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 fourth ADMA BioCenters plasma collection
facility located in Goose Creek, South Carolina. In conjunction,
the facility was issued a compliance certification from the
International Quality Plasma Program (“IQPP”), confirming the
center meets facility and donor criteria for IQPP Certification.
This plasma collection facility commenced operations and initiated
source plasma collection in the second quarter of 2021. 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.
“ADMA is off to an excellent start to 2022 across its business
segments, and the approval of the Goose Creek plasma collection
center represents another regulatory milestone achievement as well
as an important step in ADMA’s ambitions to further secure raw
material plasma supply,” said Adam Grossman, President and Chief
Executive Officer of ADMA.
“ADMA now has four FDA-approved plasma collection centers, two
additional centers operational and collecting plasma, and three
additional centers in the planning and construction phases. The
successful execution by our BioCenters team positions ADMA to meet
or exceed the Company’s target of having 10 or more plasma
collection centers FDA-licensed by year-end 2023,” said Brian Lenz,
Executive Vice President, Chief Financial Officer, and General
Manager, ADMA BioCenters.
“ADMA remains on track towards growing its plasma supply, a
commitment that is underpinned by the collective benefits of
contractually committed third-party supply agreements, yield
enhancements being realized from the implementation of the
Haemonetics’ NexSys Persona®, and the aggressive BioCenters
expansion strategy. With broader industry plasma collection
headwinds anticipated to persist in early 2022 due to COVID-19 and
other factors, ADMA believes its uniquely strong plasma supply
position will support the continued acquisition of new customers in
the in the supply-constrained U.S. immunoglobulin market. We thank
the FDA for its efforts and expeditious review of the Goose Creek
Biologics License Application (“BLA”), which came well in advance
of the agency’s targeted approval date,” concluded Mr. Lenz.
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.
To learn more about the ADMA BioCenters donation process, and to
schedule an appointment, please visit: www.admabiocenters.com,
or visit in person at: 214 Saint James Avenue, Goose Creek, S.C.
29445.
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 and European Patent No. 3375789 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. and its subsidiaries (collectively, “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 year-end 2023; the Company’s plasma
supply; our expectation to file additional BLAs and the timing
thereof; the yield enhancements anticipated to result from the
implementation of Haemonetics’ NexSys Persona® technology; the
Company’s growing customer base as a result of its strong plasma
supply position; and the expected staff count at the Goose Creek
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 BloomSenior Director,
Corporate Strategy and Business Development | 201-478-5552 |
sbloom@admabio.com
INVESTOR RELATIONS CONTACT:Michelle
PappanastosSenior Managing Director, Argot Partners | 212-600-1902
| michelle@argotpartners.com
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