Diabetes

Our Solution for Diabetes

The Problem

Aging populations and lifestyle choices are causing a rise in diabetes cases around the globe and developing countries are demanding greater access to insulin at an affordable price.

Our Solution

To answer this need, SemBioSys is producing human insulin from genetically engineered safflower. We believe our plant-made insulin will offer dramatic reductions in capital and operating costs and provide an accessible source of insulin to meet this exploding demand. In fact, SemBioSys could meet this increased demand with just three commercial farms.

What We Have Accomplished

We have achieved commercial levels of insulin production in safflower and demonstrated that our insulin is physically, structurally and functionally identical to pharmaceutical-grade human insulin. Discussions with the US Food and Drug Administration (FDA) have confirmed that safflower-produced insulin is eligible to follow a shortened drug approval process and we have filed an Investigational New Drug (IND) application to the FDA.

What We Are Working On

We have submitted a Clinical Trial Application (CTA) to the appropriate European authorities and, pending feedback, will initiate a Phase I/II clinical trial in the UK this year.

In addition to traditional insulin, we are working on insulin analogues that provide faster-acting or slow-release options for improved disease control.

We are seeking well-positioned manufacturing and commercialization partners to co-develop plant-derived insulin across the developed and developing world.

Diabetes & the Need for Insulin

  • Diabetes is growing at an alarming rate of one new diagnosis every five seconds
  • By 2025, the incidence of diabetes is expected to increase to over 380 million cases world-wide
  • According to the International Diabetes Federation, approximately 50% of diabetics requiring insulin therapy have limited or no access to treatment
  • From a global perspective, lack of access to insulin is the leading cause of death in children with diabetes