Pharmaceutical company Oramed Pharmaceuticals Inc. (NASDAQ:ORMP) (TASE:ORMP) said on Tuesday that it has successfully concluded its meeting with the US Food and Drug Administration (FDA) regarding its novel oral insulin formulation, ORMD-0801.

The company added the US FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801 would be a Biologics License Application (BLA). This would grant a full 12 years of marketing exclusivity if approved plus additional six months of exclusivity if the product receives approval for use in pediatric patients.

In conjunction, the US FDA confirmed that the approach to nonclinical toxicology, CMC and qualification of excipients would be driven by their published guidance documents, consistent with the company's expectations. The US FDA made specific recommendations for clinical trials designed to provide pivotal data prior to registration.

Following the successful meeting, the company plans to initiate a three-month trial in patients with type 2 diabetes to evaluate the effect of ORMD-0801 on HbA1c, the main US FDA registrational endpoint. In addition, the US FDA confirmed the company's ability to use insulin from a different supplier HTBT (Hefei Tianmai Biotechnology Development Co Ltd Hefei, China) in the Phase 3 study.

According to the company, it is seeking to revolutionize the treatment of diabetes through its proprietary flagship orally ingestible insulin capsule (ORMD-0801).