ADMA Biologics Inc's (NASDAQ:ADMA) stock rocketed Tuesday after the US Food and Drug Administration approved ASCENIV, formerly referred to as RI-002, as an Intravenous Immune Globulin (IVIG), for managing Primary Humoral Immunodeficiency Disease (PIDD) stemming from disorders resulting from the mostly inherited defects of the immune system.
Investors cheered the news that the company expects to have the product available for commercial launch in the second half of 2019 and sent shares in ADMA Biologics flying 53% to $6.23.
RI-002 is the company's lead pipeline product candidate that has completed its Phase III trial, which hit both primary and secondary endpoints. RI-002 is created from a blend of normal donor plasma and plasma from donors with high Respiratory Syncytial Virus "RSV" titers.
READ: ADMA Biologics outlook rosy after manufacturing facility gets FDA compliance approval, says Baird report
“We are excited about this significant achievement in receiving FDA approval for ASCENIV, a novel patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PIDD,” said ADMA Biologics CEO Adam Grossman in a statement. “We hope availability of ASCENIV will help ameliorate a portion of the current shortages facing US IVIG supply.”
Grossman said there are approximately 250,000 PIDD patients diagnosed and living in the US.
“We believe there is an opportunity to treat meaningful segments of this patient population with ASCENIV,” said Grossman.
A blend of donor plasma
RI-002 is created from a blend of normal donor plasma and plasma from donors with high Respiratory Syncytial Virus "RSV" titers.
“As previously disclosed, ASCENIV is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization assay,” said Grossman.
The CEO said the FDA approval better positioned the company to “further its mission” to evaluate ASCENIV in immune-compromised patients infected with or at-risk for Respiratory Syncytial Virus infection.
“We look forward to working with the FDA and the immunology and infectious disease community on developing a clinical investigation to evaluate use of ASCENIV in this patient population in the near future,” said Grossman.
The company said that ASCENIV’s FDA approval triggers funding up to $27.5 million from an existing credit facility.
“This option remains available to the Company through June 2020, and such funds could be used to support the launch of ASCENIV, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities,” said Grossman.
The Ramsey, New Jersey-based biopharmaceutical and specialty immunoglobulin company, develops and manufactures specialty plasma-derived biologics for the treatment of immune deficiencies and infectious diseases. The company also has offices in Boca Raton, Florida.
Contact Uttara Choudhury at [email protected]