ONO Announces Transfer of the Manufacturing and Marketing Approval Authorization for Kinedak Tablets to Alfresa Pharma Corporation
Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; “ONO”) announced today that it has agreed to transfer the manufacturing and marketing approval authorization (MMAA) for Kinedak tablets which ONO has retained, as from April 1st, 2021 to Alfresa Pharma Corporation (Osaka, Japan; President, Koichi Shimada; “Alfresa Pharma”).
Kinedak tablets, for which the MMAA will be transferred this time, is a first-in-class ethical drug created by ONO and has been used for the treatment of many patients with diabetic peripheral neuropathy.
From now on, ONO and Alfresa Pharma will work together toward the transfer, to ensure a stable supply of Kinedak tablets and to contribute the activities for proper use of the product through the provision and collection of product information.
Product to be transferred:
| Product name | Therapeutic category |
|---|---|
| Kinedak® tablets 50 mg | Aldose reductase inhibitor |
1. Kinedak® tablets
| Product name | Kinedak® Tablets |
| Generic name | Epalrestat |
| Therapeutic category | Aldose reductase inhibitor |
| Content | 50 mg |
| Dosage form | Film-coated tablet |
| Indication | Improvement of subjective symptoms (numbness and pain), abnormality of vibration sense and abnormal changes in heart beat associated with diabetic peripheral neuropathy (in case of high levels of glycosylated hemoglobin) |
2. Outline of the relevant companies
2.1 Ono Pharmaceutical Co., Ltd. (As of September 30, 2020)
| 1 | Company | Ono Pharmaceutical Co., Ltd. |
| 2 | Location | 8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka |
| 3 | Representative | Gyo Sagara, President, Representative Director |
| 4 | Business operation | Research, development, manufacture, purchase and sales of various pharmaceutical products, mainly ethical drugs |
| 5 | Capital | JPY 17.358 billion |
| 6 | Founded | 1947 |
| 7 | Net assets | JPY 610.598 billion |
| 8 | Gross assets | JPY 706.795 billion |
2.2 Alfresa Pharma Corporation (As of September 30, 2020)
| 1 | Company | Alfresa Pharma Corporation |
| 2 | Location | 2-2-9 Kokumachi, Chuo-ku, Osaka |
| 3 | Representative | Koichi Shimada, President and CEO |
| 4 | Business operation | Manufacture, import, export and sales of pharmaceutical products, diagnostics, medical devices, raw materials for pharmaceutical products, etc. |
| 5 | Capital | JPY 3 billion |
| 6 | Founded | 1939 |
| 7 | Net assets | JPY 38.493 billion |
| 8 | Gross assets | JPY 51.971 billion |