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
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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
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Product 1 / Leukemia / Phase I, II / 3 years
Product 2 / Cancer support / Phase I, II / 3 years
Non-Cancer Applications
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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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