Metronidazole

Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2024

Retrieved on: 
Tuesday, February 13, 2024

HALIFAX, Nova Scotia, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX:APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the third quarter of its fiscal year 2024, which ended on December 31, 2023. All figures are stated in Canadian dollars unless otherwise stated.

Key Points: 
  • In September 2023, Appili announced the FDA approval of LIKMEZ™ (ATI-1501) , our proprietary taste-masked liquid suspension reformulation of metronidazole, through our U.S. partner, Saptalis Pharmaceuticals LLC.
  • Collaborating with Saptalis, Appili earned US$600,000 in milestone payments in fiscal 2024.
  • Appili was granted a pre-IND meeting with the FDA to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1 strategies and expects to receive feedback in early 2024.
  • As of February 13, 2024, the Company had 121,266,120 issued and outstanding Common Shares, 7,957,000 stock options, and 44,856,874 warrants outstanding.

Why it’s a bad idea to mix alcohol with some medications

Retrieved on: 
Monday, February 12, 2024

But you may not be aware that mixing certain medicines with alcohol can increase the effects and put you at risk.

Key Points: 
  • But you may not be aware that mixing certain medicines with alcohol can increase the effects and put you at risk.
  • When you mix alcohol with medicines, whether prescription or over-the-counter, the medicines can increase the effects of the alcohol or the alcohol can increase the side-effects of the drug.
  • This is because there is less water in their bodies that can mix with the alcohol.
  • If you do want to drink alcohol while being on medication, discuss it with your doctor or pharmacist first.

Kesin Pharma Announces FDA Approval and U.S. Availability of LIKMEZ™ (metronidazole) Oral Suspension

Retrieved on: 
Tuesday, November 14, 2023

Kesin Pharma Corporation, a pharmaceutical company focused on innovative Specialty brands and Unit Dose formulations, announced today that the U.S. Food and Drug Administration (FDA) has approved LIKMEZ™ (metronidazole) oral suspension, 500 mg/5 mL.

Key Points: 
  • Kesin Pharma Corporation, a pharmaceutical company focused on innovative Specialty brands and Unit Dose formulations, announced today that the U.S. Food and Drug Administration (FDA) has approved LIKMEZ™ (metronidazole) oral suspension, 500 mg/5 mL.
  • Available now, LIKMEZ™ is the first and only FDA-approved ready-to-use oral liquid metronidazole in the U.S. market.
  • Kesin is the exclusive U.S. commercialization partner for LIKMEZ™ through its collaboration with Saptalis Pharmaceuticals, LLC, the developer and NDA holder of the product.
  • The timely approval of this NDA505(b)(2) presents a significant opportunity for Kesin Pharma to bring a value-added product to the market,” said Narasimhan Mani.

Appili Therapeutics Announces U.S. FDA Approval of LIKMEZ™ (ATI-1501) Metronidazole Oral Suspension

Retrieved on: 
Monday, September 25, 2023

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) received approval from the U.S. Food and Drug Administration ("FDA”) for Metronidazole Oral Suspension 500mg/5mL ( ATI-1501 ).

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced that its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC (“Saptalis”) received approval from the U.S. Food and Drug Administration ("FDA”) for Metronidazole Oral Suspension 500mg/5mL ( ATI-1501 ).
  • ATI-1501, Appili’s liquid oral reformulation of the antibiotic metronidazole, has been licensed to Saptalis for commercialization in the U.S., and other selected territories.
  • “We are proud of our team which, using Appili’s taste masking technology, has successfully developed a commercial product approved by the FDA.
  • Appili expects to receive milestone payments and royalties from Saptalis based on this FDA approval and Saptalis’ commercialization plans.

Appili Therapeutics Reports Financial and Operational Results for First Quarter of Fiscal Year 2024

Retrieved on: 
Friday, August 11, 2023

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the first quarter of its fiscal year 2024, which ended on June 30, 2023.
  • These achievements are expected to position us with the required resources to continue to make progress in advancing our infectious disease assets."
  • On May 5, 2023, Appili executed an initial cooperative agreement with USAFA the previously announced funding of the ATI-1701 program.
  • This initial funding, in the amount of US$7.3 million, will be used to kick-off ATI-1701 early-stage development and regulatory activities.

