Indies Pharma Receives USFDA Drug Approval

  • Indies Pharma created history by becoming the very first Jamaican Company to receive the U.S. Food and Drug Administration (USFDA) approvals for an ANDA (generic drug). The USFDA approved Indies’ abbreviated new drug application on the 22nd day of August 2024. The USFDA determined that the company’s “Regadenoson” is bioequivalent and therapeutically equivalent to Astellas Pharma U.S., Inc.'s Lexiscan® (Regadenoson Injection).
  • Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
  • This drug approval will allow Indies to enter the US market of approximately US$400 Million. With an aim to commercialize this product in the United States by or before the end of 2024, the company has initiated the process of entering distribution arrangements with a few drug distributors in the United States.
  • This was one of the company’s most anticipated drug approvals, which was originally scheduled for November 2024. However, it has been approved earlier than expected. A portion of the company’s bond funds, its growth capital, was used to develop this drug to gain entry into the US market.
  • According to IQVIA, US sales of Regadenoson Injection, 0.4mg/5mL, were approximately US$668 Million per annum in the 12 months ending February 2023. With the approvals being granted for the generic versions, the dollar value for this particular drug in the United States is bound to decline, and it is speculated to fall to under US$400 Million per annum.
  • The integration of these drugs into the US market is expected to support strong business growth and serve as a major earnings driver. Additionally, the company is also actively researching to identify new generic drugs to introduce into the US market.
  • Indies’ stock price has decreased by 4.8% since the start of the calendar year. The stock closed Monday’s trading session at $2.76 and currently trades at a P/E of 14.4x, which is below the Junior Market Heath Sector Average of 16.0x.

(Sources: JSE and NCBCM Research)