Komori
Other Disclosures4507Shionogi & Co.,Ltd.Pharmaceuticals

Obtaining marketing authorization in Japan for an additional dosage and administration of VTAMA Cream for atopic dermatitis in children under 12

An additional dosage and administration for VTAMA Cream 0.5% for pediatric atopic dermatitis in children aged 2 to under 12 has been approved in Japan. This enables the product to be offered as a treatment option for pediatric patients.

Worth reading
73In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
—
Displayed only when the document provides numerical figures.
Wording
Definitive
How definitive the wording is.

Announced details

VTAMA® Cream 0.5%VTAMA® Cream 1%
Applicable field (uses covered by this announcement)

Pediatric atopic dermatitis in children aged 2 to under 12, atopic dermatitis in adults and children aged 12 and over, and plaque psoriasis in adults

Contract Date2020 (domestic exclusive development and commercialization rights agreement between JAPAN TOBACCO INC. and Dermavant Sciences GmbH)
What the company reported numerically
Quantitative Effects

Superiority to the vehicle cream was demonstrated on the primary endpoint after once-daily treatment for 8 weeks. Safety was evaluated after treatment for up to 60 weeks, confirming favorable tolerability.

Relationship between the counterparty and the company
Shionogi & Co.,Ltd.4507
Relationship with the Company

鳥居薬品株式会社 is a SHIONOGI group company. SHIONOGI & CO., LTD. is the marketing authorization holder and 鳥居薬品株式会社 is the distributor, with the two companies conducting domestic co-promotion. JAPAN TOBACCO INC. and 鳥居薬品株式会社 have entered into a domestic joint development and marketing agreement. JAPAN TOBACCO INC. transferred its pharmaceutical business to SHIONOGI & CO., LTD.

Counterparty鳥居薬品株式会社JAPAN TOBACCO INC.Dermavant Sciences GmbHOrganon & Co.

鳥居薬品株式会社 is headquartered in Chuo-ku, Tokyo, and its Representative Director and President is Kondo Shinya (近藤紳雅). The company has contractual relationships with JAPAN TOBACCO INC. and Dermavant Sciences GmbH. Other details are not disclosed.

Location (as indicated in this announcement)

SHIONOGI & CO., LTD.: Kita-ku, Osaka; 鳥居薬品株式会社: Chuo-ku, Tokyo

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 will be minor.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

jRCT (Clinical Research and Other Studies Submission and Disclosure System), jRCT2031230139; JAPAN TOBACCO INC. press release (24 June 2024)

Announced details
ItemDetails
Names of Products / Services CoveredVTAMA® Cream 0.5%, VTAMA® Cream 1%
Counterparty鳥居薬品株式会社, JAPAN TOBACCO INC., Dermavant Sciences GmbH, Organon & Co.
Counterparty overview鳥居薬品株式会社 is headquartered in Chuo-ku, Tokyo, and its Representative Director and President is Kondo Shinya (近藤紳雅). The company has contractual relationships with JAPAN TOBACCO INC. and Dermavant Sciences GmbH. Other details are not disclosed.
Relationship with the Company鳥居薬品株式会社 is a SHIONOGI group company. SHIONOGI & CO., LTD. is the marketing authorization holder and 鳥居薬品株式会社 is the distributor, with the two companies conducting domestic co-promotion. JAPAN TOBACCO INC. and 鳥居薬品株式会社 have entered into a domestic joint development and marketing agreement. JAPAN TOBACCO INC. transferred its pharmaceutical business to SHIONOGI & CO., LTD.
Contract Date2020 (domestic exclusive development and commercialization rights agreement between JAPAN TOBACCO INC. and Dermavant Sciences GmbH)
Applicable areaPediatric atopic dermatitis in children aged 2 to under 12, atopic dermatitis in adults and children aged 12 and over, and plaque psoriasis in adults
LocationSHIONOGI & CO., LTD.: Kita-ku, Osaka; 鳥居薬品株式会社: Chuo-ku, Tokyo
Quantitative EffectsSuperiority to the vehicle cream was demonstrated on the primary endpoint after once-daily treatment for 8 weeks. Safety was evaluated after treatment for up to 60 weeks, confirming favorable tolerability.
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 will be minor.
SourcejRCT (Clinical Research and Other Studies Submission and Disclosure System), jRCT2031230139; JAPAN TOBACCO INC. press release (24 June 2024)
Items this document does not state (8)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleUsage history

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The domestic Phase 3 clinical trial demonstrated superiority to the vehicle cream on the primary endpoint after 8 weeks of treatment, as well as favorable tolerability after treatment for up to 60 weeks.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Obtaining marketing authorization in Japan for an additional dosage and administration of VTAMA Cream for atopic dermatitis in children under 12 | Shionogi & Co.,Ltd. (4507) timely disclosure | Komori