SQUALAMINE FOR AMD SELECTED INTO FDA'S CONTINUOUS MARKETING APPLICATION PILOT 2 PROGRAM

Genaera has announced that the FDA has selected squalamine for participation in the continuous marketing application (CMA) Pilot 2 program.

Genaera is developing squalamine for the treatment of "wet" age-related macular degeneration (AMD). Participation in the Pilot 2 program is limited to no more than one fast-track product for each review division within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research. Squalamine is the product selected by CDER's Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products.

Squalamine is a systemically administered anti-angiogenic small molecule. Genaera is currently conducting three Phase II trials of squalamine in AMD at multiple sites throughout the U.S. In October 2004, the FDA granted squalamine fast-track designation.

The CMA Pilot 2 program provides for frequent scientific feedback and interactions during the investigational new drug phase of new drug development based on a defined agreement between the FDA and the applicant. The FDA initiated the CMA Pilot 2 program to evaluate the costs and benefits of increased sponsor access to guidance and feedback from the FDA for fast-track products.