Ipsen`s Partner Roche Announces That Taspoglutide Meets Its Primary Endpoint in the First Phase III Clinical Trial
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Taspoglutide weekly demonstrated significant superiority on HbA1c over
twice-daily exenatide in the treatment of patients with type 2 diabetes
PARIS--(Business Wire)--
Regulatory News:
Ipsen (Paris: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: 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
Copyright Business Wire 2009
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