Microsoft word - pr emerge2 phase iii results en.doc

Ipsen’s partner Roche announces that Taspoglutide
meets its primary endpoint in the first phase III clinical trial
Taspoglutide weekly demonstrated significant superiority on HbA1c over twice-
daily exenatide in the treatment of patients with type 2 diabetes
Paris (France), 29 October 2009 - Ipsen (Euronext: FR0010259150; IPN), an innovation-driven
global specialty pharmaceutical group, today announced that its partner Roche has disclosed
the results of a first phase III clinical study using Taspoglutide, the first human once weekly
glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s Research. Results from
Roche’s Phase III study T-EMERGE 2 met its primary endpoint of change in HbA1c
(subcutaneous weekly taspoglutide versus subcutaneous twice-daily exenatide, as add-on to
metformin, a thiazolidinedione [TZD], or metformin and a TZD). A superiority versus exenatide
was demonstrated.
This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar
regulation. GLP-1 analogues, which stimulate insulin secretion and suppress glucagon
secretion, are true innovations in the diabetes field.
The results showed that taspoglutide demonstrated superior HbA1c reduction versus exenatide
following 24 weeks of treatment. The study analysis included 1,189 patients, equally randomized
into three active arms (taspoglutide 10 mg once weekly, taspoglutide 10 mg once weekly titrated
up to 20 mg once weekly after 4 weeks, and exenatide 10 mcg twice daily). Taspoglutide was
generally well tolerated. The most frequently reported adverse events among taspoglutide and
exenatide treated patients were nausea and vomiting.
About T- EMERGE 2
T-EMERGE 2 is an open-label, 24-week core study, to demonstrate non-inferiority (with a pre-specified
test for superiority) versus twice-daily exenatide, involving 1189 patients, equally randomized into three
active arms (taspoglutide at doses of 10 and 20-mg, and exenatide 10 mcg). All patients continue into
long-term extension of the study.
About the T-EMERGE Program
Roche’s T-EMERGE Phase III clinical trial programme is designed as multicenter, multi-country,
randomized, controlled (active or placebo), double-blind and open studies. Over 6000 patients will be
enrolled in the eight studies that comprise the T-EMERGE programme. Studies include two parallel
taspoglutide arms including 10 mg once weekly and 10 mg once weekly titrated up to 20 mg once weekly
after 4 weeks. Four of the eight studies have active comparators, including exenatide, sitagliptin, insulin
glargine and pioglitazone.

About Taspoglutide (R1583)
Taspoglutide was selected from a family of human once-weekly long-acting glucagon-like peptide-1 (GLP-
1) analogues with structural modifications which confer intrinsic controlled release properties. Ipsen is the
originator of the concept of matrix free sustained release formulation applied to therapeutic peptides and
proteins. Taspoglutide is being developed as a novel and innovative treatment for patients with type 2
diabetes mellitus, the fourth leading cause of death in most developed countries. The structure of the
molecule is similar to that of the natural human hormone GLP-1, and has the potential for intervals of up to
two weeks in between administration without the use of a matrix

About Diabetes
Diabetes is a disease characterized by excess blood glucose due to a deficiency in insulin availability
and/or resistance to its action. Type 2 diabetes accounts for 90% to 95% of all diabetes cases worldwide
and occurs almost entirely in adults. Complications from diabetes, such as coronary artery and peripheral
vascular disease, stroke, diabetic neuropathy, amputations, renal failure and blindness, are resulting in
increasing disability, reduced life expectancy and enormous health cost for virtually every society.
According to current estimates by the World Health Organization, the number of people with diabetes is
set to more than double in the next 20 years to over 300 million by the year 2025.
About the agreement
Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide
rights to develop and market Taspoglutide, except in Japan where these rights are shared with Teijin and
in France where Ipsen retained co-marketing rights.

About Ipsen
Ipsen is an innovation-driven global specialty pharmaceutical group with over 20 products on the market
and a total worldwide staff of nearly 4,200. Its development strategy is based on a combination of
specialty medicine, which is Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology,
neurology and haematology), and primary care products which contribute significantly to its research
financing. The location of its four Research & Development centres (Paris, Boston, Barcelona, London)
and its peptide and protein engineering platform give the Group a competitive edge in gaining access to
leading university research teams and highly qualified personnel. More than 800 people in R&D are
dedicated to the discovery and development of innovative drugs for patient care. This strategy is also
supported by an active policy of partnerships. In 2008, Research and Development expenditure was about
€183 million, close to 19% of consolidated sales, which amounted to €971 million while total revenues
exceeded €1 billion. 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 Règlement 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.

For further information:

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: [email protected] David Schilansky
Pierre Kemula
Investor Relations and Financial Officer

Source: http://www.ipsen.cz/dokumenty/20091029___taspoglutide_phase_iii_10.pdf