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Sucanon Product Information

Summary
Sucanon™ is a very potent member of a new class of diabetic drug, with a very favorable toxicity profile. Sucanon™ is one of the most effective therapies for Type II Diabetes that is currently available. Sucanon™ is not plagued with the carcinogenicity, toxicity and other negative side-effects of some recently approved drugs or their analogues. It not only enhances the action of insulin, but also promotes muscle metabolism, corrects diabetes and reduces the level of certain circulating lipids. Clinically it improves both the metabolic and symptomatic aspects of Type II diabetes in a highly significant manner, whilst displaying a toxicity profile that is indistinguishable from placebo. The overall outcome is a very positive impact on the quality of life of these types of patients.

Background
The insulin regulating and metabolic effects of Sucanon™ were discovered in the laboratories of Biotech Holdings in Richmond, B.C., Canada. This led to the filing of broad patents which are pending. Preclinical and clinical testing was arranged in China at prestigious academic and clinical institutions. A complete NDA was filed with the Chinese Health Authorities and Sucanon™ has been approved without restriction as a prescription drug for the treatment of Type II diabetes, as well as being approved for treatment of Impaired Glucose Tolerance (IGT), a condition that frequently precedes Type II Diabetes. The drug was marketed in that-country for a period of three years but ceased to be marketed because of management difficulties in the Chinese subsidiary. Supplementary clinical trials were conducted in Brazil during 1999, showing Sucanon™ to be safe and effective for the treatment of Adult-Onset (Type II) Diabetes, with the critical glycosylated hemoglobin level (HbAlc) reduced to an average of 5.85% at the end of the trial.

Substance
Sucanon™ is a very potent member of a new class of anti-diabetic agents. It is a small molecular weight compound. Its final form is a small, coated tablet that is easily swallowed. Tablets are packaged in blister packs conveniently presented for patient use.

Toxicity and Carcinogenicity
Sucanon™ showed a therapeutic index in rodents in excess of 10,000, which is an unusually high margin of safety. An oral LDSO (Lethal Dose 50) was achieved as a result of mechanical obstruction rather than any organ specific toxicities. Six month oral toxicity studies in dogs and rodents revealed a distinctly unremarkable toxicity profile at doses of 500 and 2000 times the clinical dose.

  • Reproductive and fetal toxicity - were negative at all stages
  • Carcinogenicity and mutagenicity --- studies were negative
  • Safety pharmacology ---- did not reveal any action which could be problematic

Mechanism of Action
Preclinical and clinical data show that Sucanon™

  • Promotes action of insulin at many levels in the cell
  • Enhances metabolism of striated muscle
  • Corrects clinical and experimental diabetes mellitus
  • Lowers cholesterol and triglycerides in diabetics

Clinical Experience
Clinical studies have been carried out in both healthy adult volunteers and adult patients with diabetes mellitus of both sexes. Ethical review and informed consent were obtained in all human studies.

Generally it can be stated that Sucanon™ in the dose ranges studied did not reveal any pharmacological activity in healthy adults.

The pivotal study for submission was a randomized, double blind, triple parallel group active and placebo controlled, six month, multi-center comparative study of the objective and subjective efficacy and safety of oral Sucanon™ in patients with NIDDM (non-insulin dependent diabetes mellitus). Many of these patients were symptomatic. The results in patients showed that Sucanon™ administration was associated with:

  • significantly reduced symptomatology of disease
  • a toxicity pro file that was difficult to distinguish from placebo
  • significantly reduced hyperglycemia and glycosuria
  • significantly reduced hypercholesteroloemia & tryglyceridemia
  • a very high level of patient acceptability
  • significantly improved quality of life

Regulatory
An NDA (New Drug Application) was submitted and approved in China.

"...it is approved as an oral prescription drug for first line therapy of NIDDM (type 2 diabetes) in adults without restriction..."

A clinical study was completed in Brazil in 1999, further demonstrating the safety and efficacy of Diab IIT™. A regulatory submission was made in Mexico and regulatory approval was received in 2003.

Manufacturing
Active substance is manufactured at Biotech Holdings' facility in suburban Vancouver, B.C., Canada. Formulation and powder production is carried out at the plant. Currently,compression into tablets, coating and sealing in blister packs suitable for individual patient regimens is carried out under contract in Mexico.

Marketing
Biotech managed the manufacturing, commercialization and distribution of Sucanon™, also known as Diab II™ in China via a joint venture, Volque Pharmaceuticals, but discontinued this business in 2000. In Mexico, coordination of production and marketing is carried out through a wholly-owned subsidiary, PharmaRoth Pharmaceutical. Distribution agreements have been signed with partners in Peru, Argentina and Brazil.

Intellectual Property
The formulation of Sucanon is protected by industrial processing secrets. Two U.S. patents for combination use of Sucanon with non-insulin sensitizer diabetic medications have been assigned to Biotech Holdings.

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