Adamis Pharmaceuticals Announces FDA Acceptance of Resubmission of Its Epinephrine Pre-Filled Syringe NDA
19 Enero 2017 - 8:00AM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Company” or
“Adamis”) today announced that the U.S. Food and Drug
Administration (“FDA”) has accepted for review the Company’s New
Drug Application (“NDA”) for its Epinephrine Pre-filled Syringe
(“PFS”) product candidate for the emergency treatment of
anaphylaxis. Filed on December 15, 2016, the resubmission was
intended to address the issues raised by the FDA in the agency’s
June 2016 Complete Response Letter (“CRL”). The FDA indicated
that it considered the resubmission to be a complete response to
the CRL.
About the Product
Adamis’ EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled
single dose syringe) (PFS) was designed as a lower cost alternative
to market leading auto-injectors. Adamis’ PFS provides a
single-dose of epinephrine, which is considered the drug of choice
for immediate administration in acute anaphylactic reactions to
insect stings or bites, foods (such as nuts), drugs and other
allergens, as well as idiopathic or exercised-induced
anaphylaxis.
About Anaphylaxis
Anaphylaxis is a serious, sometimes life-threatening allergic
reaction. The most common anaphylactic reactions are to foods,
insect stings, medications and latex. According to information
published by industry sources reporting on findings from a
2009-2010 study, up to 8% of U.S. children under the age of 18 have
a food allergy, and approximately 38% of those with a food allergy
have a history of severe reactions. Anaphylaxis requires
immediately medical treatment, including an injection of
epinephrine. The number of prescriptions for epinephrine
products has grown annually, as the risk of anaphylaxis has become
more widely understood. Based on industry data, Adamis
estimates that sales of prescription epinephrine products in 2015
were approximately $1.2 billion.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty
biopharmaceutical company focused on developing and commercializing
products in the therapeutic areas of respiratory disease and
allergy. The Company’s current specialty pharmaceutical
product candidates include the Epinephrine Injection PFS syringe
product for use in the emergency treatment of anaphylaxis, APC-1000
and APC-5000 for the treatment of asthma and chronic obstructive
pulmonary disease, and APC-2000 for the treatment of
bronchospasms. The Company’s U.S. Compounding, Inc.
subsidiary, which is registered as a drug compounding outsourcing
facility under Section 503B of the U.S. Food, Drug & Cosmetic
Act and the U.S. Drug Quality and Security Act, provides
prescription compounded medications, including compounded sterile
preparations and non-sterile compounds, to patients, physician
clinics, hospitals, surgery centers and other clients throughout
most of the United States. USC’s product offerings broadly
include, among others, corticosteroids, hormone replacement
therapies, hospital outsourcing products, injectables, urological
preparations, ophthalmic preparations, topical compounds for pain
and men’s and women’s health products.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to future events or our future
results of operations, including, but not limited to the following
statements: the company’s beliefs concerning the timing and outcome
of the FDA’s review of the company’s NDA relating to its
Epinephrine PFS product candidate and the company’s ability to
satisfactorily respond to the matters raised in the FDA’s Complete
Response Letter relating to the Epinephrine PFS product; the
company's beliefs concerning the ability of its product candidates
to compete successfully in the market; the company's beliefs
concerning the safety and effectiveness of its product candidates;
the results of any future clinical trials that the company may
conduct relating to its product candidates; the ability to fund
future product development; future revenues expected from any of
its product candidates, assuming that they are developed and
approved for marketing by the FDA and other regulatory authorities;
and the intellectual property protection that may be afforded by
any patents or patent applications relating to its products and
product candidates. Statements in this press release
concerning future events depend on several factors beyond the
company's control, including receipt of adequate funding to support
these activities, the absence of unexpected developments or delays,
market conditions, and the regulatory approval process. These
statements are only predictions and involve known and unknown
risks, uncertainties and other factors, which may cause Adamis'
actual results to be materially different from these
forward-looking statements. There can be no assurances that
the company will successfully complete development of the PFS
product candidate, that the FDA will approve the NDA following
resubmission of the NDA by the company, or that the product will be
commercially successful if introduced. The company will
require additional funding to commercially launch the
product. Certain of these risks, uncertainties, and other
factors are described in greater detail in Adamis' filings from
time to time with the SEC, which Adamis strongly urges you to read
and consider, all of which are available free of charge on the
SEC's web site at http://www.sec.gov. Except to the
extent required by law, Adamis expressly disclaims any obligation
to update any forward-looking statements.
Contact Adamis
Mark Flather
Senior Director, Investor Relations
& Corporate Communications
(858) 412-7951
mflather@adamispharma.com
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