ADMA Biologics Opens Newest ADMA BioCenters Plasma Collection Facility in Maryville, TN
December 01 2020 - 7:00AM
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 commencement of operations and initiation of collections
at its newest ADMA BioCenters plasma collection facility located in
Maryville, Tennessee. ADMA also announced the submission of a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) seeking approval for this third plasma
collection center.
“We believe the rapid expansion of our ADMA BioCenters plasma
collections facilities demonstrates the Company’s focus on ensuring
essential raw material supply chain continuity and control into the
future,” said Adam Grossman, President and Chief Executive Officer
of ADMA. “The opening of the Maryville, TN facility will allow us
to continue to increase plasma collection throughput into 2021 and
beyond, thereby ensuring the Company’s ability to self-supply a
portion of its needs in order to continue to execute on top-line
revenue growth. In the face of COVID-19 headwinds, we currently
remain on track to achieve the Company’s stated goal of opening
five to ten new plasma collection centers over the next three to
five years, and ultimately progressing towards our goal of
solidifying a fully vertically integrated and essentially
self-sufficient supply chain.”
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.
The FDA regulatory process for obtaining approval for this
plasma collection center includes a site inspection and an
approximately 12-month BLA review period. As such, ADMA expects to
receive an approval decision for this third plasma facility in the
fourth quarter of 2021. In the meantime, ADMA is permitted to
collect plasma donations at this site, and once FDA approved, it
can use the plasma collected for production of its FDA approved
immunoglobulin products.
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 five to ten new plasma collection
centers over the next three to five years; our expectation to
receive an FDA approval decision to our filed BLA and the timing
thereof; and the use of plasma collected at the Maryville facility
for production of immunoglobulin products. 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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