Announced details
Treatment of head lice in patients for whom existing treatments are insufficiently effective
In a Phase III clinical trial in Japan, the treatment-success rate was higher in the product application group than in the vehicle application group, and the difference was statistically significant. No adverse reactions or serious adverse reactions presenting a development concern were observed. Specific figures: Not disclosed.
On 27 February 2019, Kaken Pharmaceutical Co., Ltd. entered into a license agreement with Arbor Pharmaceuticals, LLC. covering development and commercialization in Japan, obtaining exclusive development and marketing rights for the product in Japan. Development has been supported by a grant from the Center for Research and Development Support of New Drugs and Unapproved Drugs, a general incorporated association.
Arbor Pharmaceuticals, LLC. is a subsidiary of Azurity Pharmaceuticals, Inc. Azurity Pharmaceuticals, Inc. is an unlisted global pharmaceutical company with more than 50 medicines across 10 therapeutic areas, providing medicines in more than 50 countries. The Center for Research and Development Support of New Drugs and Unapproved Drugs, a general incorporated association, provided a development grant for this product. The Ministry of Health, Labour and Welfare has established the Review Committee on Unapproved and Off-Label Drugs of High Medical Need.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
125th Annual Meeting of the Japanese Dermatological Association (the trial results are scheduled to be presented)
| Item | Details |
|---|---|
| Names of Products / Services Covered | KAR (generic name: ivermectin 0.5%), Sklice® Lotion, 0.5% |
| Counterparty | Arbor Pharmaceuticals, LLC., Azurity Pharmaceuticals, Inc., Center for Research and Development Support of New Drugs and Unapproved Drugs, a general incorporated association, Ministry of Health, Labour and Welfare, Organizations including the Japanese Dermatological Association |
| Counterparty overview | Arbor Pharmaceuticals, LLC. is a subsidiary of Azurity Pharmaceuticals, Inc. Azurity Pharmaceuticals, Inc. is an unlisted global pharmaceutical company with more than 50 medicines across 10 therapeutic areas, providing medicines in more than 50 countries. The Center for Research and Development Support of New Drugs and Unapproved Drugs, a general incorporated association, provided a development grant for this product. The Ministry of Health, Labour and Welfare has established the Review Committee on Unapproved and Off-Label Drugs of High Medical Need. |
| Relationship with the Company | On 27 February 2019, Kaken Pharmaceutical Co., Ltd. entered into a license agreement with Arbor Pharmaceuticals, LLC. covering development and commercialization in Japan, obtaining exclusive development and marketing rights for the product in Japan. Development has been supported by a grant from the Center for Research and Development Support of New Drugs and Unapproved Drugs, a general incorporated association. |
| Contract Date | 27 February 2019 |
| Applicable area | Treatment of head lice in patients for whom existing treatments are insufficiently effective |
| Quantitative Effects | In a Phase III clinical trial in Japan, the treatment-success rate was higher in the product application group than in the vehicle application group, and the difference was statistically significant. No adverse reactions or serious adverse reactions presenting a development concern were observed. Specific figures: Not disclosed. |
| Source | 125th Annual Meeting of the Japanese Dermatological Association (the trial results are scheduled to be presented) |
Items this document does not state (10)
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 development company was publicly solicited for an unapproved drug with a high medical need. Treatment options are limited in Japan, and the product is intended to address the unmet medical need of patients for whom existing treatments are insufficiently effective.