was the main factor identified
as potential predictor for tumor response to primary therapy. Data were
presented at the Endocrine Society^1 annual congress (ENDO Congress, San
Francisco, USA) on June 16^th, 2013.

PRIMARYS is the first study of a somatostatin analogue in such a large and
homogeneous population (90 treatment-naïve acromegalic patients with
macroadenoma) to evaluate tumor volume reduction as the primary endpoint using
Magnetic Resonance Imaging (MRI) with a very robust and unique methodology for
central assessment.

Pr John S. Bevan, co-Principal Investigator of the study, Head of
Endocrinology at Aberdeen Royal Infirmary and Honorary Professor of
Endocrinology at Aberdeen University (UK) said: “The results not only show a
clinically relevant effect on the volume of the macroadenoma but are also very
convincing for GH and IGF-1 lowering and improvement in clinical symptoms.
Interestingly, all these beneficial effects can be observed after only 3
injections of Somatuline^® Autogel^® 120mg. The overall safety profile
observed during this one year study was consistent with the safety profile of
Somatuline^® in acromegalic patients – despite the high doses administered, no
patient had to stop treatment due to gastro-intestinal adverse effects. This
study reinforces the overall positive benefit/risk of Somatuline^® Autogel^®
120mg in acromegalic patients and provides new data to further explore its
potential use as an alternative to frontline surgery for treatment-naïve
patients with GH-secreting macroadenoma”.

Pr Philippe J. Caron, Investigator of PRIMARYS, Head of Endocrinology and
Metabolic diseases Unit, Toulouse (France) added: “We can be very proud of
this unique and well-designed study. Although the primary endpoint was not
statistically met, we observe clinically relevant results as Somatuline^®
Autogel^® 120mg was associated with early and sustained reduction in pituitary
adenoma volume. 63% of patients achieved 20% or more volume reduction as well
as reduction in GH/IGF-1 levels and improvement in clinical symptoms”.

Claude Bertrand, Executive Vice-President, Research & Development - Chief
Scientific Officer, Ipsen (France) concluded: “Not only does this study
confirm efficacy and safety of Somatuline^® Autogel^® 120mg, but PRIMARYS also
provides very interesting scientific information concerning an investigational
use of Somatuline® Autogel® 120mg in a large cohort of newly diagnosed
acromegalic patients. With this study, Ipsen demonstrates its commitment in
endocrinology, exploring innovative solutions to treat newly diagnosed
acromegalic patients. ”

About PRIMARYS Phase IIIB study

PRIMARYS (PRIMARY treatment in macroadenoma acromegaly with Somatuline^®) is a
unique, open label, 1-year study, evaluating an investigational use of
Somatuline^® Autogel^® 120mg (lanreotide) in 90 patients with newly diagnosed
acromegaly. Spanning 9 countries worldwide, it is the only somatostatin
analogue study assessing tumor volume reduction as a primary endpoint and with
a rigorous central reading methodology involving 3 neuroradiologists.

Somatuline^® Autogel^® 120mg was initiated in patients with macroadenoma, with
one injection every 4 weeks and patients tumor volume assessment every 12
weeks (using MRI), GH, IGF-1, clinical symptoms, biochemical parameters,
quality of life and safety over a total period of 48 weeks. In the Intention
To Treat (ITT) population, the proportion of patients achieving ≥20% tumor
volume reduction from baseline to week 48 was 63% (95% CI, 52%-73%), according
to the neuroradiologist with the highest repeatability and lowest
intra-variability (primary analysis), and from 72% (95% CI, 61-81%) to 75%
(95% CI, 65-84%) according to two other readers for whom CIs for the
proportion of patients with tumour response was above the protocol-predefined
arbitrary 55% threshold.

Five patients prematurely discontinued the PRIMARYS study due to adverse
events, among which three were considered as related to the study medication
by the investigator (leakage of cerebral fluid, deterioration of hypertension
and hair loss).

Most patients reported mild (57/90 [63%]) and/or moderate AEs (36/90 [40%]),
but only 5/90 discontinued due to AEs (6%). In the absence of a control group,
it is challenging to determine whether adverse events were related to the
study drug. The safety profile observed in the study is consistent with the
known safety profile of Somatuline^®. The most frequent treatment emergent
adverse events were gastrointestinal disorders, alopecia, cholelithiasis and
fatigue.

About Somatuline^®

The active substance in Somatuline^® Depot / Somatuline^® Autogel^® is
lanreotide acetate, a somatostatin analogue that inhibits the secretion of
several endocrine, exocrine and paracrine functions. It is particularly
effective in inhibiting the secretion of GH and certain hormones secreted by
the digestive system.

Somatuline^® is available in some countries 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^®
was initially developed and continues to be used for the treatment of
acromegaly. It was subsequently developed and is now also used for the
treatment of symptoms associated with neuroendocrine tumors in many markets,
but not in the US where it is still currently under development and yet to be
approved for this indication.

As of 13^th May 2013, Somatuline^® (30mg) and Somatuline^® Autogel^® (60mg,
90mg,120mg) were marketed in over 55 countries (including 29 in Europe) and
registered in 70 countries (including 30 in Europe) for the treatment of
acromegaly and/or neuroendocrine tumors.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with total sales
exceeding €1.2 billion in 2012. 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 2012, R&D expenditure totaled close to €250
million, representing more than 20% of Group sales. The Group has close to
4,900 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 on Ipsen, visit www.ipsen.com.

Forward Looking Statement

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based on the Group’s management strategy, current views and assumptions. Such
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actual results, performance or events to differ materially from those
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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
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registration documents filed with the French Autorité des Marchés Financiers.

^1 Oral presentation: OR27-3High Dose Lanreotide Autogel Treatment Produces
Early and Sustained Reductions in Tumor Volume and GH/IGF-1 Levels in
Treatment-Naïve Acromegalic Patients with GH-Secreting Pituitary Macroadenoma:
The PRIMARYS Study - Featured poster presentation: FP27-1Potential Predictors
of Macroadenoma Volume Reduction After Primary Therapy With Lanreotide Autogel
in a Large Treatment-Naïve Acromegalic Population

Contact:

Fondation Ipsen
Media
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
didier.veron@ipsen.com
or
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
pierre.kemula@ipsen.com
or
Brigitte Le Guennec
Media and Public Relations Officer
Tel.: +33 (0)1 58 33 51 17
Fax: +33 (0)1 58 33 50 58
brigitte.le.guennec@ipsen.com
or
Thomas Peny-Coblentz
Investor Relations Manager
Tel.: +33 (0)1 58 33 56 36
Fax: +33 (0)1 58 33 50 63
thomas.peny-coblentz@ipsen.com
 
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