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Maruho Receives Manufacturing and Marketing Approval and Insurance Coverage for In Vitro Diagnostic "Derma Quick® VZV"

Osaka (Japan), September 1, 2017 - Maruho Co., Ltd ("Maruho", Head Office: Osaka, Japan, President and CEO: Koichi Takagi) announces today that inspections using the in vitro diagnostic approved for manufacturing and marketing on June 27, 2017, (varicella-zoster virus antigen kit), (Brand name: "DermaQuick® VZV"), hereinafter referred to as "the product", received insurance coverage on August 7, 2017. Maruho plans to launch the product in January 2018.

The product is the first varicella-zoster virus (hereinafter VZV) antigen kit in the world with immunochromatography as the principle measurement. From a sample of skin rash, or a swab of a sore/ulcer fluid, it is possible to detect VZV antigens rapidly in 5 to 10 minutes.

Maruho markets oral and topical therapeutic drugs for the treatment of herpes zoster (shingles). By expanding our business to cover the entire care cycle (prevention, examination/diagnosis, treatment, and after care), Maruho is working to meet a wide range of patient needs at every stage of care.


Insurance Coverage Profile

In Vitro Diagnostic Name Varicella-zoster virus antigen kit
Date of Insurance Coverage August 7, 2017
NHI Service Points Varicella virus antigen qualitative analysis (epithelial cells) 240 points
NHI Diagnosis Points Immunological examination diagnosis fee 144 points


Product Profile:

Brand Name DermaQuick® VZV
Nonproprietary Name Varicella-zoster virus antigen kit
Target Use Detection of varicella-zoster virus antigen in a sample of skin rash (blister/pustule) or a swab of a sore/ulcer fluid (including epithelial cells). (To be used mainly for diagnosis of varicella-zoster virus infection).
Manufacturer Maruho Co., Ltd.


About herpes zoster (shingles)
Herpes zoster (shingles) is a disease caused by reactivation of the chickenpox varicella-zoster virus in latently-infected nerve ganglia.
Prodromal symptoms include neuralgia-like pain and sensory abnormalities, followed by a rash outbreak in a striped band at the site of the pain. Symptoms in the skin include cutaneous lesions that begin with zonal erythema and papules at the site of pain. These are followed by vesicles, pustules, erosion, and ulcers, which lead to the development of crusts. The skin eventually heals as the crusts fall off in 2-3 weeks after the onset. In addition, the pain caused by postherpetic neuralgia sometimes remains long term even after the rash heals.

Maruho's Initiatives towards treatment for herpes zoster (shingles)
Maruho markets anti-herpes virus drugs "Famvir® Tablets 250 mg" and "Casal® Cream 3%" as drugs related to the treatment of herpes zoster. In addition, in July this year Maruho received manufacturing and marketing approval for the anti-herpes virus agent "Amenalief® Tablets 200 mg" for the treatment of herpes zoster.

About Immunochromatography
Immunochromatography is a biochemical test (immunoassay) that measures the presence of molecules using an antigen-antibody reaction. It is a simple method that can be assessed visually without the use of special measuring equipment. A positive or negative result can be assessed according to the presence or absence of a colored line.

About Maruho
Maruho Co., Ltd. has its headquarters in Osaka and leads Japan in research and development, manufacturing and commercialization of dermatological products. Founded in 1915, Maruho has 1,398 employees (as of the end of September 2016), and net sales were approximately 70.1 billion yen in its 2016 fiscal year. Pursuing its long-term corporate vision of "Excellence in Dermatology," Maruho is striving to improve the health and quality of life of people all over the world.
For more information, please visit https://www.maruho.co.jp/english/

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