Dr. Engel: AEterna Zentaris is a late-stage drug development company specialized in oncology and endocrinology, with a robust and balanced pipeline. We have projects in late-stage drug development and early-stage drug development, and we also have our own drug discovery activities. We have an experienced management team, and we develop our products ourselves. But also to decrease the risk in the investment, we have ongoing partnerships. The company was founded in Canada in 1991 as AEterna Laboratories. At the end of 2002, AEterna Laboratories acquired German biotech Zentaris, thus becoming AEterna Zentaris. We have roughly 90 employees worldwide, with the majority in Frankfurt, Germany, our main scientific research location. Other employees are at our headquarters in Quebec City, Canada, and in Warren, N.J.
TWST: Tell us about your platform technology. Where did it come from and what is it focused on?
Dr. Engel: We are focused in oncology and endocrinology. In oncology we are developing perifosine, the first-in-class oral AKT inhibitor. A Phase III study, the last stage before commercialization, is currently being conducted in the United States with this compound in the indication of multiple myeloma, a form of bone marrow cancer, in combination therapy with Velcade(c). The study is being conducted by our licensee and partner for North America, Keryx Biopharmaceuticals, and is done under a special protocol assessment by the FDA. Perifosine has also been granted a fast-track designation and orphan-drug designation by the FDA. These designations should accelerate the FDA's review process once the study is completed and also provide perifosine with extra market exclusivity. We recently got an orphan-drug designation from the European Medicinal Agency for perifosine in multiple myeloma. Keryx is also about to start a Phase III study with this same compound in metastatic colon cancer in combination therapy with Xeloda(c) under a special protocol assessment. We currently are discussing the registration strategy with European agencies.
The second lead compound in oncology is AEZS-108, which is a unique targeting concept. It targets specific receptors called LHRH receptors, which are expressed in certain types of cancer, including endometrial cancer and ovarian cancer, two indications in which we are conducting a Phase II study in Europe. Last year we reported encouraging preliminary results. We expect to disclose the final results later this year. We also look to possibly conduct other clinical studies in bladder cancer, and pancreatic cancer and refractory prostate cancer. All these cancers have these LHRH receptors. In endocrinology we already have a marketed product for in vitro fertilization under the brand name Cetrotide(c). It is being marketed worldwide by Merck Serono, except in Japan, where it's marketed by Nippon Kayaku and Shionogi.
Our lead endocrinology compound in late-stage development is AEZS-130, which is in Phase III as a diagnostic test for growth hormone deficiency in adult patients. A former partner, Ardana, had initiated this Phase III program but had to abandon it after insolvency. So we reacquired all rights to this compound and are currently in discussions with the FDA in order to find the best way to finalize this study and file for an approval at the end of this year. We are also aiming for diagnostic use in children. And the unique selling point of this project is that this will be the first oral diagnostic test in this indication. So far, everything is in the form of either an intramuscular or an intravenous injection. The existing tests cause side effects that so far have not been seen with AEZS-130. We also have an orphan-drug designation for this drug in the United States. The interesting aspect is that this can also be used as a therapeutic agent. AEZS-130 has shown to stimulate appetite and therefore could be used to treat cachexia, a condition which results in a severe reduction of muscle mass and weight loss in patients suffering from conditions such as chronic obstructive pulmonary disease, AIDS and certain cancers. As you can see, we have very interesting late-stage projects. Our deep pipeline also encompasses earlier stage compounds in development.
At the pre-clinical development stage, we have some very unique molecules which are dual inhibitors of PI3K and Erk, two hot targets in oncology at present, and also a selective Erk inhibitor. Some of these early-stage projects as well as our more advanced ones will be the object of presentations at major conferences throughout 2010, such as the American Society of Clinical Oncology, ASCO, and American Association of Cancer Research meetings.
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