Full Press Release Details
ADMA Biologics Announces Data Presented
RAMSEY, N.J. and BOCA RATON, FL., - October 7, 2019 -
ADMA Biologics, Inc. (NASDAQ: ADMA) ("ADMA" or the "Company"), a vertically integrated commercial biopharmaceutical
and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment
of immune deficiencies and the prevention of certain infectious diseases, announces that a poster presentation was given at
IDWeek 2019, the combined annual meeting of IDSA, SHEA, HVMA and PIDS in Washington, D.C. The poster detailed data obtained from
the compassionate use of ASCENIV (formerly referred to as RI-002) in the treatment of Respiratory Syncytial Virus ("RSV")
infection in two immunocompromised children.
The two immunocompromised children admitted to the Mayo Clinic
each were diagnosed with T-cell lymphoblastic lymphoma. Both patients were undergoing delayed intensification chemotherapy and
each were diagnosed with RSV Lower Respiratory Tract Infection ("LRTI"). Both children were treated with ASCENIV
under an emergency United States Food and Drug Administration ("FDA") Investigational New Drug protocol.
The treatment and results of patient one are as follows - Patient
was admitted with fever, neutropenia, nasal congestion and diagnosed with RSV infection on hospital day five. On hospital day 17,
the patient was intubated for respiratory failure. Intravenous Immune Globulin ("IVIG") and palivizumab, and daily
oral ribavirin were administered. On hospital day eighteen, the patient required high frequency oscillator ventilation, nitric
oxide and paralysis. The patient was then administered ASCENIV 1.5g/kg on hospital day twenty and 0.75g/kg on hospital day
twenty-two. The patient was placed on veno-venous Extracorporeal Membrane Oxygenation ("ECMO") on hospital day twenty-three.
On hospital day thirty-three, a third dose of ASCENIV was given at 0 .75 g/kg. The patient's pulmonary compliance
and chest CTs improved. On day fifty-two, ECMO support was discontinued and the patient was discharged from the hospital on hospital
day eighty-eight, and currently requires no respiratory support.
The treatment and results of patient two are as follows - Patient
was admitted with fever, neutropenia, nasal congestion, cough and stridor and diagnosed with RSV infection on hospital day one.
The patient required nasal cannula oxygen. IVIG and daily oral ribavirin were administered. The patient was administered ASCENIV
1.5g/kg on hospital day three and 0.75g/kg on hospital day five. By hospital day five, the patient was afebrile; oxygen was discontinued
and the patient was discharged from the hospital on hospital day six.
The data in the poster and abstract concludes that the evaluated
product may be useful in the treatment of severe RSV infections and may assist in prevention of progression of RSV lower respiratory
tract infection. The data also confirms that further evaluation of ASCENIV in this patient population is warranted.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures and markets three United States
Food and Drug Administration ("FDA") approved plasma-derived biologics for the treatment of immune deficiencies and
the prevention of certain infectious diseases. ADMA's mission is to manufacture, market and develop plasma-derived, human
immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management
of immune compromised patient populations who suffer from an underlying immune deficiency disease, or who may be immune compromised
for other medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 related to
certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
About ASCENIV (Formerly referred to as RI-002)
ASCENIV , Immune Globulin Intravenous, Human - slra 10% Liquid, is a plasma-derived, polyclonal, intravenous immune
globulin ("IVIG"). ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. 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. ASCENIV contains
naturally occurring polyclonal antibodies. ASCENIV is indicated for the treatment of Primary Humoral Immunodeficiency
or Primary Immune Deficiency Disease ("PI") in adults and adolescents (12 to 17 years of age). ADMA received
FDA approval for ASCENIV on April 1, 2019. Polyclonal antibodies are proteins that are used by the body's immune
system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV prevented
serious bacterial infection among 59 patients treated for twelve months during the pivotal investigation. The most common
adverse reactions to ASCENIV (>5% of study subjects) were headache, sinusitis, diarrhea, gastroenteritis viral,
nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea. ADMA anticipates the commercial launch of ASCENIV
during the fourth quarter of 2019. Certain data and other information about ASCENIV or ADMA Biologics and its products
can be found on the Company's website at: www.admabiologics.com.
Additional Important Safety Information about ASCENIV
ASCENIV (immune globulin intravenous, human - slra)
is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI)
in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital
agammaglobulinemia, common variable immunodeficiency (CVID), X linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe
combined immunodeficiencies (SCID).
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
Thrombosis may occur with immune globulin (IGIV) products,
including ASCENIVTM. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history
of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk
factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis,
and death may occur with the administration of IGIV products in predisposed patients.
Renal dysfunction and acute renal failure occur more commonly
in patients receiving IGIV products containing sucrose. ASCENIVTM does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or
renal failure, administer ASCENIVTM at the minimum dose and infusion rate practicable. Ensure adequate hydration in
patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for
ASCENIV is contraindicated in:
Warnings and Precautions
Severe hypersensitivity reactions may occur with IGIV products,
including ASCENIV . In case of hypersensitivity, discontinue ASCENIV infusion immediately and institute appropriate
treatment. Medications such as epinephrine should be available for treatment of acute hypersensitivity reactions.
Thrombosis may occur following treatment with immunoglobulin
products, including ASCENIV . Thrombosis may occur in the absence of known risk factors.
Acute renal dysfunction/failure, osmotic nephrosis, and death
may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering ASCENIV . Periodic
monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing
acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia
may occur in patients receiving IGIV treatment, including ASCENIV .
Aseptic meningitis syndrome (AMS) may occur with IGIV treatments,
including ASCENIV . AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
IGIV products, including ASCENIV , may contain blood group
antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive
direct antiglobulin reaction and hemolysis.
Monitor patients for pulmonary adverse reactions. If TRALI is
suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and the patient's
Because ASCENIV is made from human blood, it may carry
a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob
disease (CJD) agent.
Periodic monitoring of renal function and urine output is particularly
important in patients at increased risk of developing acute renal failure. Assess renal function, including measurement of blood
urea nitrogen (BUN) and serum creatinine, before the initial infusion of ASCENIV and at appropriate intervals thereafter.
After infusion of immunoglobulin, the transitory rise of the
various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the
potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause
a positive direct or indirect antiglobulin (Coombs') test.
The most common adverse reactions to ASCENIV ( 5%