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 Maryville, Tennessee. This plasma collection facility
commenced operations and initiated source plasma collection in the
fourth quarter of 2020. With today’s approval, this facility 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
represents both another milestone regulatory achievement as well as
an important step in ADMA’s ambitions to further secure raw
material plasma supply and enhance end-to-end control of
manufacturing operations,” said Adam Grossman, President and Chief
Executive Officer of ADMA. “ADMA has eight plasma collection
facilities under its corporate umbrella, including three
FDA-approved facilities, with five of those facilities now open and
collecting plasma and two additional Biologics License Applications
(“BLA”) filings anticipated over the remainder of 2021. In total,
ADMA remains on track to have 10 or more FDA-approved plasma
collection facilities by 2024. Along with the extension of
third-party supply agreements through year-end 2022, as well as the
anticipated yield enhancements resulting from our recent
implementation of the Haemonetics’ NexSys Persona® technology, ADMA
believes it is insulated from broader market plasma collection and
pricing fluctuations. The Company remains well-positioned to ensure
the continuity of our supply chain and our plasma products
supply.”
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 Persona® plasma
collection system.
New plasma donors can receive $70 on the first
donation and up to $650/month. To learn more about the ADMA
BioCenters donation process, and to schedule an appointment, please
visit: www.admabiocenters.com, or visit in person at: 1412
Sevierville Road, Maryville, Tennessee 37804.
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 “anticipate,” “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 (including,
but not limited to, insulation from any broader market plasma
collection and pricing fluctuations); expansion plans and the goal
of operating ten or more FDA-approved plasma collection centers by
2024; our expectation to file additional BLAs and the timing
thereof; the yield enhancements anticipated to result from the
implementation of Haemonetics’ NexSys Persona® technology; and the
expected staff count at the Maryville facility. 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:Michelle Pappanastos
Senior Managing Director, Argot Partners | 212-600-1902 |
michelle@argotpartners.com
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