Telmisartan

April 08, 2025 -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that it has received a notice of allowance from the European Patent Office (EPO) for patent application 19827430.0 for its lead chronic kidney disease (CKD) program drug NP-251 (Repirinast). The invention claims the use of Repirinast, either alone or in combination with telmisartan, for the treatment or prophylaxis of renal fibrosis or kidney disease. The base claims of the patent will be valid through 2038, excluding any patent term adjustments or extensions which may provide additional protection. The Company has previously announced the allowance of this patent application in the U.S., Japan and China. The patent is currently pending in Canada. Repirinast is the Company’s lead candidate for the treatment of CKD based on data showing it reduced fibrosis by 51% with statistical significance and showed an additive benefit to telmisartan in a unilateral ureteral obstruction (UUO) mouse model. Algernon’s intellectual property strategy for its repurposed drug program includes protecting its compounds by filing patent applications including method of use, dosing, and formulations, and for new composition of matter patents based on novel salt forms. “This is our first patent issued by the EPO and marks another key milestone for the Company,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. The Company also announces a grant of 50,000 restricted share units (each, an "RSU") and 50,000 stock options to consultants of the Company. Each RSU entitles the recipient to receive one common share of the Company or a cash payment equal to the equivalent of one common share of the Company on vesting. The stock options are exercisable at $0.09 for five years from the date of grant. Both the RSUs and stock options vest on the date of grant. The RSUs and stock options are subject to approval by regulatory authorities. Repirinast was originally developed by Mitsubishi Tanabe Pharma (“Mitsubishi”) and was sold and marketed in Japan under the brand name RometTM for the treatment of Asthma. RometTM was marketed for over 25 years in Japan. Mitsubishi discontinued manufacturing and sales of the drug in 2013. Accordingly, Algernon has retained Zhejiang Ausun Pharmaceutical in Zhejiang, China to manufacture a cGMP Repirinast supply. Mast cells are recruited to sites of cellular damage, and degranulation of mast cells leads to release of a myriad of proinflammatory chemical mediators which lead to tissue damage in a self-propagating cascade. NP-251 binds to receptors on mast cells and prevents their degranulation, which the Company believes could help prevent fibrosis in multiple organ classes including the kidneys. Algernon Pharmaceuticals is a Canadian clinical stage drug development company investigating multiple drugs for unmet global medical needs. Algernon Pharmaceuticals is also the parent company of a private subsidiary called Algernon NeuroScience, that is advancing a psychedelic program investigating a proprietary form of DMT for stroke and traumatic brain injury. The content above comes from the network. if any infringement, please contact us to modify.

New Delhi: During its monthly quality review, the drug regulatory body identified 103 drug samples as ‘Not of Standard Quality’ ( NSQ ) and flagged a sample of the popular brand Telma H as ‘spurious.’ Of the 103 drug samples that failed to meet the quality standards, 47 were identified by central drug laboratories, while the remaining 56 were identified by state drug laboratories in the country. The drug sample that has been labeled as “spurious” is Telma H (Telmisartan 40mg & Hydrochlorothiazide 12.5mg), a popular brand prescribed for high blood pressure patients. As per the Union Health Ministry note, the sample was picked from West Bengal. As per the February drug alert issued by the Central Drugs Standard Control Organisation (CDSCO), the sample was manufactured in 2022 and the reason for the drug test failure as notified in the alert suggests that the sample “does not conform to I.P.” (Indian Pharmacopoeia). The branded generic drug is marketed by Glenmark and, as per an analysis from market research firm Pharmarack, it features among the top 50 brands in the country, with a moving annual total (MAT) value of around ₹447 crore. Regarding the identified spurious drug sample, the Health Ministry, in its quality review announcement, stated that the sample is “made by an unauthorized manufacturer using a brand name owned by another company. The matter is under investigation and action.” CDSCO, in its drug quality alert, has remarked that the product is purported to be spurious; however, the same is subject to the outcome of the investigation. The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The 47 NSQ samples identified by the central laboratories include Rabeprazole Tablets manufactured by Martin & Brown BioSciences Pvt. Ltd.; Paracetamol & Diclofenac Sodium Tablets manufactured by I.G. PHARMA LTD.; and Telmisartan Tablets IP by Orison Pharma International, among 44 others. Whereas, the list from state laboratories comprises Calcium & Vitamin D3 Tablets manufactured by Affy Parenterals Vill.; Phenytoin Tablets by Jackson Laboratories; and Cloprostenol Injection by Monatt Biotech, including 53 others. According to CDSCO, a drug shall be deemed spurious if it is manufactured under a name belonging to another drug; if it is an imitation of, or a substitute for, another drug; if it resembles another drug in a manner likely to deceive; or if it bears upon its label or container the name of another drug, among other provisions defined under Section 17-B of the Drugs and Cosmetics Act, 1940. Whereas drugs that fail to meet quality standards or specifications are notified as NSQ, a term defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Abhijeet Singh ,