Article Excerpt:
TWST: Would you give us an overview of the company?Mr. Gagnon: Aeterna Zentaris is a biopharmaceutical company focused on oncology (cancer) and endocrinology (diseases caused by a hormonal disorder). We have a deep and well-balanced pipeline with some 20 compounds at all stages of development, from drug discovery up to marketing. We currently have two marketed compounds. The first one, CetrotideŽ, is sold worldwide for in vitro fertilization by our pharmaceutical partners, Serono and Shionogi/Nippon Kayaku. The second compound, ImpavidoŽ, is sold for the treatment of black fever, a parasitic disease which affects about 12 million people, mostly in developing countries. If not treated, the disease may prove lethal. As far as compounds in clinical development (trials involving humans), three represent our main value drivers: cetrorelix, ozarelix, and perifosine. These compounds have reached late stages (Phase II and Phase III) of clinical development. Cetrorelix has yielded positive Phase II results in endometriosis, a benign condition consisting of tissue growth outside the uterus, and in benign prostatic hyperplasia (BPH), a benign enlargement of the prostate causing urinary problems for almost 50% of older men. We are now in the process of initiating our own Phase III trial in BPH in the United States after successful meetings with the FDA in June, while our partner Solvay is currently developing a late-stage clinical program in endometriosis in Europe. Our second value-driver, ozarelix is being developed also in BPH as well as in prostate cancer. In August, we were very pleased to announce positive Phase II results in prostate cancer which allows us to push ahead with a more advanced- stage clinical trial in this same indication with ozarelix. We should also be announcing Phase II trial results in BPH with ozarelix shortly, which would lead to further clinical trials in BPH. Also in August, we entered into a licensing and collaboration agreement for ozarelix with Nippon Kayaku, already a strong partner of ours and a key player in the Japanese oncology market. We granted Nippon Kayaku an exclusive license to develop and commercialize ozarelix for all potential oncology indications in Japan. In return, we will receive an upfront payment, and are eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to low double-digit royalties on potential net sales. The agreement with Nippon Kayaku not only strengthens our financial position, but, most important, further validates the potential of ozarelix. Let me turn now to our third value driver, perifosine, which is being developed in Phase II trials in the US and Europe, mostly for the treatment of prostate, lung and breast cancer. By year-end, we should announce completion of patient recruitment for a Phase II trial in non-small cell lung cancer where perifosine is being given with radiotherapy. When you look at the market opportunities for these compounds, they are quite significant. Endometriosis represents a market of close to $2 billion, BPH close to $2.6 billion while prostate cancer and non-small cell lung cancer are markets representing about $3 billion. The real value of our company lies in our innovative products, our scientific know-how to develop them and our ability to bring them to market. We have people with extensive experience in drug development and a management team composed of seasoned executives from the pharmaceutical industry, who have taken products from the laboratory to market. So we feel we have a strong team that will enable us to grow our business and build value over the next few years.
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