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| [December 03, 2012] |
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Ipsen and Galderma increase their collaboration for Dysport® in new territories
PARIS & LAUSANNE, Switzerland --(Business Wire)--
Regulatory News:
Ipsen (Euronext: IPN, ADR: IPSEY), a global specialty-driven
pharmaceutical group, and Galderma, a leading global pharmaceutical
company focused on dermatology, today announced that their collaboration
for the promotion and distribution of Dysport®, Ipsen's
botulinum toxin type A in aesthetic indications, has been extended. Both
companies renewed their collaboration in Brazil and Argentina and
extended their partnership to Australia where Galderma has the exclusive
promotion and distribution rights for Ipsen's Dysport® in
glabellar lines indication. In those territories, Galderma has a unique
and complete portfolio of products and services in the Aesthetic &
Corrective field, with products such as Restylane®, Emervel®
and Pliaglis®. In Brazil, the world's second largest
aesthetic market, Dysport® sales within aesthetics doubled
over the initial agreement period (2008-2012).
Both companies also entered into a co-promotion agreement in South Korea
where Galderma and Ipsen will co-promote Dysport® and
Restylane®.
Marc de Garidel, Chairman and CEO of Ipsen, said: "Ipsen and
Galderma's combined commitment has been providing the highest standards
of medical education and training to healthcare professionals and new
therapeutic alternative and advancement to patients. The extension of
our collaboration to new territories demonstrates the quality of our
fruitful relationship to achieve this successful partnership for patient
care."
Humberto C. Antunes, President & Chief Executive Officer of Galderma,
confirmed that, "Galderma is delighted to pursue its partnership with
Ipsen to important markets in South America and Asia Pacific. The
efficacy and safety profile of Dysport® is a
major advantage for patients seeking to improve their appearance and
repair some of the damage caused by time. These new contracts are the
continuation of a very successful partnership. We are convinced
that, along with Restylane®, Dysport®
has become one of the leaders in the Aesthetic muscle relaxant market.
Our portfolio combined with the Alliance training platform for
physicians reinforces Galderma as the preferred partner of
Dermatologists, Plastic Surgeons and Aesthetic physicians."
About the agreements
In Brazil (where Ipsen will continue to promote Dysport®
within the neuromuscular disorder indications) and Argentina, the
renewed agreements, which will come into force in January 2013, are for
an additional five-year period. In Australia, the 5-year exclusive
distribution agreement came into force on May 1st, 2012 and
the co-promotion agreement came into force on November 23, 2012 in South
Korea.
Under the terms of the agreement signed with Ipsen in 2009, Ipsen
granted Galderma exclusive rights to develop, promote and distribute its
botulinum toxin type A product in the European Union and certain
territories of the Middle-East and Eastern Europe. In Europe, the
botulinum toxin type A product, specifically formulated for aesthetic
use, is branded under the trademark Azzalure® and is approved
for use in aesthetic indications (glabellar lines). Galderma is
currently marketing Azzalure® in 16 countries in Europe.
About Ipsen's botulinum toxin type A
Dysport®, 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®
was originally launched in the United Kingdom in 1991 and has marketing
authorisations in 75 countries (at 31 December 2011).
The product is currently referred to as Dysport® for medical
and aesthetic markets and as Azzalure® in aesthetic indication in EU. In
March 2006, Ipsen granted Medicis the rights to develop, distribute and
commercialize Ipsen's botulinum toxin type A product in the United
States and Canada for aesthetic use.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.1 billion in 2011. Ipsen's ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by four franchises:
neurology / Dysport®, endocrinology / Somatuline®,
uro-oncology / Decapeptyl® and hemophilia. Moreover, the
Group has an active policy of partnerships. R&D is focused on innovative
and differentiated technological patient-driven platforms, peptides and
toxins. In 2011, R&D expenditure totaled more than €250 million, above
21% of Group sales. The Group has total worldwide staff of close to
4,500 employees. Ipsen's shares are traded on segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the
"Service de Règlement Différé" ("SRD"). The Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary
Receipt (ADR) program, which trade on the over-the-counter market in the
United States under the symbol IPSEY. For more information on Ipsen,
visit www.ipsen.com.
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. All of the above risks
could affect the Group's future ability to achieve its financial
targets, which were set assuming reasonable macroeconomic conditions
based on the information available today.
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. Actual results may depart
significantly from these targets given the occurrence of certain risks
and uncertainties, notably the fact that a promising product in early
development phase or clinical trial may end up never being launched on
the market or reaching its commercial targets, notably for regulatory or
competition reasons. The Group must face or might face competition from
Generics that might translate into loose of market shares.
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 favorable 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.
About Galderma
Galderma is a global company founded in 1981 committed to delivering
innovative medical solutions to meet the dermatological needs of people
throughout their lifetime while serving healthcare professionals around
the world. The company has 31 wholly-owned affiliates with a worldwide
network of distributors and more than 4,000 employees. Galderma's
extensive product portfolio is available in 70 countries and treats a
range of dermatological conditions including: acne, rosacea,
onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary
disorders, skin cancer and medical solutions for skin senescence.
With approximately 20% of revenues invested each year to discover and
develop new products and access innovative technologies, the company is
one of the world's leading investors in dermatology R&D. Four
state-of-the-art R&D centers and four manufacturing sites are dedicated
to providing a wide range of innovative medical solutions which meet the
highest standards of safety and efficacy.
Strategic global brands include Epiduo, Oracea, Clobex, Differin,
Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Metvix,
Azzalure, Dysport*, Pliaglis, Restylane and Emervel.
*Dysport is a trademark of Ipsen
In 2011, to strengthen its presence in the aesthetic and corrective
dermatology market, Galderma acquired Q-Med, a Swedish medical device
company specialized in aesthetics. The company now offers a
comprehensive and synergizing portfolio of aesthetic and corrective
treatments, allowing physicians to better meet the needs of their
patients.

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