ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collecti...
March 03 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 its plasma collection center located in Kennesaw,
Georgia received approval from the Korean Ministry of Food and Drug
Safety (MFDS) for the sale of source plasma into South Korea. In
conjunction with the South Korean approval, ADMA additionally
announced the Kennesaw plasma collection center received FDA
approval to implement a Hepatitis B immunization program, enabling
ADMA to collect source plasma from donors immunized with an
FDA-licensed Hepatitis B vaccine.
“These approvals demonstrate ADMA’s strict adherence to the
regulatory requirements of the global plasma community and build
upon the significant regulatory milestones already achieved by our
Company in 2021,” said Adam Grossman, President and Chief Executive
Officer of ADMA Biologics. “The approvals announced today further
enhance our existing global presence as a source plasma provider,
which includes the United States and now South Korea. Our
BioCenters expansion strategy remains comfortably on track, and
these approvals represent another important step towards our
objective of further securing our raw material supply chain and
enhancing our end-to-end control of manufacturing operations.”
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
objective of further securing its raw material supply chain and
enhancing its end-to-end control of manufacturing operations.
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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