ADMA Biologics Receives Unique Permanent J-Code for ASCENIV™
January 26 2021 - 8:00AM
ADMA Biologics, Inc. (Nasdaq: ADMA), an end-to-end commercial
biopharmaceutical company dedicated to manufacturing, marketing and
developing specialty plasma-derived biologics, today announced that
the Centers for Medicare and Medicaid Services (CMS) has issued a
permanent, product-specific J-code for ASCENIV™. Under the
Healthcare Common Procedure Coding System (HCPCS), the J-code
(J1554) will become effective April 1, 2021 and will replace the
currently issued C-code for ASCENIV (C9072), which can continue to
be utilized in the interim for reimbursement purposes. The Company
will retain transitional pass-through status granted for ASCENIV
from CMS.
“The issuance of this product-specific J-code by
CMS for ASCENIV is a significant milestone in the product’s
commercial launch. This J-code will provide for a streamlined and
permanent reimbursement process in all outpatient treatment
settings,” said Adam Grossman, President and Chief Executive
Officer of ADMA. “The J-code implementation will accelerate and
expand patient access to ASCENIV, and as a result, increases our
confidence in the ongoing commercial roll-out, in addition to the
product’s potential contribution to our overall 2024 revenue target
of $250 million or more.”
Permanent J-codes are used by commercial insurers
and government payers to standardize claims submissions and
reimbursements for medications, such as ASCENIV, that are
administered by a healthcare professional in an outpatient setting.
While not a guarantee of payment, these codes enable timely claims
adjudication and processing, and consequently facilitate a
simplified pathway to prescription, administration and ultimately
patient utilization.
About ASCENIV™
ASCENIV (immune globulin intravenous, human – slra
10% liquid) is a plasma-derived, polyclonal, intravenous immune
globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019
and is indicated for the treatment of primary humoral
immunodeficiency (PI), also known as primary immune deficiency
disease (PIDD), in adults and adolescents (12 to 17 years of age).
ASCENIV is manufactured using ADMA’s unique, patented plasma donor
screening methodology and tailored plasma pooling design, which
blends normal source plasma and respiratory syncytial virus (RSV)
plasma obtained from donors tested using the Company’s proprietary
microneutralization assay. ASCENIV contains naturally occurring
polyclonal antibodies, which 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 is
protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.
About ADMA Biologics,
Inc.
ADMA Biologics is an end-to-end American 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 a
portion of 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 related to certain aspects of its products and product
candidates. For more information, please visit
www.admabiologics.com.
Forward-Looking Statements
Any statements contained in this press release that
do not describe historical facts may constitute forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, including statements regarding the anticipated
benefits and expected consequences of the rights plan that ADMA has
adopted. Such statements are identified by use of the words
“anticipates,” “believes,” “estimates,” “expects,” “intends,”
“plans,” “predicts,” “projects,” “should,” and similar expressions.
Any forward-looking statements contained herein are based on
current expectations, but are subject to risks and uncertainties
that could cause actual results to differ materially from those
indicated, including, but not limited to, the effectiveness of the
rights plan in providing the Board of Directors with time to make
informed decisions that are in the best long-term interests of ADMA
and its stockholders, and other risk factors discussed from time to
time in our filings with the SEC, including those factors discussed
under the caption “Risk Factors” in our most recent annual report
on Form 10-K, filed with the SEC on March 13, 2020, and in
subsequent reports filed with or furnished to the SEC. ADMA assumes
no obligation and does not intend to update these forward-looking
statements, except as required by law, to reflect events or
circumstances occurring after today’s date.
COMPANY CONTACT:Skyler
BloomDirector, Investor Relations and Corporate Strategy |
201-478-5552 | sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Sam
MartinManaging Director, Argot Partners | 212-600-1902 |
sam@argotpartners.com
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