KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 67,500 shares
3. Total amount of shares acquired: 217,326,000 yen
4. Period of acquisition: Started on February 1, 2024 and ended on February 29, 2024 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of February 29, 2024)
1) Total number of shares acquired: 1,861,800 shares
2) Total amount of shares acquired: 5,827,380,100 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 130,200 shares
3. Total amount of shares acquired: 413,456,500 yen
4. Period of acquisition: Started on January 1, 2024 and ended on January 31, 2024 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of January 31, 2024)
1) Total number of shares acquired: 1,794,300 shares
2) Total amount of shares acquired: 5,610,054,100 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 80,600 shares
3. Total amount of shares acquired: 251,006,500 yen
4. Period of acquisition: Started on December 1, 2023 and ended on December 31, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of December 31, 2023)
1) Total number of shares acquired: 1,664,100 shares
2) Total amount of shares acquired: 5,196,597,600 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Japan; Representative Director and President: Katsuhito Inoue; "Maruishi") announced that KORSUVA® IV Injection Syringe for Dialysis 17.5μg, 25.0μg, and 35.0μg (generic name: difelikefalin acetate "KORSUVA®") for the treatment of pruritus in patients undergoing hemodialysis will launch in Japan on December 13, 2023.
KORSUVA® is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO: Christopher Posner; "Cara"). In April 2013, Maruishi acquired certain rights from Cara, and since March 2017, Maruishi and Kissei have been jointly developing KORSUVA® for the indication of uremic pruritus in Japan. On September 25, 2023, Maruishi obtained manufacturing and marketing authorization of KORSUVA® in Japan for the treatment of pruritus in patients undergoing hemodialysis. The product is manufactured by Maruishi and marketed by Kissei in Japan.
KORSUVA® is provided as a pre-filled syringe formulation to facilitate convenience in the medical environment. Through the supply of KORSUVA® Kissei and Maruishi strive to expand treatment options for uremic pruritus and to improve the QOL (Quality of Life) of patients undergoing hemodialysis.
《 Reference 》
Product Summary of KORSUVA® IV Injection Syringe for Dialysis
Brand Name |
KORSUVA® IV Injection Syringe 17.5μg KORSUVA® IV Injection Syringe 25.0μg KORSUVA® IV Injection Syringe 35.0μg |
||||||||||
Generic Name |
Difelikefalin acetate (JAN) |
||||||||||
Indications |
Improvement of pruritus in hemodialysis patients (limited to cases in which the effects of existing treatments are insufficient) |
||||||||||
Dosage and Administration |
Normally, inject difelikefalin with the below table dosage to adults into the venous side of the dialysis circuit during return transfusion at the end of dialysis three times a week.
|
||||||||||
Formulation |
Injection (syringe) |
||||||||||
NHI price |
KORSUVA® 17.5μg 2,971 JPY per syringe |
||||||||||
Manufacturing and Marketing Authorization Holder |
Maruishi Pharmaceutical Co., Ltd. |
||||||||||
Distributer |
Kissei Pharmaceutical Co., Ltd. |
||||||||||
Date of Marketing Approval in Japan |
September 25, 2023 |
||||||||||
Date of Drug Price Listing |
November 22, 2023 |
||||||||||
Date of Launch in Japan |
December 13, 2023 |
Product photo
About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in spite of the absence of obvious skin lesion, which occurs in many patients with end-stage renal disease undergoing hemodialysis.
It is reported that long-lasting and intense distressing itching in these patients make their QOL very low and have negative impacts on psychological and physical health such as poor sleep quality, depression, and an increased risk of death.
It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. KORSUVA® selectively activates kappa opioid receptor which is one of the subtypes of opioid receptors, and exerts its antipruritic action by acting on the kappa opioid receptor.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/.
About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/.
About Cara Therapeutics, Inc.
Cara Therapeutics (Nasdaq: CARA) is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
For more information, visit https://www.caratherapeutics.com/ and follow the company on X (Twitter), LinkedIn and Instagram.
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 1,268,900 shares
3. Total amount of shares acquired: 3,995,777,300 yen
4. Period of acquisition: Started on November 1, 2023 and ended on November 30, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange
1) Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2) Market purchases based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of November 30, 2023)
1) Total number of shares acquired: 1,583,500 shares
2) Total amount of shares acquired: 4,945,591,100 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
*1 Natural language processing; technology to process human language (natural language) on a computer and convert it into a form that can be analyzed and extracted by a computer.
《 Reference 》
About SciBite Ltd.
SciBite is a data-first software company headquartered in the U.K. The company's technology leads the industry in pioneering state-of-the-art machine learning and ontology*2 approaches to maximize the value and potential of linguistic data to provide critical answers to business problems. Supporting the world's leading research and development organizations, the company's technology is a key component in the development and execution of scientific data-driven strategies.
https://scibite.com/
*2 Ontology; a technology that organizes knowledge in a specific domain to facilitate the organization and computer processing of information.
