Amphastar Announces Approval for Glucagon for Injection Kit, 1mg
December 29 2020 - 6:00AM
Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced that
the U.S. Food and Drug Administration (“FDA”) has
approved its Abbreviated New Drug Application (“ANDA”) for Glucagon
for Injection Emergency Kit, 1 mg. Glucagon is indicated for the
treatment of severe hypoglycemia and is also used as a diagnostic
aid. Amphastar’s newly approved synthetic peptide product was
determined by the FDA to be bioequivalent and
therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit
for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.
Amphastar's CEO and President, Dr. Jack Zhang, commented:
"This approval is yet another milestone for the Company and marks
the first-ever FDA approval of a generic version of rDNA Glucagon.
Using a dedicated process and sophisticated characterization
technology, we demonstrated to the Agency that our highly purified
synthetic peptide product is bioequivalent and therapeutically
equivalent to the reference listed drug (RLD), which is an rDNA
product. This further highlights Amphastar’s considerable abilities
to bring complex generic drugs to the market, and more
specifically, our strong peptide capabilities."
According to IQVIA, the U.S. sales for Eli Lilly’s Glucagon
Emergency Kit for Low Blood Sugar, 1 mg, were
approximately $144 million, and the overall U.S. sales of
brand products containing glucagon for injection, 1 mg, were
approximately $306 million for the 12 months ended September
30, 2020.
Amphastar plans to launch this Glucagon for Injection Emergency
Kit, which it previously referred to as AMP-001, within two
months.
Pipeline Information
The Company currently has four ANDAs filed with the FDA,
which are targeting products with a market size of approximately
$1.4 billion, three biosimilar products in development targeting
products with a market size of approximately $13.0 billion,
and nine generic products in development targeting products with a
market size of approximately $12.0 billion. This market
information is based on IQVIA data for the 12 months
ended September 30, 2020. The Company is developing multiple
proprietary pipeline products for injectable and intranasal dosage
forms, including a new drug application for intranasal naloxone and
intranasal epinephrine.
Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug
Master Files, or DMF, on file with the FDA and is developing
several additional DMFs.
Company Information
Amphastar is a specialty pharmaceutical company that focuses
primarily on developing, manufacturing, marketing, and selling
technically-challenging generic and proprietary injectable,
inhalation, and intranasal products. Additionally, the Company
sells insulin API products. Most of the Company’s finished
products are used in hospital or urgent care clinical settings and
are primarily contracted and distributed through group purchasing
organizations and drug wholesalers. More information and
resources are available at www.amphastar.com.
Amphastar’s logo and other trademarks or service marks of
Amphastar, including, but not limited to Amphastar®, Primatene
MIST®, Amphadase®, and Cortrosyn®, are the property of
Amphastar.
Forward-Looking Statements
All statements in this press release that are not historical are
forward-looking statements, including, among other things,
statements relating to the Company’s expectations regarding future
financial performance, backlog, sales and marketing of its
products, market size and growth, the timing of FDA filings or
approvals, including the DMFs of ANP, the timing of product
launches, acquisitions and other matters related to its pipeline of
product candidates, its share buyback program and other future
events. These statements are not historical facts but rather are
based on Amphastar’s historical performance and its current
expectations, estimates, and projections regarding Amphastar’s
business, operations, and other similar or related factors. Words
such as “may,” “might,” “will,” “could,” “would,” “should,”
“anticipate,” “predict,” “potential,” “continue,” “expect,”
“intend,” “plan,” “project,” “believe,” “estimate,” and other
similar or related expressions are used to identify these
forward-looking statements. However, not all forward-looking
statements contain these words. You should not place undue reliance
on forward-looking statements because they involve known and
unknown risks, uncertainties, and assumptions that are difficult or
impossible to predict and, in some cases, beyond Amphastar’s
control. Actual results may differ materially from those in
the forward-looking statements as a result of a number of factors,
including those described in Amphastar’s filings with
the Securities and Exchange Commission. You can locate these
reports through the Company’s website
at http://ir.amphastar.com and on the SEC’s website
at www.sec.gov. Amphastar undertakes no obligation to
revise or update information in this press release to reflect
events or circumstances in the future, even if new information
becomes available or if subsequent events cause Amphastar’s
expectations to change.
Noted products are trademarks or registered trademarks of their
respective owners.
Contact Information: Amphastar Pharmaceuticals, Inc.Bill
PetersChief Financial Officer(909) 980-9484
Source: Amphastar Pharmaceuticals, Inc.
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