Navigation Links
Galderma announces approval for Differin gel 0.1 percent in Japan
Date:7/17/2008

Lausanne, Switzerland July 16, 2008 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® 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® 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. 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 demonstrated that treatment with Differin® 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. A 12-month long-term safety study of more than 400 patients showed that the treatment was safe and remained effective with long-term use.

"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® 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® Gel 0.1% is a naphthoic acid derivative with retinoid-like activities. Differin® will be the first product to be launched in Japan belonging to this class of treatment. Differin® appears to normalize the differentiation of a type of skin cell linked to acne, resulting in fewer non-inflammatory and inflammatory lesions.


'/>"/>

Contact: Dale Weiss
dale.weiss@galderma.com
817-961-5186
WeissComm Partners
Source:Eurekalert

Related medicine news :

1. Galderma Completes Tender Offer for CollaGenex
2. Galderma Announces HSR Clearance for Its Proposal to Acquire CollaGenex Pharmaceuticals
3. ZARS Pharma Announces Worldwide License Agreement With Galderma Pharma S.A. for Pliaglis(TM), a Topical Local Anesthetic
4. Galderma Pharma, S.A. and ZARS Pharma, Inc. Extend Agreement to Cover Worldwide Rights for Pliaglis(TM)
5. Galderma Reaches Agreement to Acquire CollaGenex Pharmaceuticals
6. Galderma Associates Itself to Cartiers Womens Initiative Awards to Recognize Female Entrepreneurs From Around the Globe
7. Fresh Harvest Products, Inc. Announces New Brand Initiative
8. AMN Healthcare Announces Joint Commission Re-Certification
9. Peptimmune Announces the Second Close of Series D Private Financing
10. Immunosyn Announces Proposed Agreements for Distribution of the Biopharmaceutical SF-1019 in Utah
11. Webcast Alert: Genomma Lab Internacional, S.A.B. de C.V. announces Second Quarter 2008 Results Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance ... care insurance companies have a waiver for care if the client has a cognitive ... the family pays for care, is often waived, so the benefits from their insurance ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian history ... The Brink” is the creation of published author, William Nowers. Captain Nowers and ... WWII veteran, he spent thirty years in the Navy. Following his career as ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... drug delivery system that we intend to develop to enable prevention of a ... lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss ...
Breaking Medicine News(10 mins):
(Date:10/7/2017)... --  Provista, a proven leader in the supply ... power, today announced a new resource area on Provistaco.com ... is the online home for case studies, articles on ... releases, slideshows and events. ... at their fingertips, viewers can also watch short videos ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... announces the European launch of their new low volume, high throughput ... Cambridge, U.K on October 4th. The new ... unprecedented speed and sensitivity while using far less sample volume through ... ... ...
Breaking Medicine Technology: