Based on the Largest Ever Clinical Program for Acne in Japan
LAUSANNE, Switzerland, July 16 /CNW/ -- Galderma Pharma S.A., a global
specialty pharmaceutical company focused on dermatology, announced today that
Japan's Ministry of Health, Labor and Welfare has approved Differin(R) Gel
0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The
drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of
Galderma, and strategic alliance partner Shionogi.
Differin(R) has been available for over 15 years and is currently
marketed in more than 80 countries, where it has become an important therapy
for more than 22 million patients.(1) Approval in Japan will reinforce
Galderma's presence in the world's second-largest pharmaceutical market.
Approval was based on non-clinical and clinical studies, which supported the
efficacy and safety of the product for the registration outside Japan and on
an extensive local clinical development program, including two phase 3 studies
enrolling more than 600 Japanese patients.
A 12-week study of the treatment in 200 Japanese patients(2a) a
demonstrated that treatment with Differin(R) Gel 0.1% led to a significant
reduction in both inflammatory and non-inflammatory lesions, as compared with
vehicle treatment, with some patients feeling the benefit after only one week
of treatment.(2b) A 12-month long-term safety study of more than 400
patients(3) a showed that the treatment was safe and remained effective with
"The collective results of three recent adapalene studies provide a
substantial evidence base for the safe and effective use of adapalene gel 0.1%
in Japanese patients with acne," said Clinical Trial Lead Investigator Makoto
Kawashima, MD, PhD Department of Dermatology Tokyo Women's Medical University.
"The availability of a topical retinoid in Japan will provide greater
flexibility for customizing care and improving outcomes for acne patients."
According to the agreement between both firms, Galderma and Shionogi will
co-promote Differin(R) Gel 0.1% with their respective sales forces and
Shionogi will have sales and distribution rights for the product for a period
of eight years. Commercialization will begin once the product is listed on the
National Health Insurance reimbursement list, a process that is expected to be
complete by autumn 2008.
"The decision by Japan's Ministry of Health, Labor and Welfare is
excellent news for patients and physicians in Japan, who will now have access
to a first-in-class topical retinoid for the treatment of acne," said Humberto
C. Antunes, Chief Executive Officer of Galderma International. "We undertook
the largest acne clinical program ever in Japan, and knew it would be a long
journey to approval. This project underscores Galderma's commitment to
dermatology in all parts of the world and dedication to improving the quality
of life of acne patients in Japan."
Differin(R) Gel 0.1% is a naphthoic acid derivative with retinoid-like
activities.2c Differin(R) will be the first product to be launched in Japan
belonging to this class of treatment. Differin(R) appears to normalize the
differentiation of a type of skin cell linked to acne, resulting in fewer
non-inflammatory and inflammatory lesions.2c
Acne vulgaris is one of the most widely experienced chronic skin diseases
worldwide. In recent years, research has led to a greater understanding of
the pathogenesis of the disease.(4) The disorder begins with the onset of
puberty and is thought to result from hormonal action on the skin's oil glands
(sebaceous glands) leading to plugged pores and outbreaks of spots.(5) It can
be challenging to manage, due to the variability in response to treatment. 2d
About Galderma Japan
Galderma KK, the fully-owned Japanese arm of Galderma, was established in
1996. It has been marketing the topical anti-fungal product Pekiron(R) Cream
0.5% (Loceryl(R)) under a licensing agreement with Kyorin Pharmaceutical since
2002. With the introduction of Differin(R) Gel 0.1% in Japan, Galderma KK,
aims to provide comprehensive scientific information to prescribers and
medical institutions, with the goal of improving treatment outcomes, as well
as the quality of life of Japanese acne patients.
Galderma, created in 1981 as a joint venture between Nestle and L'Oreal,
is a fully integrated specialty pharmaceutical company dedicated exclusively
to the field of dermatology. The Company is present in 65 countries with over
1000 medical sales representatives and is committed to improving the health of
skin with an extensive line of products to treat a range of dermatological
conditions including: acne, rosacea, fungal nail infections, psoriasis &
steroid-responsive dermatoses, pigmentary disorders, skin cancers and medical
solutions for skin senescence. With a main research and development center in
Sophia Antipolis, France, Galderma has one of the largest R&D facilities
devoted exclusively to dermatology. Leading dermatology brands include
Differin(R), MetroGel(R) 1%/Rozex(R), Oracea(R), Clobex(R), Tri-Luma(R),
Loceryl(R) and Cetaphil(R). Recently launched products include Pliaglis(R), a
topical anesthetic for dermatologic procedures in the United States,
Epiduo(R), an innovative combination product for the treatment of acne in
Europe and Argentina, and Dysport(R), an injectable muscle relaxant for use in
aesthetic medicine and dermatological indications in Brazil and Argentina. The
Company's international Web site is http://www.galderma.com.
Differin, MetroGel, Oracea, Rozex, Clobex, Tri-Luma, Loceryl, Cetaphil
and Epiduo are trademarks of Galderma.
Pliaglis is a trademark of Zars Pharma Inc.
Dysport is a trademark of Ipsen Ltd.
(1) Data on file.
(2) Kawashima M, Harada S, Loesche C and Miyachi Y. Adapalene gel 0.1% is
effective and safe for Japanese patients with acne vulgaris: A
randomized, multicenter, investigator-blinded, controlled study.
Journal of Dermatological Science. 2008; 49:241-248.
(3) Kawashima M, Harada S, Andres P and Miyachi Y. One-Year Efficacy and
Safety of Adapalene Gel 0.1% gel in Japanese Patients with Acne
Vulgaris. Skin Research. 2007; 6:504-512.
(4) Gollnick H, Cunliffe WJ, Berson D et al. Management of Acne: A Report
From a Global Alliance to Improve Outcomes in Acne. J Am Acad
Dermatol. 2003; 49(1):S1-S37.
(5) Why Do I Get Acne? Nemours Foundation.
For further information:
For further information: Worldwide Inquiries, Alain Kirsch, +33 (0) 1 58
86 43 23, firstname.lastname@example.org; or U.S. Inquiries, Dale Weiss,
+1-817-961-5186, email@example.com, both of Galderma Pharma S.A. Web