Aeterna Zentaris reaches agreement with FDA for Solorel SPA as a diagnostic test in AGHD

Dec 20 2010

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") today announced that it has reached agreement with the Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for Solorel^® (AEZS-130, macimorelin) which will enable the Company to complete the ongoing registration study required to gain approval as a diagnostic test for Adult Growth Hormone Deficiency (AGHD).

"We are pleased with the agreement with the FDA and now look forward to the completion of the Phase 3 trial with Solorel^® and the NDA filing in 2011 for use as a diagnostic test in AGHD", stated Juergen Engel, Ph.D., President and CEO at Aeterna Zentaris. "In line with our innovative approach, Solorel^® could become the first approved oral test for the diagnosis of AGHD, providing patients with a potentially safer, accurate and more convenient alternative to the current injectable tests."

The study was initiated to compare the performance of Solorel^® against the then-available diagnostic growth hormone releasing hormone (GHRH) Geref Diagnostic^® + Arginine (ARG) standard test. GHRH Geref Diagnostic^® was subsequently withdrawn from the market, worldwide, in 2008. At the time of withdrawal, the trial included 42 patients with AGHD and ten control subjects. In 2009, Aeterna Zentaris regained the rights to Solorel^® and had been working with the FDA to establish the best way forward to complete this registration study and continue to utilize the data obtained thus far, in light of the loss of the original comparator.