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Other Disclosures4534Mochida Pharmaceutical Co.,Ltd.Pharmaceuticals

Notice of the submission in Japan of a marketing authorization application for MD-712 (inhaled powder), a treatment for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease

持田製薬 submitted an application to the Ministry of Health, Labour and Welfare for marketing approval in Japan of MD-712 (inhaled powder formulation), a treatment for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Once approved, it is expected to become a new treatment option alongside the existing injectable and inhaled solution formulations.

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Announced details

MD-712 (inhaled powder formulation)TYVASO DPI®Treprost® injectionTreprost® inhalation solution
Applicable field (uses covered by this announcement)
Pulmonary arterial hypertensionPulmonary hypertension associated with interstitial lung disease
Launch dateLaunch date in Japan: Not disclosed. In the United States, it has been marketed as TYVASO DPI® since 2022.
Relationship between the counterparty and the company
Mochida Pharmaceutical Co.,Ltd.4534
Relationship with the Company

Under an agreement with United Therapeutics Corporation, 持田製薬 markets treprostinil formulations in Japan.

CounterpartyUnited Therapeutics Corporation

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

Announced details
ItemDetails
Names of Products / Services CoveredMD-712 (inhaled powder formulation), TYVASO DPI®, Treprost® injection, Treprost® inhalation solution
CounterpartyUnited Therapeutics Corporation
Relationship with the CompanyUnder an agreement with United Therapeutics Corporation, 持田製薬 markets treprostinil formulations in Japan.
Launch dateLaunch date in Japan: Not disclosed. In the United States, it has been marketed as TYVASO DPI® since 2022.
Applicable areaPulmonary arterial hypertension, Pulmonary hypertension associated with interstitial lung disease
Items this document does not state (13)
Counterparty overviewContract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative EffectsUsage historyImpact on Business PerformanceSource

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The reasons the company gives

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

To further expand treatment options for pulmonary hypertension and contribute to improving patients' quality of life.

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Notice of the submission in Japan of a marketing authorization application for MD-712 (inhaled powder), a treatment for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease | Mochida Pharmaceutical Co.,Ltd. (4534) timely disclosure | Komori