Guna Muppuri (left), CEO of Indies Pharma, and regulatory consultant Dr Nayeem Syed are seen photographed outside a production plant in India where the company's FDA-approved Regadenoson generic drug is manufactured.
Indies Pharma secures $60 million from first batch of FDA-approved drug
PHARMACEUTICAL company Indies Pharma Jamaica Limited has secured US$405,000 or just over $60 million in its first drawdown from the sale of its new Regadenoson generic drug approved by the US Food and Drug Administration (USFDA) last year.
Speaking with th Jamaica Observer on Friday, Guna Muppuri, CEO of Indies Pharma, expressed excitement about the product’s progress, calling it a major breakthrough for the company in the highly lucrative US pharmaceutical market, which is valued at billions.
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He anticipates that substantial revenue will continue to flow into the company as the drug gains wider distribution.
“As a USFDA drug, the first purchase order must be a validation batch and the total for that which we got was roughly $63 million or US$405,000,” he told Sunday Finance.
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The Regadenoson Injection, 0.4 mg/5 mL generic version developed by Indies Pharma is used to treat heart and other cardiovascular diseases. It is said to be bioequivalent and therapeutically equivalent to the brand name Astellas Pharma US Inc’s Lexiscan.
The drug is manufactured by a company in India.
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Following the signing of distribution agreements last year, the company — failing to disclose the identity of distributor approved during the fourth quarter of its last financial year — said an announcement will be made in short order as they take steps to finalise some contractual details during an upcoming meeting in the US.
Describing the drug’s USFDA approval as a historic milestone — the first of its kind for a Caribbean company— Muppuri expressed hope that this achievement would serve as a role model for other local pharmaceutical firms.
“Jamaica, and the people of Jamaica, must feel proud that one of their locally born and bred companies has been able to achieve this. As a competitor in the local market we’ve always sat and fought for market shares — which is very tiny in my view — so, for me, to have travelled across the ocean to tap into sales in the world’s most largest and lucrative market for pharmaceuticals is a very big deal. For this one drug, the market size per annum is bigger than Jamaica’s annual drug market turnover. There are about 10 players in the market now for this one drug, so it’s a bit competitive, but it’s big enough for each of us to earn,” Muppuri further told Sunday Finance.
As Indies Pharma ramps up its US operations, Muppuri revealed that a former board member has been appointed as his special advisor for operations and acquisitions in that market.
With plans on the horizon to develop more drugs, the CEO said the company, before pressing forward with this objective, will first move to develop its capital base.
“For sure that where we’re headed, as there is more opportunity for Indies Pharma to raise additional capital to acquire more drugs and that’s on the horizon,” he said.
For the first quarter ended January 31, 2025 Indies Pharma reported revenues of $325.8 million, with net profit totalling $74.2 million. The company’s total assets also grew to $2.4 billion over the three-month period.
“We’re very optimistic and very bullish on where the company is headed, and I want my investors to enjoy and reap the full benefits of all we are doing. This year we are looking to pay out $180 million in dividends,” Muppuri shared.
