INNOVIVE'S LEUKEMIA DRUG RECEIVES ORPHAN DRUG DESIGNATION

Innovive Pharmaceuticals has announced that the FDA has granted orphan drug designation to the company's Phase I drug candidate INNO-406, an orally bioavailable dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec-resistant or intolerant chronic myelogenous leukemia.

Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions that affect fewer than 200,000 Americans a year, according to Innovive. Developers of orphan drugs are granted seven years of marketing exclusivity after approval of their orphan drug product as well as tax incentives for clinical research they have undertaken. In addition, the FDA coordinates research study design assistance for developers of drugs for rare diseases and conditions, and grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan drug products.

Innovive reported preliminary data from a Phase I study of INNO-406 during the American Society of Hematology Annual Meeting in December 2006 showing that early evidence of clinical activity has been demonstrated in Gleevec-resistant and nilotinib-intolerant patients using hematologic, cytogenetic and molecular measures. Therapeutically active concentrations of INNO-406 have been achieved in human tissue, and the drug has been shown to be safe through the first three dose cohorts with no serious adverse events or clinically relevant adverse events reported. INNO-406 is well tolerated at 120 mg/day and the dose-escalating Phase I study continues in an effort to determine a recommended Phase II dose. The company plans to announce final data from the Phase I study in the second quarter of 2007 and initiate a Phase II pivotal trial in 2007.