Adamis Pharmaceuticals Receives Notice of Allowance for US and Japanese Patents for Its Dry Powder Inhaler
28 Enero 2015 - 8:00AM
Adamis Pharmaceuticals Corporation (Nasdaq:ADMP) ("Company")
recently received a notice of allowance that one of its patent
applications for its proprietary dry powder inhaler, Taper DPI,
will issue in the United States (U.S. Patent Application No.
13/320,762) and in Japan (Japanese Patent Application No.
2012-511965). The approved claims describe the device and
components that are important for its function.
As previously announced, Adamis acquired worldwide rights to the
Taper DPI technology in all medical indications from 3M. The
Taper DPI technology was designed to efficiently deliver dry powder
by utilizing a carrier tape. Adamis intends to use the Taper
DPI initially to develop a combination drug product, referred to as
APC-5000 DPI, intended for the treatment of asthma and COPD by
delivering the same active ingredients as GlaxoSmithKline's ("GSK")
Advair Diskus®. The Advair Diskus®, which, according to GSK's
public filings, had revenues of over $8 billion worldwide in 2013,
is a dry powder inhaler product that combines fluticasone and
salmeterol. Fluticasone belongs to the family of medicines
known as corticosteroids or steroids which produce
anti-inflammatory effects. Salmeterol is a long-acting beta-agonist
drug that causes bronchodilation by relaxing the smooth muscle in
the airway.
In its current stage of development, Adamis' Taper DPI combines
patient-friendly design and active aerosolization to provide
effective delivery of drug in a multi-dose DPI. Additional
advantages of the current technology seem to include: greater
efficiency, ability to supply a single or combination of drugs,
eliminates the need for excipients in most formulations, less
dependence on the individual's inspiratory flow rate, and ease of
use.
Upon completion of clinical trials and if required regulatory
approvals are obtained, Adamis intends to commercially market the
APC-5000 product to compete for a share of the Advair Diskus®
market with a branded generic version. Assuming clinical
trials are successfully completed, Adamis expects to pursue an NDA
under Section 505(b)(2) to seek approval for sale in the U.S.
market. Outside of the U.S., the Company plans to identify
potential opportunities to market APC-5000 DPI based
products. The Company also believes that the device can be
used to deliver a variety of different drug compounds, potentially
creating multiple follow-on products for Adamis using this platform
DPI technology.
About Adamis Pharmaceuticals Corporation
Adamis Pharmaceuticals Corporation is a biopharmaceutical
company engaged in the development and commercialization of
specialty pharmaceutical and biotechnology products in the
therapeutic areas of respiratory disease, allergy, oncology and
immunology. Adamis' 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-3000, an HFA inhaled nasal steroid
product for the treatment of allergic rhinitis. The company's
vaccine product candidates and cancer drug product candidates under
research and development include TeloB-VAX, a cell-based
therapeutic cancer vaccine and three drugs, APC-100, APC-200, and
APC-300, for the treatment of prostate cancer.
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 or future financial performance, including,
but not limited to the following statements: 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. 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. The company does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this press release.
CONTACT: Mark Flather
Director, Investor Relations
& Corporate Communications
(858) 412-7951
mflather@adamispharma.com
Mark Gundy
External Investor Relations
972-240-1873
markgundy@gmail.com
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