SAN DIEGO, Aug. 03, 2016 — 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. 14/622,617). The approved claims describe the device and components that are important for its drug delivery functions.
In addition, the Company was recently granted a European patent for one of its patent applications for its proprietary dry powder inhaler, Taper DPI (European Patent EP1996173 “Powder Filling Processes”). Adamis’ Taper DPI uses 3M’s proprietary microcarrier tape technology to carry drug product and the approved claims describe processes important for the filling of drug product onto the carrier tape. Both patents strengthen the Company’s intellectual property portfolio surrounding the Taper DPI platform technology.
The 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. Adamis is using the Taper DPI initially to develop a combination drug product, referred to as APC-5000, 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 $5.5 billion worldwide in 2015, is a dry powder inhaler product that combines fluticasone and salmeterol with an excipient (lactose). 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.
Adamis has previously announced positive pharmacokinetic study results for APC-5000 which uses less amount of drug loaded into the device in comparison to the Advair Diskus® thereby reducing the amount of drug given to the patient while still maintaining the same theoretical therapeutic dose. The study results confirmed that systemic exposure to the drugs fluticasone and salmeterol was reduced after treatment with APC-5000, as compared to Advair® Diskus®, thereby potentially increasing the overall safety of the product.
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. The company has already begun process development for the dry powder inhaler device and intends to have enough devices manufactured in order for APC-5000 to be phase III ready in 2017.
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 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 Adamis Mark Flather Senior Director, Investor Relations & Corporate Communications (858) 412-7951 email@example.com