Indies Pharma Jamaica Limited has made history as it became the first Jamaican company to get an ANDA (Abbreviated New Drug Application) approved by the United States Food and Drug Administration (FDA), which has unlocked a new US$400-million market for the company.

The Jamaican pharmaceutical distribution company received approval from the USFDA on August 22 for its new generic drug, Regadenoson, which has a strength of 0.4mg/5ml (0.08mg/ml). Regadenoson is a stress agent/molecule that’s used to increase the blood flow in the arteries of the heart before a patient is required to undergo radionuclide myocardial perfusion imaging (PMI) or X-ray imaging of blood flow through the heart to test for coronary heart disease. This molecule is used for patients who are unable to undergo adequate exercise stress for other diagnostic heart tests. Regadenoson is administered intravenously and is given by way of a doctor’s prescription.

“One drug has surpassed almost the whole of Jamaica’s market size. We are among one of those top players in the United States [of America] for now. It’s limited to the United States only and then we can now licence it to Europe. The global intellectual property (IP) is ours,” said Dr Guna Muppuri, Indies Pharma’s founder, executive chairman, president and chief executive officer (CEO), in a call with the Jamaica Observer on Tuesday.

An ANDA is a way for other pharmaceutical companies to develop generic drugs with therapeutical equivalence and bioequivalence to the innovator drug or the originally created drug. A generic drug through this ANDA process is required to perform the same way as the innovator drug by delivering the same amount of active ingredients to a patient’s bloodstream in the same amount of time.

The development of generic drugs is what leads to cheaper alternatives to the innovator drug, which enjoys patent protection of 20 years, something provided to allow the developer and investors to recover their investments. So while sildenafil is the active drug in Viagra, other companies were able to introduce generics to the US market 20 years after Pfizer’s patent ran out.

In this case, Indies version of Regadenoson is bioequivalent and therapeutically equivalent to Astellas Pharma US Inc’s Lexiscan (Regadenoson Injection). Indies Pharma has invested over $447.05 million in the last four years to develop two drugs through an agreement with KP Pharmaceutical Technology Inc, a contract research organisation based in Bloomington, Indiana, USA.

In its disclosure to the Jamaica Stock Exchange (JSE), Indies Pharma referenced IQVIA, a company listed on the New York Stock Exchange, which estimated that there was US$668 million in sales for Regadenoson over the 12 months ending February 2023. With more generics entering the market, it is expected that these sales will be reduced to under US$400 million over time. When Indies Pharma had mentioned the marketing of this drug in its May 2022 annual general meeting, it was estimated at US$680 million at the time.

While Indies Pharma is celebrating the success of its first drug, it is planning to divest the anti-cancer drug it was working on, which had a market size of US$60 million.

“We’re divesting that one for now, because the market has shrunk and we are looking to divest it. We’d exit and reinvest it in something else. It’s not even 10 per cent of this market size now,” Dr Muppuri explained on the second drug.

Indies version of Regadenoson had an ANDA number of 218054 and has been registered with the National Drug Codes List number of 83032-001.

“When you get approvals, we have to engage proper distributors who can distribute our product all over the United States. We are discussing with two major players who don’t have this drug to distribute. We’re currently doing due diligence on the two parties, and we have a meeting scheduled this week. I strongly believe we can complete the engagement process this month because we have 30 days’ time at our disposal to secure the distributor,” Dr Muppuri explained regarding the next step forward for a distributor.

While the jubilant CEO wouldn’t immediately mention the expected revenue inflows, he did mention that the sales should be reflected in the 2025 financial year (FY) which starts on November 1. Indies Pharma raised a $805-million private placement in September 2020 to invest in the development of the new drugs and a St James property. That private placement document mentioned Indies Pharma’s projected revenues and profitability for these new drugs.

“Production takes next 90 days or less, because now you need to procure the raw material and then have it produced. We have up to November or December to have product arriving in the United States. We would have the [original] approvals by the gold date November 2024. We’re at least eight weeks ahead of the gold date,” the founder said with respect to when production should begin.

Despite the positive outlook on the USA and other markets, Dr Muppuri lamented the delay it takes for new drugs to be approved in Jamaica. He noted that while the process would have been impacted by the COVID-19 pandemic, the extended delay is of concern since the new drugs which would enter the market would be markedly cheaper than other products on the market.

“I’m not happy with the expectations that I have from the Jamaican market, because Jamaica’s standards and regulations on pharmaceutical regulatory affairs unit has not delivered even one registration for us in the last five years. We’ve submitted more than 50 new drug dossiers, and they’ve not delivered. In these three years, we went and invested money with USFDA. If Indies Pharma could pass the scrutiny and quality of the USFDA, who is convinced and impressed, why are we not getting approvals in Jamaica,” Muppuri queried on the delays for the approval of new drugs in Jamaica.

Although Indies Pharma had expected to be completed with a new knowledge and processing centre in Montego Park Estate, Ironshore, St James, by the end of 2023, the company is currently awaiting additional approvals to get full steam ahead. The three-acre property is supposed to house business processing outsourcing (BPO) operations and the company’s permanent head office with a bigger warehouse to store pharmaceutical drugs. The property is currently held through its subsidiary Indies Pharma Business Park Limited and was acquired for $405.82 million. It was last valued at $765 million as per its 2023 financials.

“We just got NEPA [National Environment and Planning Agency] approvals and the [St James] Parish Council is waiting on NWA [National Works Agency] which asked for some changes. We’re currently waiting on NWA to give their okay, because we’ve made the changes and submitted them. If all goes well, we should receive the approvals next month,” he explained.

Indies’ six months revenue is up 17 per cent to $570.78 million, with its operating profit rising 46 per cent to $179.59 million. Although its profit before tax is up 72 per cent to $151.74 million, its net profit only increased 51 per cent to $133.56 million due to it now being subject to a 50 per cent tax remission. The company listed on the Jamaica Stock Exchange in August 2018.

Total assets for the six months were up five per cent to $2.35 billion, with inventories at $314.96 million and cash at $234.62 million. Total liabilities and shareholder’s equity were $997.14 million, respectively.

Indies Pharma’s stock price has increased five per cent since Friday to close Tuesday at $2.78 with a market capitalisation of $3.71 billion. Indies Pharma paid a $0.11 dividend totalling $146.58 million on July 31. Indies Pharma is set to have its board meeting for the publication of its third quarter results on Friday.

It should be noted that Bioprist Holdings Inc, Indies largest shareholder that is connected to Guna and Vishnu Muppuri, sold 34,365,000 shares on November 29 at $2.43 totalling $83.51 million. NCB Capital Markets’ Caribbean Equity Portfolio unit trust appeared as the fifth largest shareholder with 20 million shares in the January shareholder list alongside Barita Investments Limited that now owns 17,894,568 shares as the sixth largest shareholder. GK Investments Limited has continued buying pushing its stake to 55,875,354 shares as the second largest shareholder. Vishnu is now the fourth largest shareholder, with 23,171,070 shares in the place of Venugopal Naidu Kuntamukkala.

“We’re intuition-driven and know what we’re getting into. We made it, and at least this will pave the way for many companies in Jamaica trying to venture into the United States. Stay in Jamaica, shoot for the stars. We’ve listed one company here, and one day we need to list something on the New York Stock Exchange. That’s the kind of vision I have,” Muppuri closed.