Thursday, January 29, 2015
Adamis Pharmaceuticals Corporation 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.
Source : http://globenewswire.com/
