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Pharma & Biotech

Immuron receives TGA GMP Clearance in Australia for packaging supplier

Immuron Ltd (NASDAQ:IMRN, ASX:IMC) has received Therapeutic Goods Administration (TGA) GMP Clearance for its packaging supplier allowing Travelan® to be released for sale in Australia to retail pharmacy wholesalers and other customers.

The company plans to release and dispatch Travelan® to customers this week.

About Travelan®

Immuron’s Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travellers’ diarrhea, a digestive tract disorder commonly caused by pathogenic bacteria and the toxins they produce.

Travelan® is a highly purified tabletised preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonisation and the pathology associated with travellers’ diarrhea.

Growing sales

On July 5, 2023, Immuron announced FY23 sales increase of 136% on FY22 sales and advised that until the TGA provided GMP Clearance for a new packaging supplier, Travelan® would be out of stock in wholesalers and pharmacies. If the company was able to supply product to wholesalers in June, the sales would have been even higher.

READ: Immuron nets 136% increase in global sales this year compared to financial year 2022

Resolution of the supply and stock outages will allow Immuron to continue anticipated growth in sales in Australia and also USA where Immuron recently launched on its own Amazon.com shopfront.

Immuron is focused on growing sales of its commercial products, expanding its portfolio of products and has a strong existing pipeline.

In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travelers’ Diarrhea, reduce the risk of minor gastrointestinal disorders and is antimicrobial.

About travellers’ diarrhea

Travellers’ diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal cramping, bloating and fever. Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli (ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of cases.

The more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the causative agent of cholera) are often confused with travellers’ diarrhea as they may be contracted while travelling and initial symptoms are often indistinguishable.

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