Mirvaso® (brimonidine) the First and Only Treatment Targeting the Facial Redness of Rosacea Approved by the European Commission

Lausanne, Switzerland (ots/PRNewswire) -

- Galderma portfolio expands to offer a fast onset and long-acting
alpha-2

adrenergic receptor agonist -

Galderma, a leading global pharmaceutical company exclusively
focused on dermatology, today announced that the European Commission
has granted Marketing Authorisation in Europe for Mirvaso(R)
(brimonidine) 3 mg/g gel.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/65011-mirvaso-first-and-only-treatment-
rosacea

Mirvaso(R) is an alpha-2 adrenergic receptor agonist that acts
rapidly and can last for up to 12 hours.[1] It is indicated for the
symptomatic treatment of facial erythema (redness) of rosacea in
adult patients.

"Mirvaso(R)is the only approved medicinal product that directly
targets the facial redness of rosacea and provides an innovative
therapy for the condition. Applied once-daily, Mirvaso(R)works
quickly to reduce the redness of rosacea," said Humberto C. Antunes,
President and CEO of Galderma. "This is yet another milestone in
Galderma's continued R&D commitment to address the unmet needs of
patients with skin conditions."

The European Commission decision to grant Marketing Authorisation
in Europe for Mirvaso(R) is based on data collected from 553 patients
enrolled in two phase 3 clinical trials of one-month duration.[1] The
results from both studies showed that adults with rosacea erythema
who used Mirvaso(R) demonstrated significantly greater reduction of
the facial redness than the ones who applied vehicle gel only.[1] In
addition, a long-term study in 449 subjects who used Mirvaso(R) for
up to 12-months demonstrated that Mirvaso(R) was effective and well
tolerated.[2]

"Rosacea is a chronic, inflammatory and vascular disorder
affecting the face, with facial erythema (redness) being a prominent
characteristic. If left untreated the condition often has a severe
impact on patients' quality of life," said Dr Alison Layton (MB, ChB,
MRCP, FRCP) Consultant Dermatologist at Harrogate and District NHS
Foundation Trust in the United Kingdom. "Up until now there has been
no clinically approved treatment targeting the facial erythema of
rosacea and Mirvaso(R)can play a key role in the treatment of facial
redness. Mirvaso(R)offers patients an easy to apply, long acting
treatment with visible reductions in facial redness within 30 minutes
of application - potentially giving them a better quality of life."

Marketing Authorisation in Europe for Mirvaso(R) is applicable to
the 28 Member States of the European Union, as well as Iceland,
Lichtenstein and Norway.

For further information about the company, please visit
http://www.galderma.com and follow @galderma
[https://twitter.com/galderma ] on Twitter and LinkedIn
[http://www.linkedin.com/company/galderma ].

About Mirvaso(R) (brimonidine)

Mirvaso(R) (brimonidine) 3 mg/g gel is an alpha-2 adrenergic
agonist indicated for the symptomatic treatment of facial erythema of
rosacea in adult patients. Mirvaso(R) is the proprietary name
endorsed by the European Medicines Agency (EMA) for brimonidine.

Galderma - a global company exclusively dedicated to dermatology

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 33 wholly-owned
affiliates with a worldwide network of distributors and more than
5,000 employees. Galderma's extensive product portfolio is available
in 80 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 19% 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.
Five state-of-the-art R&D centers and five manufacturing sites are
dedicated to providing a wide range of innovative medical solutions
which meet the highest standards of safety and efficacy.

Strategic brands include Epiduo, Oracea, Clobex, Differin,
Mirvaso(R), Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl,
Cetaphil, Metvix, Azzalure, Restylane and Emervel.

References

1) Fowler J, Jackson M, Moore A et al. Efficacy and safety of once-daily
topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial
erythema of rosacea: results of two randomized, double-blind, vehicle-controlled
pivotal studies. J Drugs Dermatol 2013; 12 (6): 650-656.
2) Moore A, Kemper S, Murakawa G et al. Long-term safety and efficacy of
once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to
severe facial erythema of rosacea: results of a 1-year open-label study. J Drugs
Dermatol 2014; 13 (1): 56-61.

Video:
http://www.multivu.com/mnr/65011-mirvaso-first-and-only-treatment-rosacea

ots Originaltext: Galderma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Corporate Media Relations: Karin Falck, Public and Media
Relations Officer, Mobile: +41-797-226-075, E-mail:
karin.falck@galderma.com