Natural Pharmacy magazine, Vol.3, No.6, June 1999

Entering a Special Supplements Market

Howard Benedikt, D.C., M.S.

Aeterna Laboratories, Inc., was started in 1991 as the brainchild of an endocrinologist who wanted to create innovative products to improve quality of life. Now Aeterna is one of the larger biotechnology companies and went public on the Montreal and Toronto Stock Exchanges in 1995. Its mission statement proclaims that the companies goals are to develop, produce, and market innovative products contributing to the well-being of the world through alliances with strategic partners.

Natural Pharmacy recently spoke with Stephen Berh, Ph.D., Aeterna`s director of scientific affairs, about the company`s past, present and future.

Natural Pharmacy (NP): Aeterna is obviously not exclusively a pharmaceutical company.

Stephen Berh, Ph.D. (SB): No, in fact the company has three overall categories of products that are covered by two divisions of the company - the Biopharmaceutical Division and the Cosmetics and Nutrition Division. Our Biopharmaceutical Division concentrates its efforts on the research and development of antiangiogenic products for diseases such as cancer, arthritis and psoriasis, which are complicated by the formation of new blood vessels. Our Cosmetics and Nutrition Division produces active ingredients and finished products for companies in the nutritional and cosmetic industry, such as Estee Lauder Companies. In the everchanging competitive nutritional market, Aeterna has expanded to include proprietory manufacturing methods and advanced scientific research.

NP: What types of products does Aeterna market?

SB: We offer a liquid shark cartilage extract with proven antiangiogenic activity, which we sell under the brand name CarTCelI®. This dietary supplement has nothing to do with the other powder extracts of shark cartilage available. We also produce a line of grandular extracts from a specialized process to provide a specific set of proteins or active compounds. These extracts come from the thymus, liver, adrenals, mesenchyme and pancreas.

NP : How does CarTCelI® compare with other shark cartilage powder products ?

SB : Both are derived from the same biological material, which is shark cartilage, that is where similarities end. The differencies lie in the manufacturing process and what ends up in the finished product. Cartilage is a highly hydrated material, containing about 50-80% water depending on the source. In the manufacturing process of CarTCelI®, biologically active substancies always remain in their natural aqueous environment, which helps prevent the degradation of these bioactive molecules. In contrast, when cartilage is dried and powdered, some of these active ingredients are inactivated. Furthermore, when Aeterna extracts the product, we make it bioavailable by removing it from the cartilage matrix in which it is imbeded. The highly bioactive extract is kept in a low temperature during the manufacturing process so that its activity is kept constant. Finally, state-of the art ultrafiltration is used to concentrate these active fractions.

NP : What research has been done on this product?

SB: The research on CarTCelI® can be divided into research on the biological effects of the product and clinical research. A considerable amount of work has been done to demonstrate that CarTCelI® has antiangiogenic properties. An antiangiogenic product may prevent the development of problem-causing blood vessels as stated by Dr. Judah Folkman, who is a world expert on angiogenesis.

Recently we perfected an assay using human umbilical vein endothelial cells (HUVEC). The assay shows that our liquid cartilage extract inhibits the growth of these cells, wich are crucial to the phenomenon of angiogenesis. Furthermore, the product has shown no toxicity, so it is scientifically supported to be a completely safe antiangiogenic product.

NP : It is also an important effect on enzymes, correct?

SB: Yes, CarTCelI® helps to maintain the structure of the extracellular matrix found in cartilage, joints, and other connective tissues by inhibiting the matrix metalloproteinases (MMP), which are enzymes that break down collagen. By inhibiting these enzymes, the liquid cartilage extract helps to protect the extracellular matrix of the body.

NP : So, is this antiangiogenic and anti-MMP activity really bioavailable?

SB: Yes, a clinical study has shown that in subjects given this liquid cartilage extract orally, the migration of endothelial cells was significally inhibited compared to control subjects. We have submitted this study for publication in a well-known scientific journal, and it is a clear demonstration that the angiogenic activity of CarTCelI® is both absorbed and used in the body (....)

NP : There have been problems in the past regerding contamination of shark cartilage. What steps does Aeterna to prevent this?

SB : First, Aeterna`s extracts come from premium raw materials. In the case of CarTCelI®, for example, the cartilage is cleaned with water only, vacuum-packed in airtight bags, frozen, and then shipped while frozen to Aeterna. We also verify that this raw material is completely free of pesticides and heavy metals, and it undergoes extensive microbial testing to ensure that there is no contamination.

NP : What about Aeterna`s glandular products?

SB : Here, I should mention that he bovine extracts we use are all prepared from Canadian-certified animals that are bovine spongiform encelophalopathy (BSE)-free. Furthermore, all calves are examined by federal inspectors and veterinarians to make sure that the materials meet the strict requirements for human consumption products. Also, what truly destinguishes our products is that the cartilage and other tissues are extracted with water only. These extracts undergo molecular fractination and filtration at low temperature in a state of the art facility. this ensures a clear and sterile solution of small peptides with full bioactive potential.

NP : Some ñompanies selling glandular extracts as dietary supplements claim that their production contain specific growth factors. How do you respond to this?

SB : We think that it is preferable to replenish the body with a balanced cocktail of signaling molecules that help maintain or reestablish the body`s homeostasis, metabolism or balance - on which all health generally depends.

NP : Where are your products currently sold?

SB : They are distributed worldwide in response to requests from healthcare professionals, health food stores, and pharmacies in Canada, the United States, South America, Europe, and Asia.

NP : What is the connection between your products and pharmacy?

SB : Pharmacies are becoming increasingly involved in the dietary supplement and nutriceutical industries in order to meet the changing needs of their customers, but it is more important than ever that they preserve their image of providing scientifically supported products, such as those offered by Aeterna. Our products are not sold as pharmaceuticals, and they are available in the United States through healthcare professionals and retail markets looking for innovative natural products.

NP : What does the future hold for Aeterna?

SB : We are looking at new and exciting natural products supported by science and clinical studies. Some of these compliment our shark cartilage extract, while others are truly unique active ingredients from plant sources.

NP : A recent article in The Wall Sreet Journal discusses the establishment of a federal office to evaluate and regulate herbal medicines in Canada, with the goal of creating a separate category for nutritional supplements. Would be this a positive step?

SB : Yes, for both manufactures and consumers. Presently, in Canada, nutritional supplements are classified as food, so we are prevented from making structure function claims as U.S. companies do for their products. This places the burden of education on consumers. So, creating a category for supplements alone would give manufactures such as Aeterna freedom to provide customers with all the information they need to make informed choices about supplements.

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