Regulatory News:
Ipsen (Paris:IPN) today announced that it has submitted a
Biologics License Application (BLA) for Dysport(R) for Injection in
cervical dystonia to the Food and Drug Administration (FDA) in the
United States for the treatment of patients with cervical dystonia. In
accordance with US regulations, the FDA will now be conducting a
technical screening of the application to ensure that sufficient data
and information have been submitted to justify the final review of the
dossier by the Center for Drug Evaluation and Research.
Dysport(R) has been granted orphan product status by the FDA as a
treatment for cervical dystonia, an orphan disease in the United
States. The BLA submission relies on data from two pivotal Phase III
studies performed in the United States and abroad totalling 252
patients followed-up for up to 12 treatment cycles, in addition to
substantial patient exposure in other clinical studies in cervical
dystonia.
Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen
stated: "The submission of the Dysport(R) BLA to the FDA is a further
sign of our strategic commitment to offer therapeutic responses for
the care of patients with targeted medical conditions such as cervical
dystonia. I am pleased that we were able to submit this application in
the planned timeframe. Further to Somatuline(R) Depot´s approval by
FDA in August, a new successful milestone has been achieved in Ipsen´s
international development strategy in specialised care."
About Dysport(R)
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.
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), is a neuromuscular blocking toxin, which acts to block
acetylcholine release, hence reducing muscular spasm was initially
developed for the treatment of motor disorders and various forms of
muscular spasticity, including cervical dystonia (a chronic condition
in which the neck is twisted or deviated), spasticity of the lower
limbs (heal) in children with cerebral palsy, blepharospasm
(involuntary eye closure) and hemifacial spasm. It was later developed
for the treatment of a wide variety of neuromuscular disorders and
aesthetic medicine.
Dysport(R) was originally launched in the United Kingdom in 1991.
At 31 December 2006, Dysport(R) had marketing authorisations in over
70 countries.
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.
