Transave Inc. recently announced the US Patent and Trademark Office has issued an important composition of matter patent (US 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 CEO. "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 III as soon as possible."

The company also announced that the US Patent office granted another patent (US 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 lipids (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 II clinical trials in the treatment of CF patients with Pseudomonas lung infections. The company also previously announced positive Phase II 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 US 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.  

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.