SemBioSys Follows Abbreviated Regulatory Path for Insulin Produced in Safflowers

The Canadian biotechnology company SemBioSys Genetics Inc. (Calgary, AB, www.sembiosys.com) will proceed with an abbreviated regulatory path for its proprietary plant-produced insulin, which has been demonstrated in animal models to be chemically, structurally, and functionally equivalent to US pharmaceutical-grade human insulin. The company decided on this regulatory strategy after a meeting with the US FDA.

The preparatory meeting for the company's investigational new drug application (IND) 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 for approval under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. Following the meeting, Andrew Baum, president and CEO of SemBioSys said the company would continue to pursue a 505(b)(2) regulatory path. By following this pathway, the company is submitting the product as a “follow-on” or generic protein product, and is not required to carry out the clinical trials required for new drugs and biologics.

“Insulin is a comparatively simple protein for which an extensive amount of clinical data on safety and efficacy already exists,” said Baum in a statement. “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.

Following the meeting, the company also received results from in vivo and in vitro biochemical and functional equivalence tests showing that its insulin produced from safflower, is indistinguishable from approved commercial human insulin analytically and physiologically.

The results from the equivalence testing are the most recent in a series of milestone events for the insulin program. In July 2006, SemBioSys exceeded its target level of insulin accumulation in safflower. In November 2006, SemBioSys signed an agreement with Cangene Corporation to purify safflower-produced insulin from SemBioSys’ seed lines under cGMPs for clinical trials. The company expects to be in a position to submit an IND to the FDA and intends to initiate a Phase 2 trial of safflower-produced insulin in late 2007 or early 2008.