Ipsen:AZZALURE(R) Approved in Germany for Aesthetic Use in the Treatment of Glabellar Lines

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

Fri Jun 26, 2009 2:00am EDT

* This market authorisation is part of a process including 15 countries in
Europe
* Azzalure(R) will be commercialised in Germany by Galderma

PARIS & LAUSANNE, Switzerland--(Business Wire)--
Regulatory News: 

Galderma, the leading pharmaceutical company in dermatology, and Ipsen
(Paris:IPN), an international innovation-driven specialty pharmaceutical group,
today announced that Azzalure® (botulinum toxin Type A manufactured by Ipsen), a
muscle relaxant specifically developed for aesthetic use, has received a
marketing authorization in Germany from the regulatory authorities
(Bundesinstitut für Arzneimittel und Medizinprodukte) for the temporary
improvement in the appearance of moderate to severe glabellar lines seen at the
frown (vertical lines between the eyebrows), in adult men and women aged 65
years and under, when the severity of these lines has an important psychological
impact on the patient. 

The approval was based on several clinical trials involving more than 2,600
patients, which confirmed the safety and efficacy of Azzalure®. Azzalure is
adapted from Dysport® (botulinum toxin type-A), which is already marketed by
Ipsen for a variety of indications and has a 20-year long history of product
consistency and safety. Azzalure® will come in a very easy to use customized
dosage that is specifically designed to better meet the patient and physician
need. 

This marketing authorisation for Azzalure® follows the collective green light
from 15 European countries` Health Authorities and is one of the several
licenses Galderma and Ipsen anticipate in Europe this year. Azzalure will be
commercially available in Germany by the beginning of the 3rd quarter 2009. 

"Azzalure®`s marketing authorisation is an important event forpatients who need
corrective and aesthetic procedures. Patients can look forward to benefiting
from Galderma`s years of experience in dermatology, and our commitment to
providing the highest standards of medical education and training to healthcare
professionals. Azzalure® is the latest product in our expanding range of
dermatology treatments and emphasizes our commitment to the future of
dermatology", said Marc Wannhoff, General Manager of Galderma Germany. 

The world Corrective and Aesthetic marketplace was estimated in 2008 to 5
billion euros by Medical Insight (report published last year). Its growth could
reach up to 10% in 2009. In Europe, the average annual growth expected between
2009 and 2012 is 13.2%, driven by dramatic rise in the popularity of easy to use
and non invasive treatments, such as botulinum toxin procedures, that already
represent 60% of specialist procedures in Europe. 

About the agreement
This announcement represents the latest developments in a partnership
established in 2007 between Galderma and Ipsen. Under the terms of this
agreement, Galderma has been granted by Ipsen exclusive rights to develop,
promote and distribute Azzalure®, a customized dosage of its botulinum toxin
type A product Dysport®, for aesthetic indications. This agreement includes the
European Union and certain territories of the Middle East and Eastern Europe. In
addition, Galderma has also been granted first rights of negotiation for
aesthetic indications in the rest of the world, excluding the United States,
Canada and Japan. Last December 2007 Ipsen and Galderma entered into another
partnership for the exclusive promotion and distribution of Ipsen`s botulinum
toxin type A product, for use in aesthetic medicine and dermatological
indications in Brazil, Argentina and Paraguay.
Galderma will pay up to €20 million to Ipsen upon the achievement of certain
milestones, including local market approvals and product launches in certain
territories. Ipsen will manufacture and supply Galderma`s finished product at a
fixed supply price. In addition, Galderma will pay royalties on net sales to
Ipsen. 

About Galderma
Galderma, created in 1981 as a joint venture between Nestlé and L`Oréal, is a
global leading pharmaceutical company dedicated to the research, development and
marketing of innovative therapeutic, corrective and aesthetic solutions for
dermatology patients. Galderma`s expertise covers a broad spectrum of skin, hair
and nail diseases, with a focus on acne, rosacea, psoriasis and
steroid-responsive dermatosis, onychomycosis, pigmentary disorders, skin cancer
and medical solutions for skin senescence. The Company is present in 65
countries with more than 2900 employees (including 1000 medical sales
representatives). In 2008, Galderma had global revenues of 854 million euros.
With a main research and development center in Sophia Antipolis, France,
Galderma has one of the largest R&D facilities devoted exclusively to
dermatology. Galderma`s major brands are: Differin® 
      (adapalene), the company`s first home-grown product indicated for topical
treatment of acne, Epiduo® (adapalene and benzoyl peroxide / acne),
Rozex®/MetroGel® 1% (metronidazole / rosacea), Oracea® (doxycycline / rosacea),
Clobex® (clobetasol propionate / psoriasis), Tri-Luma® (hydroquinone, tretinoin,
fluocinolone acetonide / pigmentary disorders), Loceryl® (amorolfine /
onychomycosis), Azzalure® 
      / Dysport® (botulinum toxin type A / glabellar lines) and Cetaphil®
(therapeutic skin care line). The Company`s international website is
www.galderma.com. 

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 4,200. Its
development strategy is based on a combination of specialty products, which are
growth drivers, in targeted therapeutic areas (oncology, endocrinology and
neurology), 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 statements
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, as announced
on June 5, 2008 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. 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 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. 





Galderma
Medical Consulting Group
Annette Theis
Tel: +49 (0) 211 51 60 45-150
E-mail: annette.theis@medical-consulting.de
or
Galderma Laboratorium GmbH
Claudia Malek, Produkt Manager
Galderma Laboratorium GmbH
Georg-Glock-Str. 8 • 40474 Düsseldorf
Tel: +49 (0) 211 58 601-4262
E-mail: claudia.malek@galderma.com
or
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 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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