BUSINESS WIRE: Initiation of Two Phase II Studies ...

BUSINESS WIRE: Initiation of Two Phase II Studies with Ipsen’s Proprietary
BIM 23A760

First-in-Class Chimeric Compound in the Treatment of Acromegaly and
Carcinoid Syndrome Due to Neuroendocrine Tumors



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PARIS --(BUSINESS WIRE)--15.03.2010--

Regulatory News:

Ipsen (Paris:IPN) announced today the initiation of dosing in two phase II
clinical studies to evaluate efficacy and safety of BIM 23A760 in two
groups of patients, one suffering from carcinoid syndrome due to
neuroendocrine tumors, the other from acromegaly.

“After the encouraging signs of efficacy observed in the first clinical
studies in healthy as well as acromegalic volunteers, we look forward to
further investigating BIM 23A760 efficacy and safety in patients with
neuroendocrine tumors or acromegaly. This very promising compound is core
to Ipsen’s strategy to enhance its fast-growing and competitive
endocrinology franchise, featuring among other drugs Somatuline^®, a
somatostatin analogue developed and marketed on a global scale” said
Stéphane Thiroloix, Executive Vice-President, Corporate Development, Ipsen.

About BIM 23A760

BIM 23A760 has been designed and developed by Ipsen’s research team using
its validated peptide engineering platform. This first-in-class innovative
chimeric compound bears within a single molecule two pharmacological
moieties, i.e. a somatostatin analog and a dopamine agonist which act
synergistically following activation of those receptors in disorders such
as acromegaly and neuroendocrine tumors. The design of BIM 23A760 is based
on a novel concept in molecular biology regarding the amplification of
intracellular signalling when engaging simultaneously two receptors with
their respective ligands. The molecule targets two patho-physiological
pathways among the most commonly associated with pituitary tumors: Growth
hormone and prolactin. Aside from the symptomatic treatment of acromegaly
and carcinoid syndrome due to neuroendocrine tumors, BIM 23A760 might
potentially also reduce the tumor size, thereby eliminating some of the
shortcomings of the treatments currently available. Ipsen is currently
studying this molecule whose spectrum of activity is wider than that of
currently marketed somatostatin analogues.

About the phase II trial in acromegaly

The clinical trial is a phase II open, randomized, parallel group, non
comparative multicenter study to assess the efficacy and safety of repeated
subcutaneous (s.c.) administration of different doses of BIM 23A760 on
growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels in
patients with acromegaly after 6 months of treatment.

This clinical trial follows phase I and IIa trials. In the phase I, BIM
23A760 administration in healthy volunteers potently suppressed prolactin
levels and statistically significant reductions in IGF-1 levels were
observed. In the phase IIa study, the exposure to BIM 23A760 in acromegalic
patients, exhibited a 66–74% mean maximum reduction in growth hormone (GH)
levels. A dose dependent tendency for a more pronounced and longer GH
inhibition was also observed. Additionally, a reduction in IGF-1 levels was
seen in both dosage (1 mg and 4 mg). BIM 23A760 was well tolerated at both
dosages.

About acromegaly

Acromegaly is a disorder caused by the over production of growth hormone
due to a benign tumor of the anterior pituitary gland. This relatively rare
disorder occurs in approximately 90 out of every one million people
(90/1,000,000). Both men and women are affected. Approximately 50% of the
diagnosed patients receive a drug therapy.

About the phase II trial in neuroendocrine tumors

The clinical trial is a phase II, open, adaptive, dose escalating,
multicentre titration study to assess the efficacy and safety of repeated
s.c. administration of different doses of BIM 23A760 for the treatment of
carcinoid syndrome in patients affected with neuroendocrine tumors on
patient’s overall satisfaction in terms of symptom relief after 6 months of
treatment.

About Carcinoid tumors

Carcinoid tumors are rare diseases affecting about 2.5 to 5 out of 100 000
people. Most of them develop in the gastrointestinal tract. The
hypersecretion of substances by the tumor, in particular serotonin, results
in symptoms, mainly diarrhea and flushing. The treatment includes
symptomatic control as well as tumor reduction.

About Ipsen

Ipsen is a global biotechnology specialty care company with total sales in
excess of 1 billion euros in 2009, and total worldwide staff of more than
4,400. Its strategy is based on fast growing specialty care drugs in
oncology, endocrinology, neurology and hematology, and primary care drugs,
significantly contributing to research financing. This strategy is also
supported by an active policy of partnerships. Ipsen’s specific Research &
Development (R&D) centers and peptide & protein engineering platform give
the Group a competitive edge. More than 800 people are dedicated to the
discovery and development of innovative drugs for patient care. In 2009,
R&D spend reached close to EUR200 million, representing more than 19% of
total Group sales. Ipsen’s shares are traded on Segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible to
the “Service de R?glement Différé” (“SRD”) and the Group is part of the SBF
120 index. For more information on Ipsen, visit our website at
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. 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. Notably, future currency
fluctuations may negatively impact the profitability of the Group and its
ability to reach its objectives. Actual results may depart significantly
from these targets given the occurrence of certain risks and uncertainties.
The Group does not commit nor gives any guarantee that it will meet the
targets mentioned above. Furthermore, the Research and Development process
involves several stages each of which involve 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 favourable 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 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.

[CT]

Kontakt: Ipsen Media Didier Véron Director, Public Affairs and Corporate
Communications Tel.: +33 (0)1 58 33 51 16 Fax: +33 (0)1 58 33 50 58 E-mail:
didier.veron@ipsen.com or Financial Community David Schilansky Investor
Relations and Financial Officer Tel.: +33 (0)1 58 33 51 30 Fax: +33 (0)1 58
33 50 63 E-mail: david.schilansky@ipsen.com or Pierre Kemula Investor
Relations Manager Tel.: +33 (0)1 58 33 60 08 Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com

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