UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 12, 2023
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code: (201 )
478-5552
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Other Events
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On December 12, 2023, ADMA Biologics, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has approved
the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM®. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein.
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Item 9.01
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Exhibits.
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(d) Exhibits
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ADMA Biologics, Inc. Press Release, dated December 12, 2023
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104
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Cover Page Interactive Data File (embedded with the Inline XBRL document)
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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December 12, 2023
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ADMA Biologics, Inc.
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By:
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/s/ Brian Lenz
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Name:
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Brian Lenz
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Title:
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Executive Vice President and
Chief Financial Officer
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Exhibit 99.1
ADMA Biologics Announces FDA Approval for BIVIGAM® in the Pediatric Patient
Setting for Those 2 Years of Age and Older
Signifies the Successful Fulfillment of BIVIGAM’s Post Marketing Commitments as Part of the Original BLA Approval
Expanded Label in the U.S. Now Includes Pediatric PI Patients 2 Years of Age and Older
RAMSEY, N.J. and BOCA RATON, Fla., Dec. 12, 2023-- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics,
today announced the U.S. Food and Drug Administration (“FDA”) has approved the Company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the
final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”)
indication to pediatric patients 2 years of age and older.
“We are pleased to announce that BIVIGAM has received FDA approval for treating PI in patients aged 2 years and older. Previously, the indication for BIVIGAM was
restricted to PI patients aged 12 years and older,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This expanded label for BIVIGAM allows ADMA to actively address the treatment needs of younger PI patients earlier in their
treatment journey. In the periods ahead, we look forward to offering BIVIGAM as an FDA-approved treatment option for these pediatric PI patients,” concluded Mr. Grossman.
“We extend our gratitude to the collaborative efforts of the PI disease community, physicians, and the invaluable contribution of the children and families who played a
pivotal role in advancing this clinical program,” said Kaitlin Kestenberg, Senior Vice President, Compliance & Project Operations. “Enrolling and successfully completing these challenging trials is no small feat, and this approval is a
testament to the commendable clinical execution and the dedication of the ADMA team.”
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About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty
plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently 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: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™
(immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its
FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the
manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty 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, 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 and European Patent No. 3375789, among others, related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
About BIVIGAM®
BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May
2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich
syndrome, and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious
infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies. Certain data and other information about BIVIGAM® or ADMA Biologics and its products can be found on the Company’s
website at www.admabiologics.com.
Additional Important Safety Information About BIVIGAM®
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WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
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Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM. Risk factors may include: advanced age, prolonged immobilization,
hypercoagulable conditions, a history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products
in predisposed patients.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer BIVIGAM 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 hyperviscosity.
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BIVIGAM® Contraindications:
History of anaphylactic or severe systemic reactions to human immunoglobulin.
IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
BIVIGAM® Warnings and Precautions:
Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of
blood viscosity for those at risk of hyperviscosity.
IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as
epinephrine available immediately to treat any acute severe hypersensitivity reactions.
Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion.
Hemolytic anemia can develop subsequent to treatment with IGIV products. Monitor patients for hemolysis and hemolytic anemia.
Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the
product and patient for antineutrophil antibodies.
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease
(CJD) agent.
BIVIGAM® Adverse Reactions:
The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood
pressure increased, diarrhea, dizziness, and lethargy.
To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
COMPANY CONTACT:
Skyler Bloom
Senior Director, Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:
Michelle Pappanastos
Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com
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