The adhesive base-ingredient technology of KM Transderm, a member of Kaneka Group, was adopted to a formulation containing a new base-ingredient for the treatment of Alzheimer’s Disease Dementia
June 27, 2019
A formulation containing a new base-ingredient*1 using adhesive technology of KM Transderm Ltd. (Headquarters: Kita-ku, Osaka; President: Haruki Tanabe; “KM Transderm”), affiliate company of Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Mamoru Kadokura; “Kaneka”), was approved on March 13, as a partial change in the approved items of the manufacturing and marketing approval*2.
This formulation adopted the technology of KM Transderm as a partial change to the transdermal formulation*3 for the treatment of Alzheimer’s Disease Dementia, sold as Rivastach® Patch and Exelon® Patch*4 (generic name: rivastigmine), marketed by Ono Pharmaeutical Co., Ltd. (Headquarters: Chuou-ku, Osaka; President: Gyo Sagara; “ONO”) and Novartis Pharma K.K. (Headquarters: Minato-ku, Tokyo; President: Kazunari Tsunaba; “Novartis Pharma”), in order to improve the current formulation.
With the original formulation containing a silicone ingredient, adverse drug reactions have been reported related to dermal symptoms at the patch application site such as redness and pruritus, etc. Therefore, ONO, Novartis Pharma and KM Transderm have been collaborating for development of a formulation containing a new base-ingredient. The unique adhesive technology of KM Transderm, which is adopted for this approved formulation containing new base-ingredient, provides a skin-friendly adhesive base with excellent touch and having appropriate adhesiveness without using a tackifier, which was conventionally necessary in the synthetic rubber base.
Kaneka Group will keep contributing to the improvement of patients’ QOL through the promotion of new product development in collaboration with pharmaceutical companies, utilizing our unique adhesive technologies.
- Base-ingredient is an ingredient which constitutes the fundamental part of a formulation other than the active pharmaceutical ingredient. In the transdermal formulation, this ingredient is used as the main ingredient in adhesive layer.
- A partial change in the approved items of the manufacturing and marketing approval is a supplemental approval by the authorities legally required when an approved drug product is to get any partial change in approved matters (Brand name, amount of active ingredient used, manufacturing method, raw materials, dosage and administration, specification, analytical method etc.). Pharmaceutical company applies in compliance with legal procedure and approved by authorities after the review and examination by specialized agencies.
- Transdermal formulation is a kind of drug formulation which is designed in order to deliver the active ingredient into whole body perfusion blood flow through the skin, and is applied to skin surface when used.
- Rivastach® Patch and Exelon® Patch are; Rivastigmine is an acetylcholinesterase inhibitor discovered by Novartis (Headquarters: located in Basel, Switzerland). In Japan, ONO and Novartis Pharma received the manufacturing and marketing approval for the products for suppression of the progression of symptoms associated with mild to moderate Alzheimer’s disease dementia in April 2011. ONO and Novartis Pharma launched the products under the product names of Rivastach® Patch and Exelon® Patch, respectively, in July 2011.Rivastigmine has been approved in more than 90 countries around the world as one of the standard therapies for mild to moderate Alzheimer’s disease dementia, starting with US in July 2007 and the EU in September 2007.
＜General description of KM Transderm Ltd.＞
Business: Research, development of transdermal medical products
President: Haruki Tanabe
Capital: 300 million JPY