GangaGen, the discovery and pre-clinical drug development major, is now in the midst of raising funds for its next phase of growth. The company is looking forward to garner Rs.20 crore (US$ 5million) and is in its final round of discussion.
“We will not be able to disclose the funding details at this stage. However, the funds will help conduct of clinical trials of StaphTAME,” Dr Janakiraman Ramachandran, founder and chairman, GangaGen told Pharmabiz.
The company is now ready with its proprietary recombinant protein P128, StaphTAME to tackle the antibiotic resistant Super Bug which is a threat in India, US and Europe. StaphTAME treats Methicillin-Resistant Staphylococcus Aure (MRSA) which is a difficult-to treat bacteria.
The company had a successful pre- IND(Investigational New Drug) meeting with the US FDA where it presented a proposal to conduct a combined phase I and II study. The extensive delays for approval in India led the company to look at other countries.
“Within a fortnight, the funding process would be cleared and we would be able to facilitate the StaphTAME clinical trials,” he added.
MRSA is a threat worldwide and the incidence of the bacterial infection in the intensive care units where patients using invasive devices and suffering from renal failure and open wounds, have weakened immune system are most susceptible.
“Therefore our StaphTAME, for the topical prevention and treatment of Staplylococcal infections is a product of the future. Once the clinical trials are complete, there will be a higher valuation for the company and we will be looking at either licensing the product to a multinational company to receive upfront or milestone payments,” informed Dr Ramachandran.
For the company, the focus in the next 24 months would be on StaphTAME and NDM-1. The latter is a phage derived recombinant protein to target gram negative E Coli. Once trials of StaphTAME are complete, it would raise additional funds to conduct human studies for NDM-1, said Dr Ramachandran.
Going by the business model of research, clinical trial data creation and out license, GangaGen has no need to expand its infrastructure or scientific personnel. While StaphTAME will be manufactured by Syngene Biocon subsidiary and the formulation would be by Kemwell, he informed.
Indian bio-pharma scene has been indicating promising growth prospects for developments of generics and biosimilars. But despite the reverse brain drain and support from the Department of biotechnology, India had a long way to go in catching up with the western world in the discovery and pre-clinical research. The country still had to put up with hitches in regulatory approval timelines among other hassles, stated Dr Ramachandran.
Trend in US and EU was on the advanced research on infection control with new drugs that could block secretion pathway of bacteria with the development of inhibitors, he said.
However, the global economic slowdown has impacted many global mid-sized bio-companies and the situation in India was far better, said Dr Ramachandran.