BioLabs, Inc.

Overview

History

BioLabs, Inc., incorporated in NY, recently formed a 50% joint venture with Biotherapies, Inc. of Ann Arbor, MI to manufacture & distribute the MSA blood test which diagnoses & predicts breast cancer risk by measuring the mammastatin levels in women's blood.

Worldwide, mammastatin research is being conducted by only three entities, all working in cooperation together & located in Ann Arbor, MI: University of Michigan Cancer Center; Biotherapies, Inc.; & Mammast-atin Research Institute, a non-profit affiliate of Biotherapies, Inc. More than 10 years of research has consistently shown that the mammastatin protein is responsible for controlling abnormal cell growth in breast tissue. This protein has been found to be present in 83% of healthy women. All the women from high risk families lacked mammastatin, representing half of the 17% with no mammastatin. The protein was absent in the blood of approximately 90% of breast cancer patients, including those with a family history of breast cancer.

The mammastatin diagnosis has distinct advantages of current & emerging technologies such as mammograms, manual examinations, genetic screening, tumor markers, or sensor enhancements. Some of these tests cannot predict the risk of breast cancer, can detect only large tumors, or cannot determine malignancy. The absence or presence of mammastatin, on the other hand, has been shown to be an accurate predictor of the disease. Some of the new emerging technologies tend to be less accurate & do not take family history into account.

As a therapeutic, mammastatin is injected into the bloodstream of breast cancer patients on a regular basis -- similar to insulin injections for diabetics. This therapy proved highly successful in animal & human studies during 1996 & 1997. In pre-clinical tests on 29 women in the very late stages of breast cancer (less than 2-month life expectancy), the injection therapy was at least 70% effective in preventing the growth of breast cancer in all of the breast cancer cases tested.

Business/Products

Each test kit will come with an initial supply of reagent sufficient to analyze 100 blood samples. Subsequent reagent supplies are purchased as needed. The predicted cost of these kits is $3,500 and the reagent pack is $10 per individual test. Net operating profit per kit is about $600. Annual sales are expected by management to be $28 million by 2000.

The joint venture is seeking FDA "sanctions" for MSA in use to identify mammastatin levels, determine breast cancer risk, & monitor progress of mammastatin replacement therapy. FDA approval is not required, since the product is not a drug. Sanc-tions, however, lend credibility, so the joint venture intends to wait for that to occur before commencing sales.

Market

Breast cancer diagnostics & therapeutics represent a $10 billion industry worldwide. The market for the kit is comprised of two layers: 1) the actual purchasers -- the 2,000 labs in the U.S. which perform the assays; & 2) the drivers -- tens of thousands of doctors who draw the blood & send the samples to the labs for analysis. An estimated one in eight women are expected to contract breast cancer. The U.S. alone currently has 3 million breast cancer patients & survivors. The target consumer market consists of the following population segments:

Women over 30, as part of routine annual physical & gynecologi-cal examinations. Population: 50 million U.S., 420 million worldwide.

Breast cancer survivors, as part of routine, semi-annual mainte-nance check-ups. Population: 2.3 million U.S., 16 million worldwide.

Breast cancer patients, to monitor mammastatin levels monthly in conjunction with replacement therapy. Population: 700,000 U.S., 4 million worldwide.

Aggressive publicity will focus on the following: High level of MSA accuracy (approximately 90%); Ability to detect regardless of lump size; Quick & easy administration; It is further along than competitors for FDA approval; & It's value in conjunction with mammastatin therapy. Articles will be published in medical journals, presentations will be made within the medical communi-ty, & media interviews will be given.

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