Aradigm Corporation (OTCBB: ARDM) (“Aradigm” or the "Company") today announced that the United States Patent and Trademark Office has issued an important method of treatment patent (U.S. Patent No. 8,256,433) covering Systems and Methods for Effecting Cessation of Tobacco Use. The Company expects that the patent will provide exclusivity for specific systems utilizing inhaled nicotine formulations until January 7, 2024.
“Tobacco smoking remains an enormous healthcare problem in the U.S. which we believe is entirely preventable,” said Igor Gonda, Aradigm’s President and CEO. “The craving for cigarettes has been documented to be a key factor causing the high failure rate of currently approved pharmaceutical approaches to smoking cessation. Several key opinion leaders believe that the ideal smoking cessation tool should emulate the delivery of nicotine by cigarettes – i.e., a true lung delivery that provides a very rapid uptake of nicotine into the arterial blood similar to that resulting from smoking cigarettes. Aradigm has developed the AERX™ Nicotine Inhaler, an inhalation system which addresses this critical product attribute and, in contrast to cigarettes, delivers pure nicotine dissolved in water.”
Aradigm has two issued U.S. patents, 6,799,576 and 6,874,507 covering systems for effecting smoking cessation, which provide exclusivity until 2019. This newly issued patent is from a second patent family and provides protection until at least 2024, greatly extending the duration of protection. The first two patents are method of treatment patents, covering systems, devices and containers for delivering aerosolized nicotine formulations in specific ways which the Company believes to be important for cigarette smokers who want to quit smoking. This new patent extends the coverage to containers with novel features anticipated to provide additional smoking cessation benefits.
About the AERx Nicotine Inhaler for Smoking Cessation
Aradigm’s palm-size AERx Nicotine Inhaler generates a fine nicotine mist from a solution of pure nicotine salt dissolved in a small amount of water. No heating is used and there is no “secondhand smoke” as the user takes a single deep inhalation from the inhaler, rather than “puffing” on it. Phase I clinical results in smokers from the Company’s inhaled nicotine product candidate demonstrate cigarette-like nicotine concentrations with nearly instantaneous high plasma levels of nicotine and a rapid and lasting reduction in the craving for cigarettes.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. The Company has product candidates addressing the treatment of bronchiectasis, cystic fibrosis, inhalation tularemia and anthrax infections, and smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the timing and results of future clinical trials and treatment effectiveness of the Company’s formulations, as well as the other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on March 28, 2012, and the Company’s Quarterly Reports on Form 10-Q.
Aradigm, AERx and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Nancy Pecota, 510-265-8800
Chief Financial Officer
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