Regulatory News:
Ipsen (Paris:IPN) today announced that the Food and Drug
Administration (FDA) has accepted the filing of its BLA for Dysport(R)
in the United States to treat patients with cervical dystonia. This
acceptance signifies the start of the review process of the dossier.
About Dysport
The active substance in Dysport(R) is a botulinum neurotoxin type
A complex, which acts at the level of the neuromuscular junction in
the targeted muscle. Dysport(R), Ipsen´s botulinum toxin type A, is a
neuromuscular blocking toxin which acts to block acetylcholine release
at motor nerve ends and reduces muscular spasm. It was initially
developed for the treatment of movement disorders such as cervical
dystonia (a chronic condition in which the neck is twisted or
deviated), blepharospasm (involuntary eye closure), hemifacial spasm
and various forms of muscle spasticity, including post-stroke arm
spasticity, spasticity of the lower limbs (calf) in adults and
children with cerebral palsy. Dysport(R) was originally launched in
the United Kingdom in 1991 and has marketing authorisations in over 70
countries.
The product is currently referred to as Reloxin(R) in the United
States aesthetic market and Dysport(R) for medical and aesthetic
markets outside the U.S.
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 "Service de
Reglement Differe" ("SRD") and the Group is part of the SBF 250 index.
From 24 December 2007, the Group will be part of the SBF120 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. Thus, in order to develop a product
which is viable from a commercial point of view, the Group must
demonstrate, by means of pre-clinical and human clinical trials, that
the molecules are effective and not dangerous to human beings.
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
Autorite des Marches Financiers.
