EMEA Recommends Marketing Authorisation of Ipsen´s Adenuric(R) (Febuxostat) for the Treatment of Chronic Hyperuricaemia in Gout

Adenuric(R) Represents the First Major Treatment of Gout for More Than Forty Years

Regulatory News:

Ipsen (Paris:IPN) announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
provided a positive opinion for Adenuric(R) (febuxostat) 80 mg and 120
mg tablets for the treatment of chronic hyperuricaemia in gout and
recommended it for marketing authorisation. The CHMP recommendation
will now be forwarded to the European Commission for final marketing
approval, which typically occurs within 60 to 90 days. Following
marketing approval, Adenuric(R) will become, since 1964, the first
significant treatment alternative for chronic hyperuricaemia available
to gout patients.

Adenuric(R) is to be 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). The detailed recommendations for the use of this product
will be described in the Summary of Product Characteristics (SPC), to
be made available after the medication receives marketing
authorisation from the European Commission.

Once the product receives its marketing authorisation and its
price is agreed, Febuxostat will be marketed by Ipsen in France under
the brand name Adenuric(R). Outside France, the commercialisation of
the product will be partnered.

Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen,
said, "We are very proud to receive this positive opinion for
Adenuric(R) from the EMEA, and look forward to bringing this new
molecule to market, pending European Commission approval. This
innovative drug pioneers the first major treatment of gout for more
than 40 years. It confirms Ipsen´s ability to continue to bring to the
market important new treatment options for severely debilitating
diseases."

About Adenuric(R) (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. Febuxostat is licensed to Ipsen for
Europe from Teijin Pharma Limited, Tokyo.

The EU submission includes 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 greater than1.5 -