With respect to the acquisition of treasury shares announced yesterday (November 6, 2023), KISSEI PHARMACEUTICAL CO., LTD. (the "Company") is announcing that it has executed the repurchases as follows.
1. Reason for the acquisition of the own shares
To execute a flexible capital policy in response to changes in the business environment, while improving capital efficiency and enhancing shareholder returns.
2. Details of the acquisition
1) Type of shares acquired: Common shares of the Company
2) Total number of shares acquired: 1,165,300 shares
3) Total acquisition cost: 3,682,348,000 yen
4) Date of the acquisition: November 7, 2023
5) Acquisition method: Repurchase through ToSTNeT-3 of the Tokyo Stock Exchange
3. Status of the acquisition (from May 10, 2023 to November 7, 2023)
1) Type of shares acquired: Common shares of the Company
2) Total number of shares acquired: 1,479,900 shares
3) Total acquisition cost: 4,632,161,800 yen
4) Acquisition period: From May 10, 2023 to November 7, 2023
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution of the Board of Directors meeting regarding acquisition of treasury shares (Published on November 6, 2023)
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 1,200,000 shares
(Percentage of total number of issued shares (excluding treasury shares) :2.62%)
3) Total acquisition cost: 3,792,000,000 yen (maximum)
4) Date of the acquisition: November 7, 2023
5) Acquisition method: Repurchase through ToSTNeT-3 of the Tokyo Stock Exchange
2. Details of the resolution of the Board of Directors meeting held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) :4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") hereby announces that its Board of Directors, at a meeting held today (November 6, 2023), decided on a specific method of acquisition of its own shares through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3) , which was resolved at the Board of Directors meeting held on May 8, 2023, pursuant to the provisions of Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act as follows.
1. Method of acquisition
The Company will entrust the acquisition of its treasury shares at the closing price (including the final special quote) of 3,160 yen as of this day (November 6, 2023) through ToSTNeT-3 of the Tokyo Stock Exchange at 8:45 a.m. as of November 7, 2023 (no change to other trading systems and the trading time shall be made). In addition, such purchase order shall be valid only at the trading time mentioned above.
2. Details of the acquisition
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 1,200,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 2.62%)
3) Total acquisition cost: 3,792,000,000 yen (maximum)
4) Announcement of the results of the acquisition: The acquisition results shall be announced after the close of trading at 8:45 a.m. as of November 7, 2023.
Notes:1. The number of shares to be acquired as above shall not be changed. In addition, the whole or a part of the acquisition of the Company's own shares may not be made according to the market conditions.
Notes:2. Acquisition of the Company's own shares shall be made to sell orders matching buy orders.
(Reference)
1. Details of the resolution of the Board of Directors meeting held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative total of treasury shares repurchased in accordance with the resolution of the Board of Directors meeting held on May 8, 2023 (as of November 6, 2023)
・Total number of shares acquired: 314,600 shares
・ Total amount of shares acquired: 949,813,800 yen
3. Number of Treasury shares as of October 31, 2023
・Total number of issued shares (excluding treasury shares): 45,800,913
・Treasury shares: 3,510,272
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Companies Act after applying the provisions of Article 165, Paragraph 3 of the same Act, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 0 shares
3. Total amount of shares acquired: 0 yen
4. Period of acquisition: Started on October 1, 2023 and ended on October 31, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of October 31, 2023)
1) Total number of shares acquired: 314,600 shares
2) Total amount of shares acquired: 949,813,800 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
Revisions to the Consolidated Financial Results Forecast Figures for the Six Months Ended September 30, 2023 (April 1, 2023 - September 30, 2023)
Net sales | Operating profit | Ordinary profit | Profit attributable to owners of parent | Basic earnings per share | |
Previously announced forecast (A) | Million yen 35,500 |
Million yen 900 |
Million yen 1,500 |
Million yen 4,800 |
Yen 104.09 |
Revised forecast (B) | 36,900 | 2,000 | 3,400 | 5,600 | 122.26 |
Change (B - A) | 1,400 | 1,100 | 1,900 | 800 | |
Change rate (%) | 3.9 | 122.2 | 126.7 | 16.7 | |
(Reference) Results for the corresponding six months of the previous fiscal year |
32,864 | (625) | 308 | 3,326 | 72.13 |
Reasons for the Revision
Net sales for the six months ended September 30, 2023 are expected to exceed the initial forecast due in part to the growth of domestic pharmaceuticals in the Pharmaceutical Business. Operating profit, ordinary profit, and profit attributable to owners of parent for the six months ended September 30, 2023 are expected to exceed the initial forecast due to increased net sales and the recording of gain on sale of securities, etc.
