Announced details
Treatment of pediatric overactive bladder (OAB). Treatment of overactive bladder in adults.
Efficacy and safety will be evaluated following 8 weeks of treatment.
杏林製薬 acquired exclusive development, manufacturing and marketing rights in Japan and Asia from Merck & Co., Inc. 杏林製薬 entered into a joint development and joint marketing agreement with KISSEI PHARMACEUTICAL CO.,LTD., and the two companies jointly develop and market the product.
Merck & Co., Inc., Rahway, N.J., U.S.A. is the U.S. company that originated vibegron. The registered address, representative, capital, year of establishment and business description of KISSEI PHARMACEUTICAL CO.,LTD. are not provided in this document.
The impact on the consolidated earnings forecast for the fiscal year ending March 2027 is expected to be immaterial.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Vibegron, Beova Tablets 50 mg |
| Counterparty | Merck & Co., Inc., Rahway, N.J., U.S.A., KISSEI PHARMACEUTICAL CO.,LTD. |
| Counterparty overview | Merck & Co., Inc., Rahway, N.J., U.S.A. is the U.S. company that originated vibegron. The registered address, representative, capital, year of establishment and business description of KISSEI PHARMACEUTICAL CO.,LTD. are not provided in this document. |
| Relationship with the Company | 杏林製薬 acquired exclusive development, manufacturing and marketing rights in Japan and Asia from Merck & Co., Inc. 杏林製薬 entered into a joint development and joint marketing agreement with KISSEI PHARMACEUTICAL CO.,LTD., and the two companies jointly develop and market the product. |
| Contract Date | Joint development and joint marketing agreement with KISSEI PHARMACEUTICAL CO.,LTD.: March 2016. Acquisition of exclusive rights from Merck & Co., Inc.: Japan, July 2014; Asia, April 2017. |
| Launch date | Phase 3 clinical trial: scheduled to begin; no specific start date is provided. Joint marketing of Beova Tablets 50 mg: conducted since November 2018. |
| Applicable area | Treatment of pediatric overactive bladder (OAB). Treatment of overactive bladder in adults. |
| Quantitative Effects | Efficacy and safety will be evaluated following 8 weeks of treatment. |
| Impact on Business Performance | The impact on the consolidated earnings forecast for the fiscal year ending March 2027 is expected to be immaterial. |
Items this document does not state (9)
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 aim is to expand the indication of Beova Tablets 50 mg to pediatric patients and provide a new treatment option, as no drugs are currently available in Japan for use in children with overactive bladder.