Ipsen: Adenuric® (Febuxostat) Receives Marketing Authorisation in the European Union

Regulatory News:
Ipsen (Paris:IPN) today announced that the European Commission granted

marketing authorisation for Adenuric® (febuxostat) for the treatment of chronic hyperuricaemia in gout.

Adenuric® thus

pioneers the first major treatment alternative for gout, a severe

debilitating disease, for more than 40 years.
"Recent surveys confirm that management of gout is often

suboptimal, with less than half of patients receiving appropriate

lifestyle advice or urate lowering treatment" said Michael Doherty

Professor of Rheumatology at the University of Nottingham (UK) and

Co-chair of the 2006 EULAR Task Force for the Recommendations on

Diagnosis and Management of Gout. "Recent European (EULAR)

Recommendations emphasise the aim of "cure" by lowering serum urate

levels below the saturation point for crystal formation. For some

patients, the existing urate lowering therapies have limitations in

terms of suitability or side effects. The availability of a new

effective therapy that allows the therapeutic target to be achieved will

improve the physicians armamentarium and ultimately benefit the

population of patients with gout."
Adenuric® (febuxostat)

80 mg and 120 mg tablets are indicated for the treatment of chronic

hyperuricaemia for conditions in which urate deposition has already

occurred (including a history, or presence of, tophus and/or gouty

arthritis).
Adenuric® will be

marketed by Ipsen in France. Outside France, the commercialisation of

the product will be partnered.
About the marketing authorisation
(The European Public Assessment Report (EPAR) summary will be accessible

at http://www.emea.europa.eu).

This decision follows the filing by Ipsen, of an application for

marketing authorisation for Adenuric® in the European Union in 2006. A positive opinion, recommending to grant

a marketing authorisation was adopted by the Committee for Medicinal

Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on

21 February 2008.
The EU submission,included two of the largest industry sponsored studies

to date studying treatment of chronic gout patients. The goal of chronic

gout treatment is per EULAR guidelines (European League Against

Rheumatism) to reduce and maintain sUA levels below 6 mg/dL. Febuxostat

demonstrated superior ability to lower and maintain in patients, serum

uric acid at a level inferior to 6 mg/dl compared to conventionally used

doses of allopurinol (febuxostat 80 and 120 mg: 51 & 63 % resp. vs.

allopurinol: 22%). In addition, one phase III study showed that gout

patients with mild to moderate renal impairment (serum creatinine >1.5

- ≤2.0 mg/dl) had response rate of 44 and 45

% respectively with febuxostat 80 and 120 mg.
About Adenuric® (febuxostat)
Gout, a particularly painful type of arthritis, is the most frequent

arthritis in men. It is caused by elevated levels of uric acid in the

body: hyperuricaemia. Febuxostat, an oral, once-daily medication, is a

novel non-purine, selective inhibitor of xanthine oxidase studied for

its effects on lowering levels of serum uric acid (sUA) in patients with

gout.
The recommended oral dose of Adenuric® is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dl (357 µmol/l) after 2-4 weeks, Adenuric® 120 mg once daily may be considered. Adenuric® works sufficiently quickly to allow retesting of the serum uric acid

after 2 weeks. The therapeutic target is to decrease and maintain serum

uric acid below 6 mg/dl (357μmol/l). Gout

flare prophylaxis of at least 6 months is recommended at initiation of

treatment with Adenuric®.
Febuxostat is licensed to Ipsen for Europe from Teijin Pharma Limited

Tokyo. In 2003, Ipsen entered into a Research and Development

partnership with Teijin Pharma Limited, the core company of Teijin Group´s

pharmaceutical and home healthcare business. The Teijin group is a

Japanese industrial conglomerate specialising in the businesses of

fibres, films, plastics and information technology (IT) as well as

pharmaceuticals and home healthcare. This partnership covers the

development and subsequent commercialisation of four of Ipsen´s

products by Teijin Pharma in Japan and the development and marketing by

Ipsen in Europe (i.e. European Union and Russia) of febuxostat, a

product owned by Teijin Pharma and known as TMX-67.
About Ipsen
Ipsen is an innovation driven international specialty pharmaceutical

group with over 20 products on the the market and a total worldwide

staff of nearly 4,000. Its development strategy is based on a

combination of specialty products, which are growth drivers, in targeted

therapeutic areas (oncology, endocrinology and neuromuscular disorders)

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 700 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 2007, Research and

Development expenditure was about €185

million, in excess of 20% of consolidated sales, which amounted to €920.5

million while total revenues amounted to €993.8

million. Ipsen´s shares are traded on Segment

A of Eurolist by EuronextTM (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.
Forward-looking statements
The forward-looking statements and targets contained herein are based on

Ipsen´s management´s 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 Research and Development process

involves several stages at each of which there is a substantial risk

that the Group will fail to achieve its objectives and be forced to

abandon its efforts in respect of 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, or that the regulatory authorities will be

satisfied with the data and information provided by the Company. Ipsen

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. Ipsen´s business is subject to the risk

factors outlined in its information documents filed with the French Autorité des Marchés Financiers.