CDR: Hope for Breast Cancer
Nov 17, 2000 * * * * * * * * * * * * * * Investors Spotlight by Looknofurther * * * * * * * * * * * * Bioenvision.co.uk (BIOV.OB) BIOENVISION READIES LEAD PRODUCT LAUNCH Reports Substantive Progress On Four Platform Technologies BIOENVISION INC. - OTCBB Symbol: BIOV.OB In a recent press release President & CEO Chris Wood commented, "The global anti-cancer therapy market, presently valued at approximately $16 billion, is poised for considerable further growth. We believe this market will double in the next 4 years. This expansion will be driven by innovative new therapies which should dramatically improve control over the disease. During the past fiscal year, we made substantive progress developing our four platform technologies. We intend marketing our breast cancer drug, Modrefen, in 2001. This product will compete in the market-place with drugs such as Genentech's (NYSE:DNA - news) Herceptin but it's novel mode of action puts it in a specific therapeutic niche. Extensive clinical trials showed that Modrefen is effective in up to 55% of patients with breast cancer who relapse after hormone therapy with drugs such as Astra Zeneca's (NYSE:AZN - news) Tamoxifen." Dr. Wood continued, "During the next 12 months we intend to find a co-development partner for our anti-leukemia agent, Clofarabine. This drug is in Phase II clinical trials and early results are encouraging. This product will compete with Fludarabine, which is marketed in the USA by Berlex, a subsidiary of Schering AG (717200D) and Pentotatin which is marketed by Supergen (NASDAQ:SUPG - news). We continue to make substantive progress on our Gene Therapy platform. In the past year the team added a second gene to the vector and conducted successful pre-clinical trials. The results have confirmed the ability of the vector to transfer DNA to skeletal muscle and for release of gene product into the blood stream. In an earlier clinical trial, with the albumin gene attached to the vector, patients with low serum albumin levels due to end-stage liver disease, had serum levels returned to the normal range after treatment. We believe that these agents have considerable commercial possibilities." Company Overview Bioenvision is a development-stage, biopharmaceutical company primarily engaged in the development of products and technologies for the treatment of cancer. Bioenvision has acquired development, manufacturing and marketing rights to four technologies from which a range of products have been derived and from which additional products may be developed in the future. Bioenvision aims to continue developing its existing platform technologies, acquire additional technologies and products with multiple uses, and commercialize products for the multi-billion dollar cancer treatment market. Bioenvision expects to begin marketing Trilostane for the treatment of post-menopausal breast cancer on a commercial scale in the United States and Europe in the second quarter of 2001. The product is already FDA-approved in the United States for another use. Bioenvision plans to apply to use the drug in the United States for treatment of hormone sensitive cancers, such as breast cancer and advanced prostrate cancer. In addition, three of the other products and technologies to which Bioenvision has acquired rights are presently being tested in clinical trials, and an additional eight are in the pre-clinical stage of development. Assuming the successful completion of clinical trials, Bioenvision anticipates that by the end of 2002, five of Bioenvision's products and technologies will have received regulatory approval for specific disease (primarily cancer) treatment indications in the United States or Europe and seven will be in the final stages of the clinical trial process. Bioenvision has had discussions with potential development partners over the past year and plan to continue to explore the possibilities for co-development and sub-licensing. Bioenvision expects to enter into a co-development agreement for at least one of our products within the next few months although there can be no assurances that any such agreement will be reached. Bioenvision is also working on a fourth group of compounds that act as cytostatic agents by stopping the growth of cancer cells. There are at least three potential products in this category, one of which is set for a Phase I clinical trial in the coming year. These compounds are at an early stage of development but the Company expects these agents to fill the product pipeline for the future. In March 2000, Bioenvision recieved an equity investment of $2 million from Bioaccelerate BVI, a Swiss-based investment company which enabled the Company to move ahead in its business plan during 2000. Bioaccelerate has an option to invest an additional $4 million in the Company and that investment relates to certain milestones in the coming 12 months. Product Portfolio The following is a description of Bioenvision's current portfolio of technologies, products and products in development. Product / Disease intended / Current stage /Anticipated Time to be treated of Development Until Marketed Cancer Treatment --------------------------------------------------------------------- Modrefen / Breast cancer / At market / - - - Abetafen / Prostate cancer / Phase II trials / 2 years Clofarabine / Leukemia, Lymphoma / Phase II trials / 18 months Clofarabine / Solid tumors / Phase I trials / 2 years Cytostatics / Bladder cancer / Phase I trials / 3 years RA inhibitor / Leukemia / Pre-clinical / 4 years Hormone blocker / Prostate cancer / Pre-clinical / 4 years Gene Therapy -------------------------------------------------------------------- Product 1 / Leukemia / Phase I, II / 3 years Product 2 / Cancer support / Phase I, II / 3 years Non-Cancer Applications -------------------------------------------------------------------- Trilostane / Cushing's disease / At market / - - - Trilostane / Alzheimer's disease / Pre-clinical / 2 years Clofarabine / Transplantation / Phase I trials / 3 years Gene Therapy / Vaccines, Cirrhosis, Diabetes, MS / R & D / 5 years HISTORY The Company was founded by Chris Wood and financed by Kevin Leech, who were responsible for the first two public biotech companies in Europe in 1987, being Medeva plc and ML Laboratories plc respectively. STRATEGIC RELATIONSHIPS London School of Pharmacy University of Cardiff National Institute of Cancer, Bari, Italy University College, London MD Anderson Cancer Center, Houston, Texas Southern Research Institute, Alabama Memorial Sloan Kettering Cancer Institute, New York Imperial College, London STRATEGY Bioenvision's strategy is to license and acquire products ready for clinical trials or at a late stage of development, and to use the expertise of Bioenvision's management to take the products through clinical trials and to commercially position the products for today's marketplace. Bioenvision will establish an oncology sales force for the North American market while establishing a joint venture sales force in Europe. This will give Bioenvision the ability to distribute products from Bioenvision's own pipeline as well as products from other biotech companies looking for a dedicated oncology distribution chain. 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