QUEBEC CITY, July 12, 2011 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the European Patent Office ("EPO") has granted a patent for the use of alkyl phosphocholines, more specifically perifosine (octadecyl 1,1-dimethylpiperidino-4-yl phosphate), in the preparation of a medicament for the treatment of benign and malignant tumours, prior to and/or during the treatment with approved anti-tumour anti-metabolites such as 5FU ("fluorouracil") and capecitabine. Filed on July 29, 2003, the patent (EP #1 545 553) titled, "Use of Alkyl Phosphocholines in Combination with Anti-Tumour Medicaments", will be effective as of July 13, 2011, following its announcement in the European Patent Bulletin, and will expire on July 28, 2023.
Juergen Engel, Ph.D., Aeterna Zentaris President and Chief Executive Officer, commented, "The patent protects the use of perifosine in combination with capecitabine, not only in metastatic colorectal cancer, but also in other cancer indications such as gastric and breast cancer where capecitabine is also approved. The patent comes also at a time when we are looking forward to the completion of the pivotal Phase 3 trials with perifosine in colorectal cancer and multiple myeloma."
The above-mentioned invention has been filed as a counterpart application in several countries, including the U.S. and Canada. The examination procedure of the counterpart applications is still pending or already completed in certain countries. For example, granted patents already exist in Australia, China, Hong Kong, Mexico, New Zealand, Taiwan and Ukraine.
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine, in combination with chemotherapeutic agents, is currently being studied for the treatment of multiple myeloma, colorectal cancer and other cancers, and is the most advanced anticancer agent of its class. Perifosine, as monotherapy, is being explored in other indications. The US Food & Drug Administration ("FDA") has granted perifosine orphan-drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the Phase 3 trials in both of these indications under a Special Protocol Assessment. Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency ("EMA") in multiple myeloma. Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals for North America, Yakult Honsha for Japan and to Handok for Korea.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer. The Company's innovative approach of "personalized medicine" means tailoring treatments to a patient's specific condition and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn from its proprietary discovery unit providing the Company with constant and long-term access to state-of-the-art therapeutic options. For more information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that 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 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, unless required to do so by a governmental authority or by applicable law.
SOURCE AETERNA ZENTARIS INC.