In 2004, the World Health Organization predicted that by 2030, 4.4% of the world population will have diabetes, which equates to more than 366 million diabetics worldwide. Those figures indicate that diabetes is becoming an epidemic and supports the need for new and innovative products in the marketplace. There are three types of diabetes, Type 1 or Insulin Dependent Diabetes, Type 2 or Non-Insulin Dependent Diabetes and Gestational Diabetes.
In 2010 it is estimated the global market for insulin products (including administration devices) will be USD 16.4 billion. It has been forecast that by 2015 the global annual market revenue for insulin products will be in excess of USD 22 billion.
Type 1 diabetes is characterised by a pancreatic malfunction, which prevents the pancreas from producing insulin. It is considered to be a progressive auto-immune disease, as the beta cells of the pancreas are attacked and gradually destroyed by cytokine immune factors produced by the patient’s own body. Treatment of Type 1 diabetes requires insulin.
Type 2 diabetes is characterised by insulin resistance, in which the pancreas produces sufficient amounts of insulin, but insensitive insulin receptors fail to adequately respond. It is the most prevalent form of diabetes and accounts for 90-95% of all diabetic cases. The treatment goal for Type 2 diabetes is to ensure adequate insulin and to increase the insulin receptivity of the cell walls. Type 2 diabetes can be managed with oral anti-diabetics, sometimes in combination with insulin.
Gestational Diabetes is insulin-resistance in pregnant women during the period of pregnancy. It can cause various fetal complications and is an under-diagnosed condition worldwide. It is a version of Type 2 diabetes and usually corrects itself post-pregnancy. However, women who have had gestational diabetes, have a 20-50% likelihood of developing chronic Type 2 diabetes within 15 years of the gestational diabetes pregnancy.
The product aims to offer patients the world’s first transdermally delivered insulin, providing patients with long-acting, sustained release insulin over an 8-12 hour period. TPM/insulin will target Type 1 and Type 2 diabetic patients requiring regular glucose regulation by delivering a sustained insulin release to control and manage their diabetes.
Phosphagenics has established safety and pharmacodynamic activity in healthy subjects in two Phase I studies and in Type 1 diabetics with one small-scale phase II study. These studies, which were conducted in collaboration with the Joslin Diabetes Center of Harvard Medical School, demonstrated significant reductions in blood glucose, endogenous insulin and c-peptide levels from a single application of TPM/insulin, with no irritation observed.
In December 2009, Phosphagenics announced that its scientists have:
- completed dose optimisation of the insulin formulation, substantially reducing the amount of insulin required to achieve therapeutic dose
- completed and tested the matrix insulin patch on animals, demonstrating that blood glucose levels were lowered for the duration of the studies.
Phosphagenics is now reviewing commercial opportunities for this project.