Indies Pharma Jamaica Limited has achieved a significant milestone by securing FDA approval for its generic drug, Regadenoson, a stress agent used in cardiac imaging. This approval marks the first time a Jamaican company has received such clearance from the USFDA, opening access to a US$400 million market. The generic drug is therapeutically equivalent to Astellas Pharma US Inc’s Lexiscan, offering a more affordable option for patients needing cardiac stress tests.
FDA Approval and Market Opportunity
On August 22, the USFDA approved Indies Pharma's Abbreviated New Drug Application (ANDA) for Regadenoson, with a strength of 0.4mg/5ml (0.08mg/ml). Regadenoson is crucial for patients unable to undergo adequate exercise stress during radionuclide myocardial perfusion imaging (PMI) or X-ray imaging to detect coronary heart disease. The drug is administered intravenously and requires a doctor's prescription.
Dr. Guna Muppuri, Indies Pharma’s founder, executive chairman, president, and CEO, highlighted the significance of this achievement: "One drug has surpassed almost the whole of Jamaica’s market size. We are among one of those top players in the United States for now... The global intellectual property (IP) is ours."
IQVIA data indicates that Regadenoson had US$668 million in sales for the 12 months ending February 2023. However, with increasing generic competition, sales are expected to decrease to under US$400 million. Indies Pharma aims to capture a significant share of this market with its generic version.
Development and Production
Indies Pharma invested over $447.05 million in the last four years to develop two drugs through an agreement with KP Pharmaceutical Technology Inc. While celebrating the success of Regadenoson, the company plans to divest its anti-cancer drug project due to a shrinking market.
Production of the generic Regadenoson is slated to begin within 90 days, with the product expected to arrive in the United States by November or December 2024. The company is currently in discussions with major distributors to ensure widespread availability across the United States.
Financial Projections and Future Growth
Indies Pharma anticipates that sales of Regadenoson will significantly boost its revenue, potentially doubling total revenue to $2-3 billion by FY2025. In the previous financial year, Indies Pharma recorded total revenue of $1.06 billion (US$6.72 million).
Dr. Muppuri expressed optimism about the company’s financial future, stating, "My conservative estimate is that our total revenue should at least double. I go further to say that a better estimate would be in the order of $3 billion, and the bottom line should perform in the same way."
Challenges and Expansion
Despite successes in the US market, Indies Pharma faces challenges in Jamaica, citing delays in drug approval processes. Dr. Muppuri voiced concerns over the lack of approvals from Jamaican regulatory bodies despite the company meeting stringent USFDA standards.
Indies Pharma is also awaiting final approvals for its new knowledge and processing center in Montego Bay, which will house BPO operations and a larger warehouse for pharmaceutical drugs. The company's six-month revenue is up 17% to $570.78 million, with operating profit rising 46% to $179.59 million.
