AnGes : Notice on the NHI Drug Price Standard Listing and Launch Schedule of Zokinvy for the Treatment of Progeria
April 17, 2024 at 03:32 am EDT
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April 17, 2024
Company Name: AnGes Inc.
Presentative: Ei Yamada, President & CEO
Notice on the NHI Drug Price Standard Listing and Launch Schedule of Zokinvy
for the Treatment of Progeria
AnGes is pleased to announce that Zokinvy, a drug for the treatment of premature aging, which received approval for production and marketing by the Ministry of Health, Labour and Welfare in January 2024, was today included in the NHI Drug Price Standard.
Zokinvy, for the treatment of Hutchinson-Gilford-Progeria syndrome (HGPS) and processing- deficient progeroid laminopathies (PL) among other progeria, was approved and marketed in the United States in November 2020 and subsequently approved in the European Union and the United Kingdom. In May 2022, we obtained exclusive rights to market the product in Japan, and in March 2023, it was designated as an orphan drug by the Ministry of Health, Labour and Welfare (MHLW) and received manufacturing and marketing approval on January 18, 2024
With the drug's listing in the NHI drug price standard today, the Company will proceed with preparations for the launch of sales by May 2024.
In response to this listing in the NHI drug price standard, our president and representative director, Ei Yamada, commented as follows. "We are pleased that Zokinvy was included in the NHI drug price list today. We apologize for any concern this may cause to stakeholders due to the recently announced Chapter 11 filing in the U.S. by the manufacturer of this product, Eiger BioPharmaceuticals Inc. Based on the number of patients expected to use this product, we have already received the number of this product that is expected to be needed for the time being in Japan. We will continue to make preparations to deliver this drug as soon as possible to HGPS patients who have no effective treatment in Japan, as well as to patients with processing-deficient PL.
In addition, at Angels Clinical Research Laboratory (ACRL), the Company has established a system to perform genetic testing for HGPS and processing-deficient PL. This will allow us to provide support for the diagnosis and treatment of HGPS and dysprocessing PL."
Prouct Name
Unit
Price (Yen)
Zokinvy capsule 50mg
50mg
1capsule
91,796.40
Zokinvy capsule 75mg
75mg
1capsule
136,544.00
The packaging unit for Zokinvy Capsules 50 mg and Zokinvy Capsules 75 mg is a bottle containing 30 capsules, which is difficult to separate into smaller packages, and because a bottle cannot be used up in 14 days due to its dosage and administration, it was deemed "reasonable for the dosing period to exceed 14 days" and an exception to the 14-day prescription was granted. Therefore, it was deemed "reasonable for the medication period to exceed 14 days" and was approved to be an exception to the 14-day prescription.
(Note)This document has been translated from the Japanese original for reference purposes only.
In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.
Since the Company's earnings forecast for the current fiscal year anticipates sales of "Collategene" and "Zokinvy" together with testing fees for rare genetic diseases, there is no impact on the earnings forecast due to this matter.
(Note)This document has been translated from the Japanese original for reference purposes only.
In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.
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17 April 2024 and is solely responsible for the information contained therein. Distributed by
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AnGes, Inc., formerly AnGes MG, Inc., is a Japan-based company mainly engaged in the development of genetic medicines. The Company is involved in the development of hepatocyte growth factor (HGF) genetic medicines, NF-KB decoy oligo and hemagglutinating virus of Japan envelope (HVJ-E) non-viral vector, among others. As of December 31, 2012, the Company had four consolidated subsidiaries. On January 31, 2013, the Company sold a 95.3% stake of a Osaka-based subsidiary to ISHIHARA SANGYO KAISHA LTD.