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Bioenvision Readies Lead Product for Market; Reports Substantive Progress On Four Platform Technologies During Year Ended June 30, 2000

Business Wire, Nov 15, 2000

Business Editors/Health Writers

NEW YORK--(BUSINESS WIRE)--Nov. 15, 2000

Bioenvision Inc, (OTCBB: BIOV), a development stage anti-cancer biopharmaceutical company, today reported a net loss of $1,495,509 for the fiscal year ended June 30, 2000.

The Company also stated that it intends to market Modrefen, its lead product, in fiscal 2001.

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 four 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) 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) 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). 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."

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 received 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 twelve 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 of  Anticipated Time
Compound       to Be Treated       Development(1)     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/  Research &
                Diabetes/MS          development phase      5 years

(1) Development Stage refers to the current stage of development of the most advanced indication.

Bioenvision is a development-stage biopharmaceutical company primarily engaged in the development of products and technologies for the treatment of cancer. It has acquired development, manufacturing and marketing rights to four platform technologies from which a range of products have been derived and from which it anticipates developing additional products in the future. The Company intends to continue developing its existing platform technologies, acquire additional technologies and products with multiple uses when attractive opportunities arise from time to time, and commercialize products for the multi-billion dollar cancer treatment market. Although primarily focused on anti-cancer products, almost all of the products in its portfolio have a broader application. Bioenvision plans to develop non-cancer applications in partnership with major pharmaceutical companies rather than through independent development and marketing efforts.

 

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