Cosette Pharmaceuticals Launches Metronidazole Vaginal Gel 0.75%, AB-rated to MetroGel-Vaginal® 0.75%

Retrieved on: 
Thursday, July 27, 2023

Cosette Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of MetroGel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health US, LLC.

Key Points: 
  • Cosette Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for a generic version of MetroGel-Vaginal® (metronidazole vaginal gel 0.75%) by Bausch Health US, LLC.
  • View the full release here: https://www.businesswire.com/news/home/20230727123074/en/
    “We are thrilled at the approval and launch of an additional affordable alternative product, serving women’s health.
  • We will continue to deliver on our commitment to provide important, high-quality, affordable medicine for patients in women’s healthcare” said Apurva Saraf, President and CEO of Cosette Pharmaceuticals.
  • According to IQVIA™ data, U.S. annual sales for metronidazole vaginal gel 0.75% for the 12 months ended December 2022 totaled approximately $45 million.

Appili Therapeutics Reports Fiscal Year 2023 Financial and Operational Results

Retrieved on: 
Friday, June 23, 2023

Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024.

Key Points: 
  • Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense products, today announced its financial and operational results for the fiscal year ended March 31, 2023, and provided an update on the Company’s strategy for fiscal 2024.
  • In May 2023, Appili executed the initial contract with USAFA (the “USAFA Cooperative Agreement”) for the previously announced funding of the ATI-1701 program.
  • Appili has submitted its first invoice for such costs and anticipates receiving payment by the end of June 2023.
  • The Company has included a going concern note in its financial statements for the fiscal year ended March 31, 2023.

Appili Therapeutics Announces Issuance of Patent for ATI-1501 Liquid Oral Reformulation of Metronidazole

Retrieved on: 
Wednesday, May 24, 2023

18/072,154 filed on November 30, 2022 and titled “Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same”.

Key Points: 
  • 18/072,154 filed on November 30, 2022 and titled “Oral Formulations of Metronidazole and Methods of Treating an Infection Using Same”.
  • Metronidazole is a widely used frontline oral treatment with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections.
  • “We believe our liquid oral reformulation solves a significant and growing issue for patients who cannot tolerate the current tablet formulation of metronidazole, especially for the elderly and children who often have difficulty taking solid oral medicines” said Don Cilla, Pharm.D., M.B.A., President and Chief Executive Officer of Appili Therapeutics.
  • “This patent recognizes innovative research by Appili Therapeutics to fill this significant gap in the treatment paradigm, and further strengthens ATI-1501’s position as a more convenient antibiotic treatment option on the market.

Acurx Announces Ibezapolstat Scientific Poster and Update on its Pol IIIC Pipeline Presented at ECCMID 2023 Scientific Conference

Retrieved on: 
Wednesday, April 19, 2023

C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.

Key Points: 
  • C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.
  • To study anti-virulence effect, our group investigated an under-studied virulence property of C difficile, namely, flagellar movement of the organism.
  • All of these positive and unexpected findings reflect the unique mode of action in inhibiting DNA pol IIIC and support the continued development of ibezapolstat to treat C. difficile infection."
  • The poster and presentation are available on the Company's website www.acurxpharma.com.

Appili Therapeutics Reports Financial and Operational Results for Third Quarter of Fiscal Year 2023

Retrieved on: 
Tuesday, February 14, 2023

Appili Therapeutics Inc. (TSX: APLI, OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the third quarter of its fiscal year 2023, which ended on December 31, 2022.

Key Points: 
  • Appili Therapeutics Inc. (TSX: APLI, OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today announced its financial and operational results for the third quarter of its fiscal year 2023, which ended on December 31, 2022.
  • We are working diligently with our partner, Saptalis, and the FDA on receiving NDA approval and preparing for market launch.
  • There is currently no approved vaccine for the prevention of tularemia in the United States or other major global markets.
  • As of February 13, 2023, the Company had 121,226,120­ issued and outstanding Common Shares, 8,081,772 ­stock options, and 51,317,879­­ warrants outstanding.