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5th FDA drug approval for the GBS Venture Partners portfolio

02 / 11 / 2020

On November 2 GBS investee Pharmaxis announced an FDA approval for Bronchitol, its treatment for cystic fibrosis patients.  

GBS Ventures Managing Director Brigitte Smith said, "A 1998 GBS investment, it has been a long road to FDA approval for Pharmaxis, but we are delighted for all those involved, including inventor Dr Sandra Anderson, founding CEO Alan Robertson, Initial ASX listing chair Denis Hanley, founding Chief Medical Officer Brett Charlton, CFO David McGarvey, and current CEO Gary Phillips.  These individuals and the broader Pharmaxis team have worked hard for two decades to bring this drug, which is manufactured in Sydney, to US patients."
This is the second FDA approval for the GBS portfolio this year, following the approval of Hatchtech developed Xeglyze for topical treatment of headlice in August.
GBS has backed four companies that have gained five FDA approvals for conditions including skin cancer, leukemia, respiratory diseases like asthma and cystic fibrosis, and headlice. Other approvals include Picato, commercialised by Peplin, and later Leo Pharmaceuticals for the treatment of actinic keratosis, a precancerous skin lesion, Synribo, commercialised by Chemgenex and later Teva for chronic myeloid leukemia, and Aridol, commercialised by Pharmaxis for the treatment of asthma and bronchiectasis. 
This is a material proportion of all of the drugs approved by the FDA from Australian companies, with only 13 drugs ever approved by the FDA from Australian companies.  Brigitte Smith commented, "the Pharmaxis Bronchitol approval follows an initial invention in Australia, and early development work in Australia with the support of the TGA, R&D tax credit programs, and Australian doctors and patients.  It is another great result for the country based on our strong early stage biotechnology industry."
For more information contact:
Brigitte Smith
Managing Director
GBS Venture Partners
+61 417 234 703