FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Apr 5 2010

Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals (Nasdaq: KERX), was granted Fast Track designation by the U.S. Food and Drug Administration ("FDA") for perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of refractory advanced colorectal cancer. Keryx is Æterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Æterna Zentaris has also out-licensed perifosine to Handok in South Korea while retaining rights for the rest of the world.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda(R)) versus placebo in combination with capecitabine (Xeloda(R)) in patients with refractory metastatic colorectal cancer is expected to commence this quarter under a Special Protocol Assessment (SPA) with the FDA.

Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna Zentaris, commented, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012. These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."

In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under a SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted. This trial is also sponsored by our partner, Keryx.

Furthermore, the Company received a positive opinion for Orphan Medicinal Product Designation for perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency for the treatment of multiple myeloma.