The financial results forecast for the full year is scheduled to be announced with the publication of the consolidated financial results for the six months ended September 30, 2023 (scheduled for November 6, 2023).
(Note)The above forecasts are based on information available to the Company as of the date of publication of this document and certain assumptions as of the date of publication of this document on uncertainties that may have an impact on future financial results. Actual results may differ greatly from these forecasts due to a variety of factors in the future.
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Representative Director and President: Katsuhito Inoue; "Maruishi") today announced that the results of the double-blind period of the phase III clinical study of KORSUVA® IV Injection (generic name: difelikefalin acetate, development code: MR13A9 "KORSUVA®"), which obtained manufacturing and marketing authorization in Japan on September 25, 20231 for the treatment of pruritus in patients undergoing hemodialysis, were published in NEJM Evidence2.
The phase III study (Study Name: MR13A9-5) was a placebo-controlled, double-blind, parallel-group comparison study conducted in 178 hemodialysis patients with pruritus. During the 6-week double-blind period, patients were administered KORSUVA® or placebo. The change from baseline in mean itch Numerical Rating Scale (NRS) score at week 4, which was the primary endpoint, in the placebo and KORSUVA® groups was -1.09 and -2.06, respectively. The difference between the groups demonstrated that the KORSUVA® group was superior to the placebo group (P<0.001). Furthermore, the incidence of treatment-related adverse events was 15% for the KORSUVA® group and 3% for the placebo group.
KORSUVA® is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO:Christopher Posner). The product will be manufactured by Maruishi and marketed by Kissei in Japan.
Kissei and Maruishi strive to expand treatment options for uremic pruritus to contribute to improving the QOL of patients undergoing hemodialysis.
1. News Release: September 25, 2023.
KORSUVA® IV Injection Syringe 17.5μg, 25.0μg and 35.0μg Granted Marketing Authorization Approval in Japan for Treatment of Pruritus in Patients Undergoing Hemodialysis.
2. Ichiei Narita, et al. Difelikefalin for Hemodialysis Patients with Pruritus in Japan.
NEJM Evidence. Published October 17, 2023. DOI: 10.1056/EVIDoa2300094
URL https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300094
《 Reference 》
About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in spite of the absence of obvious skin lesion, which occurs in many patients with end-stage renal disease undergoing hemodialysis.
It is reported that long-lasting and intense distressing itching in these patients make their QOL very low and have negative impacts on psychological and physical health such as poor sleep quality, depression, and an increased risk of death.
It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. Difelikefalin acetate selectively activates kappa opioid receptor which is one of the subtypes of opioid receptors, and is indicated to suppress pruritus.
About KORSUVA® IV Injection Syringe
KORSUVA® is indicated for the treatment of pruritus in hemodialysis patients (for use only when conventional treatments are not sufficiently effective). It is provided as a pre-filled syringe formulation to facilitate convenience in the medical environment.
In April 2013, Maruishi acquired certain rights from Cara, and since March 2017, Maruishi and Kissei have been jointly developing KORSUVA® for the indication of uremic pruritus in Japan. The manufacturing and marketing approval in Japan was obtained on September 25, 2023.
About NRS (Numerical Rating Scale) score for itch
The NRS score for itch is a score that evaluates with an integer from 0 to 10 where "no itch" is 0 and "the worst itch" is 10 for the most intense itching felt in the day.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/.
About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area, and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/.
About Cara Therapeutics, Inc.
Cara Therapeutics (Nasdaq: CARA) is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
For more information, visit https://www.caratherapeutics.com and follow the company on X(Twitter), LinkedIn and Instagram.
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Corporate Law after applying the provisions of Article 165, Item 3 of the Law, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 0 shares
3. Total amount of shares acquired: 0 yen
4. Period of acquisition: Started on September 1, 2023 and ended on September 30, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of September 30, 2023)
1) Total number of shares acquired: 314,600 shares
2) Total amount of shares acquired: 949,813,800 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Representative Director and President: Katsuhito Inoue; "Maruishi") today announced that Maruishi has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for KORSUVA® IV Injection Syringe 17.5μg, 25.0μg, and 35.0μg (generic name: difelikefalin acetate, development code: MR13A9 " KORSUVA®") for the treatment of pruritus in patients undergoing hemodialysis.
KORSUVA® is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO:Christopher Posner; "Cara") and is the first intravenous formulation product in the world approved for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in patients undergoing hemodialysis. It was approved by the U.S. Food and Drug Administration in August 2021 and by the European Commission in April 2022.
