Israeli drug delivery developer Oramed Pharmaceuticals Inc. (TASE: ORMP; Nasdaq: ORMP) announced today that it has successfully concluded its meeting with the US Food and Drug Administration (FDA) regarding ORMD-0801, the Company’s novel oral insulin formulation.
At the meeting, the FDA gave clear guidance that the regulatory pathway for submission of ORMD-0801, would be a Biologics License Application (BLA). If approved, such a pathway would grant 12 years marketing exclusivity for ORMD-0801 and an additional six months exclusivity can be granted, if the product also receives approval for use in pediatric patients.
The 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. They also made specific recommendations for clinical trials designed to provide pivotal data prior to registration.
Since oral insulin may have a positive more physiologic first-pass effect on the liver with less systemic insulin exposure compared to traditional injectable insulin, at the suggestion of the FDA, Oramed also plans to initiate a three-month trial in patients with type II diabetes to evaluate the effect of ORMD-0801 on HbA1c, the main FDA registrational endpoint, later this year. In addition, the FDA confirmed the Company’s ability to use insulin from different suppliers like HTBT (Hefei Tianmai Biotechnology Development Co., Ltd., Hefei, China) in the Phase III study.
Oramed CEO Nadav Kidron said, “We are very pleased with the outcome and constructive advice received from the FDA during our meeting. We plan on implementing the FDA’s feedback in the coming months which should facilitate the confirmatory Phase 3 study and registration of ORMD-0801. Additionally, the FDA’s classification of ORMD-0801 as a BLA pathway and its significant commercial implications certainly is an additional exciting outcome for us.”
Oramed Pharmaceuticals is a pioneer in oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).
Despite the news, Oramed's share price fell 2.71% on the Tel Aviv Stock Exchange (TASE) today.
Published by Globes [online], Israel business news - www.globes-online.com - on September 5, 2017
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