ADMA Biologics Receives FDA Approval for ADMA BioCenters Plasma Collection Facility in Knoxville, TN
February 01 2021 - 8:00AM
ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end
commercial biopharmaceutical company dedicated to manufacturing,
marketing and developing specialty plasma-derived biologics, today
announced that it has received U.S. Food and Drug Administration
(“FDA”) approval for its ADMA BioCenters plasma collection facility
located in Knoxville, Tennessee. This plasma collection facility
commenced operations and initiated source plasma collection in the
third quarter of 2020, and with today’s approval, it is now FDA
licensed to collect and introduce into interstate commerce human
source plasma for further manufacturing in the U.S.
“The approval of this plasma collection facility was received
well-ahead of the scheduled FDA goal date. This milestone
represents yet another example of the Company’s continued
progression towards achieving its objective of further securing its
raw material supply chain and enhancing our end-to-end control of
manufacturing operations,” said Adam Grossman, President and Chief
Executive Officer of ADMA. “With the Knoxville approval, we remain
comfortably on track to achieve our goal of building out up to 10
plasma collection centers by 2024, including the potential approval
of our plasma collection facility located in Maryville, Tennessee
in the second half of this year, as well as the filing of Biologics
License Applications (“BLAs”) for an additional two plasma
collection centers. 2021 is off to an excellent start for our
Company and today’s approval is the first in what we expect to be a
series of value-creating FDA decisions during the year across all
business segments. These achievements are expected to enhance the
supply chain, increase product yields and improve margins for our
revenue generating products as we continue towards
profitability.”
This new, state-of-the-art plasma collection center features
automated registration, high-tech collection equipment designed to
shorten the donation process, free Wi-Fi wireless network in the
donor collection area, individual flat-screen TVs with cable at
each donor station, and highly trained and certified staff who put
donor comfort and safety first. At full capacity, the plasma center
expects to maintain a staff of 50 highly trained healthcare
workers. This center is approved to use the state-of-the-art
Haemonetics NexSys plasma collection system.
About ADMA BioCenters
ADMA BioCenters is an FDA licensed facility specializing in the
collection of human plasma used to make special medications for the
treatment and prevention of diseases. Managed by a team of experts
who have decades of experience in the specialized field of plasma
collection, ADMA BioCenters provides a safe, professional and
pleasant donation environment. ADMA BioCenters strictly follows FDA
regulations and guidance and enforces cGMP (current good
manufacturing practices) in all of its facilities. For more
information about ADMA BioCenters, please visit
www.admabiocenters.com.
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 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.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains “forward-looking statements”
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,”
“our” or the “Company”). Forward-looking statements include,
without limitation, any statement that may predict, forecast,
indicate, or imply future results, performance or achievements, and
may contain such words as “intend,” “target,” “plan,” “expect,”
“believe,” “will,” “is likely,” “will likely,” “should,” “could,”
“would,” “may,” or, in each case, their negative, or words or
expressions of similar meaning. These forward-looking statements
also include, but are not limited to, statements about ADMA’s
future results of operations; expansion plans and the goal of
opening up to ten new plasma collection centers by 2024; our
expectation to receive an FDA approval for our Maryville, Tennessee
plasma collection center and the timing thereof; our expectation to
file additional BLAs; and the receipt of additional FDA approvals
during 2021 and the effects on our business of such approvals.
Actual events or results may differ materially from those described
in this document due to a number of important factors. Current and
prospective security holders are cautioned that there also can be
no assurance that the forward-looking statements included in this
press release will prove to be accurate. Except to the extent
required by applicable laws or rules, ADMA does not undertake any
obligation to update any forward-looking statements or to announce
revisions to any of the forward-looking statements. Forward-looking
statements are subject to many risks, uncertainties and other
factors that could cause our actual results, and the timing of
certain events, to differ materially from any future results
expressed or implied by the forward-looking statements, including,
but not limited to, the risks and uncertainties described in our
filings with the U.S. Securities and Exchange Commission, including
our most recent reports on Form 10-K, 10-Q and 8-K, and any
amendments thereto.
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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