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We are a pharmaceutical company currently engaged in the research and
development of innovative pharmaceutical solutions, including an oral insulin
capsule to be used for the treatment of individuals with diabetes, and the use
of orally ingestible capsules or pills for delivery of other polypeptides.
Oral insulin: We are seeking to revolutionize the treatment of diabetes through
our proprietary flagship product, an orally ingestible insulin capsule, or
ORMD-0801. In August 2017, we had a call with the U.S. Food and Drug
Administration, or FDA, regarding ORMD-0801. During the call, the FDA advised
that the regulatory pathway for the submission of ORMD-0801 would be a Biologics
License Application, or BLA. Such a pathway would grant us 12 years of marketing
exclusivity for ORMD-0801, if approved, and an additional six months of
exclusivity may be granted to us if the product also receives approval for use
in pediatric patients.
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