QUEBEC CITY, March 1 /PRNewswire-FirstCall/ - Æterna Zentaris Inc. (NASDAQ: AEZS, TSX:AEZ) (the “Company”), a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received a positive opinion for orphan medicinal product designation for its compound perifosine from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of multiple myeloma. Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX - News), Æterna Zentaris’ partner and licensee for perifosine in the North American market, already announced in September 2009 that it has received Orphan Drug Designation for perifosine for the treatment of multiple myeloma from the U.S. Food and Drug Administration (FDA).
Juergen Engel, Ph. D., President and CEO of Æterna Zentaris stated, “We are very pleased with the positive opinion which is summarized by the COMP as follows: ‘The preclinical data and the preliminary clinical data obtained with perifosine justifies the claim on a clinically relevant advantage based in particular on the response obtained in relapsed and refractory multiple myeloma patients. Furthermore, perifosine is intended for oral administration, compared to the currently available parenteral treatments. This supports the assumption for a major contribution to patient care with regards to convenience and avoidance of a more aggressive administration route.’”
About Orphan Medicinal Product Designation
Orphan medicinal product designation is granted by the European Commission, following a positive opinion from the COMP, to a medicinal product that is intended for the diagnosis, prevention or treatment of a life-threatening or a chronically debilitating condition affecting not more than five in 10,000 persons in the Community when the application for designation is submitted.
Orphan medicinal product designation provides the sponsor with access to the Centralized Procedure for the application for marketing authorization, protocol assistance, up to a 100% reduction in fees related to a marketing authorization application, pre-authorization inspection and post-authorization activities, and could provide ten years of market exclusivity in EU, once approved for the treatment of multiple myeloma.
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths.
According to the International Myeloma Foundation, more than 85,000 men and women in Europe were currently undergoing treatment for multiple myeloma in 2007 and 25,000 people were expecting to die from multiple myeloma in 2007. According to the American Cancer Society, an estimated 20,580 new cases of multiple myeloma were diagnosed in the United States and 10,500 people were expecting to die from multiple myeloma in the United States in 2009.
To date, several authorized therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.
About Perifosine
Perifosine is a novel oral anti-cancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. A Phase 3 study in multiple myeloma, under Special Protocol Assessment (SPA) and Fast-track review, was initiated in December 2009 in the U.S. and recruitment for a Phase 3 trial, also under SPA, in refractory metastatic colorectal cancer should be started in Q2-2010 in the U.S. Perifosine is currently also in Phase 2 clinical development for multiple tumor types.
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrinology. News releases and additional information are available at www.aezsinc.com
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments except if we are required by a governmental authority or applicable law.
