ADMA

Nabi-HB®

Primary Immune Deficiency Disease (PI)

Stage (next event)

Next Event

Expected Date

Approved

Quarterly Sales

March 05, 2021 (Est)

Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception

Catalyst Info & Data Links

MORE INFORMATION:

  • Package Insert

  • Achieved Fourth Quarter 2020 Preliminary Unaudited Total Revenues of $13.9 Million, the Highest Revenue Quarter for the Company Since Inception



DRUG HISTORY:


Mechanism of Action

Nabi-HB® is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB® is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB® is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (“HBsAg”), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB® has a well-documented record of long-term safety and effectiveness since its initial market introduction. FDA approval for Nabi-HB® was received on March 24, 1999. Biotest acquired Nabi-HB® from Nabi Biopharmaceuticals in 2007. ADMA obtained ownership and all rights, title and interest in Nabi-HB® in June 2017 as part of the BTBU asset acquisition and the FDA transferred the BLA to ADMA on July 2, 2019.  Certain data and other information about Nabi-HB® or ADMA Biologics and its products can be found on the Company’s website at: www.admabiologics.com.

MARKET

  • PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.  According to the World Health Organization, there are approximately 350 different genetic mutations encompassing PI. Some disorders present at birth or in early childhood, the disorders can affect anyone regardless of age or gender. Some affect a single part of the immune system, others may affect one or more components of the system. PI patients are vulnerable to infections and more likely to suffer complications from these infections as compared to individuals with a normal functioning immune system. The infections may occur in any part of the body. Because patients suffering from PI lack a properly functioning immune system, they typically receive monthly treatment with polyclonal immune globulin products. Without this exogenous antibody replacement, these patients would remain vulnerable to persistent and chronic infections. PI has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people in the U.S.

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