IPSEN: Increlex(R) Receives Marketing Authorisation in the European Union

Regulatory News:

Increlex(R) is the First Recombinant Human Insulin-Like Growth
Factor-1 Therapy Approved in Europe for Severe Primary Igf-1
Deficiency

Ipsen (Paris:IPN) today announced that the European Commission
granted marketing authorisation for Increlex(R) (mecasermin) 10 mg/ml
solution for injection in the European Union.

The indication approved is for the long-term treatment of growth
failure in children and adolescents with severe primary insulin-like
growth factor-1 deficiency (severe primary IGFD).

Increlex(R) was designated as an orphan medicinal product in the
European Union on 22 May 2006. The European marketing authorisation
provides Increlex(R) a ten-year marketing exclusivity for the
treatment of severe Primary IGFD.

In October 2006, Tercica Inc. granted Ipsen the development and
commercialisation rights for Increlex(R) in Europe and certain other
territories; Ipsen is now in the process of launching this drug from
October 2007 in the European Union. According to the terms of the
agreement, the approval of Increlex(R) marketing authorisation in the
European Union triggers a EUR 15 million (approximately US$20 million)
milestone payment by Ipsen to Tercica.

"The effect of growth hormone (GH) is to a major part mediated by
insulin-like growth-factor-1 (IGF-1). If the biochemical steps leading
to the formation of IGF-I are interrupted then patients are suffering
from primary IGF-1 deficiency and cannot respond to GH therapy.
Replacement with IGF-1 is the pathogenetically appropriate therapy in
these instances" said Professor Dr. Michael B. Ranke, Paediatric
Endocrinology Section, University Children's Hospital, University of
Tuebingen, Germany. "Increlex(R) (mecasernim), a recombinant human
insulin-like growth factor-1 (IGF-1) thus opens a new field for the
treatment of previously untreatable children with severely short
stature."

Christophe Jean, Executive Vice-President and Chief Operating
Officer of Ipsen, and Board member of Tercica Inc., said "We are very
pleased that Increlex(R) will be soon available to patients and
physicians for the treatment of growth failure in children and
adolescents with severe primary IGF-1 deficiency. Increlex(R) fits
perfectly in our existing global endocrinology franchise, along with
Somatuline(R) and NutropinAq(R) to provide endocrinologists with a
comprehensive solution for the treatment of patients suffering from
growth disorders."

About the marketing authorisation

(The European Public Assessment Report (EPAR) summary can be
accessed at www.emea.europa.eu)

This decision follows the filing by Tercica Inc., Ipsen's partner,
of an application for marketing authorisation for Increlex(R) in the
European Union in December 2005. The positive opinion, recommending to
grant a marketing authorisation under exceptional circumstances for
Increlex(R), was adopted by the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMEA) on 24 May
2007. Such authorisations are permissible for medicinal products for
which the applicant can demonstrate that comprehensive data cannot be
provided, for example because of the rarity of the condition, as long
as it can be demonstrated on a regular basis that the benefits
outweigh the risks. Every year, Ipsen and Tercica will review with the
EMEA any new information that may become available.

The positive decision of the EMEA is based on clinical data from
76 patients who were treated with Increlex(R) for up to 12.5 years.
The primary endpoint in the pivotal clinical study was height
velocity, which increased from an average of 2.8 cm per year at
baseline to an average of 8.0 cm per year (p less than 0.0001) in the
first year of treatment and 5.8 cm in the second. The growth rate
stabilised at around 4.7 cm per year from the fourth year of
treatment.

About Increlex(R)

Mechanism of action

The active ingredient of Increlex(R) is recombinant human
insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of
growth hormone's effect on statural growth, and must be present for
normal growth of bones and cartilage in children. In severe primary
IGFD, children's' serum IGF-1 levels are low, despite the presence of
normal or elevated GH level. Without adequate IGF-1, children cannot
achieve normal height. In children with this disorder, low IGF-1
levels are due to growth hormone resistance associated with mutations
in GH receptors, post-GH receptor signalling pathways, or to defects
in IGF-1 gene expression. As such, these children cannot be expected
to respond adequately to exogenous GH treatment. Some individuals may
also have a range of metabolic disorders, including lipid
abnormalities, decreased bone density, obesity and insulin resistance.

Indication

The summary of product characteristics defines severe Primary IGFD
as:

-- a height standard deviation score (less than or=) -3.0,

-- basal IGF-1 levels below the 2.5th percentile for age and
gender,

-- GH sufficiency, and

-- the exclusion of secondary forms of IGF-1 deficiency, such as
malnutrition, hypothyroidism, or chronic treatment with
pharmacologic doses of anti-inflammatory steroids.

It is recommended to confirm the diagnosis by conducting an IGF-1
generation test.

Doses

The recommended starting dose is 0.04 mg per kilogram body weight
twice a day. The dose should be tailored for each patient according to
the speed of growth and certain side effects. The maximum dose is 0.12
mg per kilogram twice a day.

Increlex(R) is given by injection under the skin, and the
injection site should be changed with each injection. The injection
should be carried out shortly before or after a meal or snack.

Safety information

The most common side effects with Increlex(R) (seen in more than 1
patient in 10) are hypoglycaemia (low blood sugar levels), thymus
hypertrophy (growth of the thymus gland, a gland below the breastbone
that is involved in producing infection-fighting cells), headache,
hypoacusis (hearing loss), tonsillar hypertrophy (growth of the
tonsils), snoring and injection site hypertrophy (lumps at the site of
injection). For the full list of all side effects reported with
Increlex(R), see the Summary of Product Characteristics.

Increlex(R) should not be used in people who may be hypersensitive
(allergic) to mecasermin or any of the other ingredients. It should
also not be used in patients who have, or are thought to have active
neoplasia (abnormal cell growth). Treatment with Increlex(R) should be
stopped if neoplasia develops. It should not be used in babies.

Marketing

Increlex(R) has been marketed in the United States by Tercica,
Inc. since early 2006.

Note to editors

The regulatory status of medications as referred to in these
materials may vary from country to country. Please refer to the local
product label and prescribing information.

About Ipsen

Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company's development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen's shares are
traded on Segment A of Eurolist by Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen' s shares are eligible to the "Systeme a
Reglement Differe" ("SRD") and the Group is part of the SBF 250 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. 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
Autorite des Marches Financiers.

About Tercica

Tercica is a biopharmaceutical company committed to improving
endocrine health by partnering with the endocrine community to develop
and commercialize new therapeutics for pediatric and adult growth
disorders, and for adult metabolic disorders. For further information
on Tercica, please visit www.tercica.com.