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Other Disclosures4886ASKA Pharmaceutical Holdings Co.,Ltd.Pharmaceuticals

Notice Regarding the Results of a Japanese Phase 3 Clinical Trial of the Relugolix Combination Product (AKP022) in Patients with Uterine Fibroids

The domestic Phase 3 trial of the relugolix combination product (AKP-022) in patients with uterine fibroids met its primary endpoint. Asuka Pharmaceutical will proceed with preparations for a marketing approval application based on the results of the long-term administration trial.

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Announced details

Relugolix combination product (AKP-022; generic names: relugolix, estradiol, norethindrone acetate)
Applicable field (uses covered by this announcement)

Uterine fibroids; endometriosis

Contract Date27 September 2021 (uterine fibroids); 31 May 2024 (endometriosis)
What the company reported numerically
Quantitative Effects

Statistically significant improvement over placebo in the primary endpoint

Usage history

Relugolix monotherapy (レルミナ tablets) is widely used in clinical practice for the indications of uterine fibroids and endometriosis.

Relationship between the counterparty and the company
ASKA Pharmaceutical Holdings Co.,Ltd.4886
Relationship with the Company

Asuka Pharmaceutical in-licensed the product from Takeda Pharmaceutical Company Limited and entered into a license agreement granting it exclusive development and commercialization rights in Japan for uterine fibroids and endometriosis.

CounterpartyTakeda Pharmaceutical Company Limited

Head office: Chuo-ku, Osaka. Other details: not disclosed.

Location (as indicated in this announcement)

Asuka Pharmaceutical head office: Minato-ku, Tokyo. Takeda Pharmaceutical Company Limited head office: Chuo-ku, Osaka.

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Announced details
ItemDetails
Names of Products / Services CoveredRelugolix combination product (AKP-022; generic names: relugolix, estradiol, norethindrone acetate)
CounterpartyTakeda Pharmaceutical Company Limited
Counterparty overviewHead office: Chuo-ku, Osaka. Other details: not disclosed.
Relationship with the CompanyAsuka Pharmaceutical in-licensed the product from Takeda Pharmaceutical Company Limited and entered into a license agreement granting it exclusive development and commercialization rights in Japan for uterine fibroids and endometriosis.
Contract Date27 September 2021 (uterine fibroids); 31 May 2024 (endometriosis)
Applicable areaUterine fibroids; endometriosis
LocationAsuka Pharmaceutical head office: Minato-ku, Tokyo. Takeda Pharmaceutical Company Limited head office: Chuo-ku, Osaka.
Quantitative EffectsStatistically significant improvement over placebo in the primary endpoint
Usage historyRelugolix monotherapy (レルミナ tablets) is widely used in clinical practice for the indications of uterine fibroids and endometriosis.
Items this document does not state (9)
Contract ValueOffering priceLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleImpact on Business PerformanceSource

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 product is being developed to combine relugolix with an estrogen and a progestin, making long-term administration possible for the first time.

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Notice Regarding the Results of a Japanese Phase 3 Clinical Trial of the Relugolix Combination Product (AKP022) in Patients with Uterine Fibroids | ASKA Pharmaceutical Holdings Co.,Ltd. (4886) timely disclosure | Komori