Indies Pharma targets US expansion

Indies Pharma targets US expansion

Commercialisation of two new generic drugs headlines American market push

Friday, November 06, 2020

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Indies Pharma, the Jamaican listed company, is expanding to the American pharmaceutical market that earned some US$490 billion in 2019.

The principals of Indies Pharma have hinted that its American expansion is very strategic, as the company is focusing on entering into areas of the United States pharmaceutical market for select generic drugs. Indies Pharma's selected target market for generic drugs in the United States is estimated to be worth some US$740 million of the overall US pharmaceutical market.

Indies Pharma American expansion is being financed by the $805 million raised on the local capital market through a successful private placement earlier this year. The private placement was arranged by Sagicor Investments Limited.

Indies Pharma Chief Executive Officer (CEO) Dr Guna Muppuri disclosed that approximately $405 million of the bond proceeds is being invested in the development of two generic drugs and their submission for approval by the United States Food and Drug Administration (USFDA). The development of the two drugs will give the company access to the US market through the growing demand for generic drugs.

This will allow Indies Pharma further reach outside of Jamaica while allowing the business to carve out a sizeable share and presence in one of the world's most highly regulated and lucrative markets. Dr Muppuri points out that after successfully developing its two new drug formulations earlier this year, Indies Pharma engaged a US-based manufacturing partner and transferred the drug technology to produce the first exhibit batch of the finished formulations.


The two drug formulations are expected to be ready by March 2021 for further testing, and the full dossiers being filed in the third quarter of 2021 for final USFDA approval. Indies Pharma will file an Abbreviated New Drug Application (ANDA) for US market approval in 2021 with full approval expected by 2023, at which time Indies Pharma will be launched in the US market.

Dr Muppuri says this timeline gives Indies Pharma two years' lead ahead of the bond maturity date in 2025 to realise revenues from the commercialisation of its generic drugs in the US market. The expected wait time for final approvals is two years, which falls in line with the target date of the third quarter of 2023 for the first commercial sale of the products on the US market.

According to the Dr Muppuri, “Indies Pharma intends to develop additional generic drugs for approval for the US market over the next three years targeting in excess of a US$3 billion block of the multi-billion generic pharmaceuticals market and has investment plans for 20 drug approvals at a cost of approximately US$40 million....with our planned entry into the US market, Indies Pharma would also be assisting patients in that large market to access medicines at an affordable cost, which is the company's mission.”

The Indies Pharma CEO says the Jamaican company is looking to gain some five per cent of the targeted US market share of US$740 million from its Abbreviated New Drug Applications. This would translate to US$37 million or approximately J$5.4 billion per year in new annual earnings. Indies Pharma earned J$729.4 million in 2019.


There are also other commercialisation plans in the pipeline. Once approvals are obtained for the US market, the company intends to explore the opportunity to out-license its intellectual property – drug development technology – to other global markets for a fee, profit share or through royalty arrangements.

“Indies Pharma is keen to make the most of the global opportunities. We are willing to take carefully calculated risks looking beyond the horizon for global opportunities and are not daunted by the COVID-19 threat,” Dr Muppuri points out.

Drug shortages and supply chain disruptions caused by the pandemic are creating particular advantages for companies, like Indies Pharma, that can maintain high production standards and keep their production and supply infrastructure intact to plug important market gaps. More than a year ago, the majority shareholding entity of Indies Pharma, Bioprist Group, successfully conducted a thorough research of the US market.

This push to penetrate the American market is taking place despite the global business downturn caused by the coronavirus pandemic and the challenge being faced locally by Indies Pharma arising from the global pandemic. Rather than being daunted, the Indies Pharma CEO says the pandemic is creating market penetration opportunities in the global pharmaceutical trade and health-care segments.


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