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Biotech / Medical : Paracelsian Inc (PRLN) -- Ignore unavailable to you. Want to Upgrade?

To: Jonathan Schonsheck who wrote (4081)	1/15/1999 10:20:00 AM
From: Jonathan Schonsheck	Read Replies (2) \| Respond to of 4342

Threaders - Here's the BioFIT overview. At the end, I offer my own interpretation of a key passage. (1) Quality Assurance. The Company researches the scientific literature to determine the mechanisms of action for herbal or botanical products and develops assays to determine the range of activity for each of the biological functions the product could affect. The Company then uses its proprietary technology to evaluate these products based on how they perform in a scientifically selected battery of functional tests. If the product generates activity within the proper range for each of the activities being tested, the product is certified as BioFIT(TM), or "Bio Functional Integrity Tested," the Company's trademarked designation. BioFIT(TM) assays confirm consistent in vitro biological activities within a carefully defined range, closely associated with the benefit claims on the product's label. The Company intends to market the BioFIT(TM) designation to producers of herbal medicines and dietary supplements which the Company believes will enable these producers to (i) differentiate their products from similarly labeled products based on their products' consistent delivery of the benefits claimed by their producers; (ii) ensure "batch to batch" consistency in the production of their products; (iii) eliminate consumer confusion as to "which product to buy?"; and (iv) provide more "consistent" products and information in the herbal and dietary supplement market. The Company is completing initial BioFIT(TM) certifications for five herbal products. Assays to test these products are in the final stages of development. The Company is also working with the trade associations of the herbal and dietary supplement market to test product functionality. The Company entered into an agreement with R.P. Scherer North America in July 1998 that established R.P. Scherer as the exclusive marketing and distribution agent for the BioFIT(TM) Certification program in North America. In a related agreement, R.P. Scherer was also granted the worldwide rights to use the BioFIT(TM) program with its soft-gel products in the dietary supplement and OTC markets. The agreements allow R. P. Scherer exclusive use of the BioFIT(TM) Quality Assurance Certification program for a line of herbal supplements to be offered in a softgel capsule form. R. P. Scherer, acting as a contract manufacturer, will market the product line to wholesale customers worldwide. The initial roll out of five herbal products, along with the commencement of revenue to the Company is anticipated to begin in the first quarter of 1999. The Company anticipates that the agreement will result in the payment of significant development fees and licensing revenues to the Company in 1999. One of the herbal supplements being evaluated for the R. P. Scherer Agreement is Echinacea. In the dietary supplement industry, claims have been made that Echinacea acts as an immune system enhancer. R. P. Scherer provided 5 commercially available Echinacea products for the Company to evaluate using the BioFIT(TM) Certification program. The results of the evaluation are illustrative. 4<PAGE> After conducting a literature search and performing direct research, the Company scientists identified the TNF-alpha protein as the "mechanism of action" or biomarker for the stimulation induced in human immune cells. Company scientists then tested each supplement with the BioFIT(TM) Echinacea Assay to see which product was more effective in stimulating the TNF-alpha marker. The results of the test are summarized in Table 2. Table 2 clearly indicated that Brand C has the greater effect on the TNF-alpha marker. The evaluation also shows the wide range of bioactivity found in the different samples. Ordinarily, there would be no way to test the effect of a complex herbal compound on the TNF-alpha response. Researchers would have to identify the compound in the herb that they thought stimulated the immune response in humans. They would then test their product for the concentration of that compound and compare it to a benchmark concentration. In the case of Echinacea, some manufacturers standardize their product against a phenolic acid that is found only in Echinacea under the assumption that it is the active ingredient which results in the benefits claimed for the herbal supplement. Paracelsian scientists have found that it is possible to standardize the product for its concentration of the phenolic acid and have no bioactivity that would affect the human immune system. The BioFIT(TM) Assay allows R. P. Scherer to identify the herb samples which have an effect on human immune cells without having to conduct human or animal clinical trials and offers an inexpensive way of accurately identifying sources of raw material which have high levels of the relevant bioactivity. In addition, R.P. Scherer can evaluate, quickly and easily, its competitors herbal supplements. Echinacea - Preliminary Testing Immune Support Product-Induced Stimulation Macrophages to Produce TNF Product ---------------------------------------------- Brand Brand Brand Brand Brand A B C D E ----- ----- ----- ----- ----- TNF-alpha Response 0.249 0.145 1.054 0.057 0.717 This new BioFIT(TM) Certification Program which utilizes a unique "functional" approach to quality assurance will provide the natural products consumers more accurate information when purchasing herbs and other botanical products. BioFIT(TM) Certification is based on demonstrated biological activity in the product and goes beyond current analytical techniques that only measure the presence or absence of certain marker compounds. BioFIT(TM) Quality Assurance Certification bridges the gap between chemical assay methods of validation versus the use of animal and human clinical trials to validate the effectiveness of natural products relative to the structure and function claims being made. Read this part carefully: In the case of Echinacea, some manufacturers standardize their product against a phenolic acid that is found only in Echinacea under the assumption that it is the active ingredient which results in the benefits claimed for the herbal supplement. Paracelsian scientists have found that it is possible to standardize the product for its concentration of the phenolic acid and have no bioactivity that would affect the human immune system. My own interpretation: This is the QA method of PharmaPrint: checking for a particular compound. As I read it, this says that some stuff that passes the PharmaPrint test does not help the immune system. They are checking for the wrong stuff, and in the wrong place. (If the consumer can buy a product that's been PharmaPrinted, but may have no effect on one's immune system, or else a product that is BioFIT Certified, which does have an effect on one's immune system . . ..)