Regulatory News:
Ipsen (Paris:IPN), an innovation-driven, international specialty
pharmaceutical group, and Galderma, a leading global pharmaceutical
company focused on dermatology, today announced that they have entered
into a new partnership for the exclusive promotion and distribution of
Ipsen´s Dysport(R), the company´s botulinum toxin type A product, for
use in aesthetic medicine and dermatological indications in Brazil,
Argentina and Paraguay.
Christophe Jean, Executive Vice President and Chief Operating
Officer of Ipsen, said, "We are very pleased to extend our existing
European partnership with Galderma for the promotion and
commercialisation of our botulinum toxin product to now include three
important markets in South America for aesthetic medicine indications.
This new agreement will allow us to accelerate the market penetration
of Dysport(R) through Galderma´s strong presence and benefit from
increased exposure to some of the leading markets in the world for
aesthetic applications of botulinum toxin."
Humberto C. Antunes, Chief Executive Officer of Galderma,
confirmed that, "Galderma is delighted to work with Ipsen to make
Dysport(R) the leading botulinum toxin A in dermatology. Galderma´s
worldwide renown for innovation in dermatology and its close
relationship with Brazilian and Argentine physicians will greatly
increase the product´s usage in those countries. The efficacy and
safety profile of Dysport(R) is a major advantage for patients seeking
to improve their appearance and repair some of the damage caused by
time."
The agreement, which will come into force in January 2008 in
Brazil and Argentina and later in Paraguay, once approved in aesthetic
medicine and dermatological indications, is for an initial five-year
term that can be extended for an additional five-year period once
Galderma achieves the agreed sales targets. Ipsen will manufacture and
supply Dysport(R) 500 units to Galderma at a supply price. In
consideration for the rights granted by Ipsen to Galderma under the
agreement, Galderma will pay Ipsen an undisclosed upfront milestone.
In neuromuscular disorder indications Ipsen will continue to promote
Dysport(R) 500 units in Brazil, Argentina and Paraguay.
Under the terms of a previous agreement announced on 26 February
2007, Ipsen granted Galderma exclusive rights to develop, promote and
distribute a specific formulation for aesthetic medicine indications
of its botulinum toxin type A product in the European Union, Russia
and certain territories of the Middle East and Eastern Europe under a
different brand name and vial size. In addition, Ipsen also granted
Galderma first rights of negotiation for such specific formulation of
its botulinum toxin type A product for aesthetic medicine indications
in the rest of the world, excluding the United States, Canada and
Japan, as well as rights for future formulations.
Ipsen´s Dysport(R) has shown a strong safety and efficacy profile
in a number of indications since it was first approved in 1991.
Furthermore, studies have demonstrated its high clinical effectiveness
in aesthetic medicine indications.
About Ipsen´s botulinum toxin type A
The product is currently referred to as Reloxin(R) in the U.S.
aesthetic market and Dysport(R) for medical and aesthetic markets
outside the U.S. In March 2006, Ipsen granted Medicis the rights to
develop, distribute and commercialize Ipsen´s botulinum toxin product
in the United States, Canada and Japan for aesthetic use.
As of October 2007, Ipsen´s botulinum toxin type A has been
approved for aesthetic medicine indications in 21 countries:
Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt,
Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand,
Philippines, Slovak Republic, Ukraine, Uruguay, Venezuela, Vietnam,
and Russia (in Russia, it is the first botulinum toxin type A approved
in this field). Ipsen is also pursuing regulatory approval for medical
indications for the product in certain additional key international
markets.
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
(at 31 December 2006).
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.
About Galderma
Galderma is a global pharmaceutical company specializing in the
research, development and marketing of therapeutic, corrective and
aesthetic solutions for dermatology patients and a leading player in
the worldwide dermatology market. Its expertise covers a broad
spectrum of skin, hair and nail diseases.
Created in 1981, Galderma is a joint venture between Nestle and
L´Oreal and employs more than 2,600 people. The company has
wholly-owned affiliates in thirty-two countries and a worldwide
network of exclusive sales agents. In 2006, the company had global
revenues of EUR 687 million.
To drive sustained growth, Galderma relies on a significant level
of investment in research and development. The new 19.300-sq. meter
state-of-the art R&D center in Sophia Antipolis, dedicated exclusively
to innovation in dermatology, was completed in late 2006. This center
positions Galderma as the world´s leading investor in dermatology R&D
and underpins its commitment to the future of dermatology.
Galderma´s strategy for continued growth is to invest in its key
brands and market them globally (in more than sixty-five countries).
Differin(R), the company´s first home-grown product indicated for
topical treatment of acne, and other major products for treating
rosacea, psoriasis and onychomycosis (fungal nail infections) are the
drivers of the portfolio.
Committed to the future of dermatology, Galderma´s ambition is to
be recognized as the most competent and successful innovation-based
company focused exclusively on meeting the needs of dermatology
patients and physicians. Galderma´s website is www.galderma.com.
