MONMOUTH JUNCTION, N.J., May 24 /PRNewswire/ -- Transave Inc. today announced that the United States Patent and Trademark Office has issued an important composition of matter patent (U.S. Patent No. 7,718,189) for liposomal aminoglycoside formulations including its lead compound, ARIKACE™ (liposomal amikacin for inhalation). The company expects that the patent will provide exclusivity for ARIKACE until October 1, 2026.
"The issuance of this composition of matter patent significantly strengthens the intellectual property estate around ARIKACE and represents a valuable asset for Transave," said Tim Whitten, Transave's chief executive officer. "We are continuing to secure and expand our proprietary position for ARIKACE which has the potential to become an important treatment for cystic fibrosis (CF) patients with Pseudomonas lung infections, non-CF bronchiectasis patients with Pseudomonas lung infections, and patients with nontuberculous mycobacteria (NTM) lung infections. We look forward to moving to Phase 3 as soon as possible."
The company also announced that the U.S. Patent office granted another patent (U.S. Patent No. 7,544,369) last year covering ARIKACE for the sustained release of antibiotic and once-daily treatment of Pseudomonas lung infections.
ARIKACE is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm. ARIKACE is administered once daily using a customized Investigational eFlow® Nebulizer System (PARI Pharma GmbH), a novel, highly efficient and portable aerosol delivery system enabling more effective distribution in the lungs.
Positive results were announced in October 2009 from pooled results of two Phase 2 clinical trials in the treatment of CF patients with Pseudomonas lung infections. The company also previously announced positive Phase 2 results in September 2009 in the treatment of non-CF bronchiectasis patients who have Pseudomonas lung infections.
ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF. ARIKACE has also been granted orphan drug status by the FDA for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.
About the Investigational eFlow® Nebulizer System and PARI Pharma
ARIKACE is delivered by an Investigational eFlow® Nebulizer System developed by PARI Pharma and optimized specifically for ARIKACE. The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes. Compared to other nebulization technologies, eFlow Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its quiet mode of operation, small size (it fits in the palm of the patient's hand), light weight, and battery use, eFlow Technology reduces the burden of taking daily, inhaled treatments. PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Online at www.paripharma.com.
About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company's major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave's technology and development programs, visit www.transaveinc.com.