Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE

MONMOUTH JUNCTION, N.J., June 25 /PRNewswire/ -- Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation, has provided a $2.2 million award to Transave Inc., for the continued development of ARIKACE(TM) (liposomal amikacin for inhalation), an antibiotic that aims to treat Pseudomonas lung infections in cystic fibrosis (CF) and non-CF bronchiectasis patients. Transave announced today that the award will be used to support an ongoing Phase II clinical trial in U.S. CF patients with Pseudomonas lung infections and a preclinical study. The company also reported today completion of enrollment for its second CF Phase II clinical trial; results are expected to be available in July. The first CF Phase II trial, completed in June 2008, achieved positive results.

In other developments, the company announced that it was granted a patent for ARIKACE by the U.S. Patent and Trademark Office. U.S. Patent No. 7,544,369 entitled "Sustained Release of Antiinfectives" covers ARIKACE for the once-daily treatment of Pseudomonas lung infections.

"We have followed and supported Transave's work in this area from the beginning, and we are excited to play a role in potentially bringing another new treatment option to CF patients," said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. "The potential for ARIKACE is encouraging, both in terms of possible lung function improvements and quality of life outcomes."

Under the terms of the agreement, Transave stands to receive $2.2 million upon achievement of certain milestones. Cystic Fibrosis Foundation Therapeutics provided a previous award of $1.7 million to support the development of ARIKACE.

"We believe ARIKACE -- a once-a-day treatment with sustained effect -- can be a real breakthrough in CF patients' arduous treatment burden , and are looking forward to seeing the Phase II results and moving to Phase III soon afterward," said Tim Whitten, Transave's President and Chief Executive Officer. "We are grateful for the continued support of the CF Foundation as we strive to improve treatment options for CF patients."

The double-blind, 3 cohort, placebo-controlled study is designed to evaluate ARIKACE in the treatment of CF patients with Pseudomonas lung infections. A total of 46 patients have been randomized. ARIKACE or placebo are administered once daily for 28 days using an eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Eighteen clinical sites throughout the United States are participating in the study.