Ipsen Announces the Launch of Dysport® (abobotulinumtoxinA) in the United States for the Treatment of Cervical Dystonia

* Reuters is not responsible for the content in this press release.

Thu Oct 29, 2009 1:30am EDT

* Dysport® represents the first new botulinum toxin type A treatment option in
eight years to reach the U.S. market place

PARIS--(Business Wire)--
Regulatory News: 

Ipsen (Paris: IPN), an innovation-driven global specialty pharmaceutical group,
today announced that Dysport® is now available in the United States for the
treatment of cervical dystonia in adults. 

Dysport® is the latest addition to the growing range of Ipsen`s drugs already
available in North America, both in endocrinology with Somatuline® Depot and
Increlex®, and in neurology, with Apokyn®. 

Christophe Jean, Executive Vice President, Operations of the Ipsen Group said:
"The launch of Dysport® in its therapeutic indication for the treatment of
cervical dystonia in the United States is undoubtedly a significant milestone to
strengthen Ipsen's presence in North America. We are very pleased to be able to
offer physicians a new and important treatment option for their patients
suffering from cervical dystonia. Dysport®, together with Somatuline® and
Increlex®, becomes Ipsen`s third product to be available globally. With the
achievement of this key milestone, I wish to congratulate and thank the teams
that are making this launch a reality thanks to their hard work and dedication
reflective of an efficient organization."

About Dysport®(abobotulinumtoxinA) 

Dysport® (abobotulinumtoxinA) inhibits release of the neurotransmitter
acetylcholine from peripheral cholinergic nerve endings, which reduces muscular
spasm. The active ingredient in Dysport® is a botulinum toxin type A, which acts
at the level of the neuromuscular junction in the targeted muscle. Used in
patient care in the United Kingdom since 1991, Dysport® has marketing
authorizations in 75 countries (as of 31 December 2008) for multiple therapeutic
uses. Patient exposure is estimated to be above two million single treatment
cycles, representing more than 840,000 patient years of treatment. 

Dysport® was approved by the Food and Drug Administration on 29 April 2009 for
two separate indications, the treatment of cervical dystonia to reduce the
severity of abnormal head position and neck pain in both toxin-naïve and
previously treated patients, and the temporary improvement in the appearance of
moderate to severe glabellar lines in adults younger than 65 years of age. Ipsen
will market Dysport® in the United States for the therapeutic indication
(cervical dystonia), while Medicis already markets Dysport® in the U.S. for the
aesthetic indication (glabellar lines). 

To help streamline access to Dysport®, Ipsen has developed a comprehensive
reimbursement program that provides comprehensive access and support for U.S.
patients and healthcare providers. The program, called PACE (Patient Access,
Care and Education), offers a customer service call center (888-525-2423) to
assist people seeking information about Dysport®. 

Boxed Warning for All Botulinum Toxin Products

On 30 April 2009, the U.S. Food and Drug Administration announced that safety
label changes, including a boxed warning, and a Risk Evaluation and Mitigation
Strategy (REMS), are necessary for all botulinum toxin products. 

About the Risk Evaluation and Mitigation Strategy (REMS) for Dysport®

DYSPORT® is differentiated from other marketed botulinum toxin products with the
unique name abobotulinumtoxinA. 

Ipsen has implemented a REMS in order to ensure that the potential benefits of
treating cervical dystonia with Dysport® outweigh the potential risks of:

* Medication errors related to the lack of interchangeability of Dysport® Units
with those of toxins of other manufacturers; and 
* The potential for the occurrence of spread of toxin effect beyond the
injection site.

A key element of the Dysport® REMS is an FDA-approved patient Medication Guide,
which will be provided with each carton of Dysport®. The physician should
provide a copy of the Medication Guide to each patient and review the contents
with the patient. By promoting an informed discussion between the physician and
patient, the Medication Guide will help ensure that patients are fully aware of
and understand the risks of Dysport® treatment in relation to the potential
benefits. 

Important Safety Information About Dysport®

Dysport® should not be used in children or pregnant women. 

The effects of Dysport® and all botulinum toxin products may spread from the
area of injection to produce symptoms consistent with botulinum toxin effects.
These symptoms have been reported hours to weeks after injection. Swallowing and
breathing difficulties can be life threatening, and there have been reports of
death. The risk of symptoms is probably greatest in children treated for
spasticity, but symptoms can also occur in adults, particularly in those
patients who have underlying conditions that would predispose them to these
symptoms. Immediate medical attention may be required in cases of respiratory,
speech or swallowing difficulties. 

Dysport® is contraindicated in patients with hypersensitivity to any botulinum
toxin product or excipients, allergy to cow`s-milk protein, or infection at the
proposed injection site. 

The potency units of Dysport® are not interchangeable with other preparations of
botulinum toxin products and, therefore, units of biological activity of
Dysport® cannot be compared to or converted into units of any other botulinum
toxin products assessed with any other specific assay method. 

Dysport® should be administered in accordance with the labelling instructions,
and the recommended dosage and frequency of administration should not be
exceeded. 

Patients with a neuromuscular disorder of the nerve-muscle junction may be at
increased risk of side effects. 

Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.


Patients receiving concomitant treatment of Dysport® and aminoglycosides or
other agents interfering with neuromuscular transmission (e.g., curare-like
agents), or muscle relaxants, should be observed closely because the effect of
botulinum toxin may be potentiated. 

The most commonly reported adverse reactions (>5% of patients) observed with
Dysport® for the treatment of cervical dystonia are muscular weakness,
dysphagia, dysphonia, dry mouth, injection site discomfort or pain, fatigue,
headache, neck pain, musculoskeletal pain, and eye disorders. 

Visit www.Dysport.com to see the full Prescribing Information, including Boxed
Warning and Medication Guide, as well as the PACE program. 

About Cervical Dystonia

Cervical dystonia is an orphan condition in the U.S. affecting approximately
125,000 people.1 It is a chronic and painful condition characterized by neck
muscles contracting involuntarily, which causes abnormal movements and awkward
posture of the head and neck. Symptoms usually begin in people age 40 years or
older, and women are more commonly affected by the condition than men.2

About Ipsen

Ipsen is an innovation-driven global specialty pharmaceutical group with over 20
products on the market and a total worldwide staff of nearly 4,200. Its
development strategy is based on a combination of specialty medicine, which is
Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology,
neurology and haematology), 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
800 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 2008, Research and Development expenditure was about €183
million, close to 19% of consolidated sales, which amounted to €971 million
while total revenues exceeded €1 billion. Ipsen`s shares are traded on Segment A
of Euronext Paris (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. 

Ipsen Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are
based on the Group`s management strategy, 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 targets described in this document were
prepared without taking into account external growth assumptions and potential
future acquisitions, which may alter these parameters. These objectives are
based on data and assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and not
exclusively on historical data. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. Furthermore,
the Research and Development process involves several stages each of which
involve the substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to 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. The Group also depends on third parties to develop and market some of
its products which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the Group`s
activities and financial results. The Group 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. The Group`s business is subject to the
risk factors outlined in its registration documents filed with the French
Autorité des Marchés Financiers. 

1 Saunders-Pullman R et al. (2005) A new screening tool for cervical dystonia.
Neurology 64: 2046-2049 

2 Dystonia Medical Research Foundation: www.dystonia-foundation.org

For further information:
Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Financial Community
David Schilansky
Investor Relations and Financial Officer
Tel.: +33 (0)1 58 33 51 30
Fax: +33 (0)1 58 33 50 63
E-mail: david.schilansky@ipsen.com
or
Pierre Kemula
Investor Relations Manager
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com



Copyright Business Wire 2009

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