In April 2013, Maruishi acquired the rights for the development and commercialization for acute pain and uremic pruritus in Japan, and since March 2017, Maruishi and Kissei have been jointly developing KORSUVA® for the indication of uremic pruritus in Japan. After KORSUVA® achieved favorable results in the Phase III clinical trial in Japan1, a manufacturing and marketing approval application was submitted in September 20222. KORSUVA® will be manufactured by Maruishi and marketed by Kissei in Japan.
KORSUVA® is provided as a pre-filled syringe formulation to facilitate convenience in the medical environment. Kissei and Maruishi will prepare for the smooth launch of KORSUVA® to expand treatment options for uremic pruritus and to improve the QOL (Quality of Life) of patients undergoing hemodialysis.
1. News Release on January 7, 2022
Positive Topline Results from Japanese Phase III Clinical Study (double-blind period) of Difelikefalin (MR13A9) in Hemodialysis Patients with Pruritus
2. News Release on September 28, 2022
Difelikefalin New Drug Application Submitted in Japan for Treatment of Pruritus in Hemodialysis Patients
For more details, please visit https://www.kissei.co.jp/ or https://www.maruishi-pharm.co.jp/.
《 Reference 》
Product Summary of KORSUVA® IV Injection Syringe
Brand Name |
KORSUVA® IV Injection Syringe 17.5μg KORSUVA® IV Injection Syringe 25.0μg KORSUVA® IV Injection Syringe 35.0μg |
||||||||||
Generic Name |
Difelikefalin acetate |
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Indications |
Treatment of pruritus in hemodialysis patients (for use only when conventional treatments are not sufficiently effective) |
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Dosage and Administration |
The usual dosage for adults is administered as difelikefalin three times per week by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment, as shown in the table below.
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Formulation |
IV Injection Syringe |
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Manufacturing and Marketing Authorization Holder |
Maruishi Pharmaceutical Co., Ltd. |
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Distributer |
Kissei Pharmaceutical Co., Ltd. |
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Date of Marketing Approval in Japan |
September 25, 2023 |
About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in spite of the absence of obvious skin lesion, which occurs in many patients with end-stage renal disease undergoing hemodialysis.
It is reported that long-lasting and intense distressing itching in these patients make their QOL very low and have negative impacts on psychological and physical health such as poor sleep quality, depression, and an increased risk of death.
It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. Difelikefalin acetate selectively activates kappa opioid receptor which is one of the subtypes of opioid receptors, and is indicated to suppress pruritus.
About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/.
About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/.
About Cara Therapeutics, Inc.
Cara Therapeutics (Nasdaq: CARA) is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus.
For more information, visit https://www.caratherapeutics.com/ and follow the company on X (Twitter), LinkedIn and Instagram.
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Corporate Law after applying the provisions of Article 165, Item 3 of the Law, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 67,400 shares
3. Total amount of shares acquired: 231,968,000 yen
4. Period of acquisition: Started on August 1, 2023 and ended on August 31, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of August 31, 2023)
1) Total number of shares acquired: 314,600 shares
2) Total amount of shares acquired: 949,813,800 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |
KISSEI PHARMACEUTICAL CO., LTD. (the "Company") announces status of acquisition of its own shares pursuant to Article 156 of the Corporate Law after applying the provisions of Article 165, Item 3 of the Law, which was announced on May 8, 2023, as follows.
1. Type of shares acquired: Common shares of the Company
2. Total number of shares acquired: 54,800 shares
3. Total amount of shares acquired: 160,971,500 yen
4. Period of acquisition: Started on July 1, 2023 and ended on July 31, 2023 (based on contract date)
5. Acquisition method: Market purchases on the Tokyo Stock Exchange based on a discretionary trading contract regarding acquisition of own shares
(Reference)
1. Details of the resolution at the meeting of Board of Directors held on May 8, 2023
1) Type of shares to be acquired: Common shares of the Company
2) Total number of shares to be acquired: Up to 2,000,000 shares
(Percentage of total number of issued shares (excluding treasury shares) : 4.34%)
3) Total acquisition cost: 6 billion yen (maximum)
4) Acquisition period: From May 10, 2023 to March 29, 2024
5) Acquisition method: Market purchases on the Tokyo Stock Exchange
1.Purchases through the Tokyo Stock Exchange Trading Network Off-Auction Own Share Repurchase Trading System (ToSTNeT-3)
2.Market purchases based on a discretionary trading contract regarding acquisition of own shares
2. Cumulative number and value of own shares acquired so far based on the above resolution at the Board of Directors meeting (As of July 31, 2023)
1) Total number of shares acquired: 247,200 shares
2) Total amount of shares acquired: 717,845,800 yen
Disclaimer: This document is an English translation of the original document in Japanese and has been prepared solely for reference purposes. In the event of any discrepancy between this English translation and the original in Japanese, the original shall prevail in all respects. |