Indies Pharma looking to double sales after securing FDA drug approval

Drug company Indies Pharma Jamaica Limited is looking to double next year’s revenues, following approval of its abbreviated new drug application, referred to as ANDA or, more simply, generic drug, by the Food and Drug Administration of the United States, three months earlier than expected.

Indies Pharma applied to the FDA in January 2023, for which a decision was expected in November, but got approval on August 22 for a generic version of Regadenoson Injection, 0.4 mg/5 mL, which treats heart disease.

Indies Pharma CEO Guna Muppuri said the generic drug was “exclusively 100 per cent the intellectual property of’ the company”. It is being manufactured under contract by an unnamed company near Delhi in India.

Regadenoson “is a unique and rare drug used specifically with patients suffering from heart diseases and who have to undergo certain tests,” he told the Financial Gleaner in-between conference calls aimed at finalising distribution arrangements for the generic form of the drug.

Last year, Indies Pharma recorded total revenue of $1.06 billion, which is about US$6.72 million, for its financial year ending October 2023. Muppuri is now looking to hit the $2-billion mark, and possibly $3 billion by FY2025.

The company’s third-quarter results for FY2024 are pending, but its half-year sales annualises to $1.15 billion for FY2024. Indies Pharma’s generic form of Regadenoson won’t hit the market before year end, and therefore its impact won’t be felt until next year.

Regadenoson itself is sold under the brand name Lexiscan, among others. It was approved by the FDA in 2008, and was said by Muppuri to have racked up sales of US$668 million over 12 months to February 2023, in the United States.

Now he is aiming for some of that market.

Indies Pharma will release its drug on the market as ‘a generic form of Regadenoson’.

“In the US, it cannot be given another name, it just has to be marketed as the generic form on the drug,” Muppuri said.

“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,” the Indies Pharma CEO declared, regarding his company’s expected performance once the generic drug hits the market.

Indies Pharma is aiming to commercialise the drug in the United States by or before the end of 2024, or at the very latest, January 2025. Sales will initially focus on the United States market.

Muppuri says Indies Pharma will be utilising the services of two companies to distribute the drug throughout the US market.

“We’re targeting every hospital in the United States that does cardiovascular procedures. Wherever this drug is required, we will have it sold. There is no restriction. We are talking about the US mainland and as far as American Samoa, Guam, and right back to Puerto Rico,” he said.

The businessman also spoke proudly of the accomplishment of bringing a drug to market in the tough pharma sector.

“We like to think of ourselves as the trendsetter. We don’t want to go after the me-too drugs. We have to cherry-pick the best so that there is less competition, while matching our intellectual capabilities and staying with the horizon in sight,” Muppuri said.

“The same amount of pride that comes with the mention of Usain Bolt, it’s the same amount of pride that we should feel about this approval and the possibilities.”

He spoke critically of the slow pace of approvals coming from the Ministry of Health in Jamaica, saying that since 2018, Indies Pharma had found it difficult to secure any approvals from the ministry, whereas it took the FDA less than two years to review and approve his application.

“The approval that we secured today will be for drugs that will be sold in the US market. It will not be for the Jamaican market, and clearly, the Jamaican people will be losing,” Muppuri said.

The development of the drug was financed from half the proceeds of a $805-million bond raised by the company in June 2020. The other half of the proceeds funded the acquisition of land in Ironshore, Montego Bay, where Indies Pharma is based.

The bond is due for repayment in 2025, but Muppuri now expects to repay it earlier.

“With the projections that we have, we can see ourselves retiring this debt ahead of time,” he said.

The property acquired has already appreciated in value, from $400 million to $800 million; plus, revenue is projected to grow due to the newly approved drug, he noted.

neville.graham@gleanerjm.com