SemBioSys proceeds with plant-produced insulin

Canada's SemBioSys Genetics, a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, has provided an update on the expected regulatory strategy for its plant-produced insulin after a recent meeting with the US Food and Drug Administration.

The preparatory meeting for the company's Investigational New Drug Application for plant-produced insulin was scheduled as part of the normal development process. SemBioSys approached the FDA to confirm the viability of submitting plant-produced insulin under Section 505(b)(2) of the Food, Drug, and Cosmetic Act in order to achieve approval for a New Drug Application.

"Based on the discussions with the FDA and the agreed upon minutes from the meeting we will continue to pursue a 505(b)(2) regulatory path for our plant-produced insulin," said Andrew Baum, the firm's chief executive. "When we completed our initial public offering in 2004, the regulatory path for follow-on proteins remained relatively uncertain... Providing that our plant-produced insulin is sufficiently pure and clinically equivalent to commercially available insulin, the meeting confirmed the 505(b)(2) regulatory approach is an appropriate path for approval. During our discussion with the Agency we also established that there were no issues precluding the use of safflower as a production vehicle," he added.