Headquarters: Jerusalem, Israel
oramed.com
Founded: 2002
Oramed Pharmaceuticals reports of successful meeting with FDA regarding its oral insulin
- Co announced that it has successfully concluded its meeting with the 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.
- Such a pathway would grant a full 12 years of marketing exclusivity for ORMD-0801 if approved.
- On top of this, an additional six months of 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 2 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 in the Phase 3 study.
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Oramed Pharmaceuticals Inc. (Oramed) is engaged in the field of oral delivery solutions for drugs and vaccines presently delivered via injection. Oramed’s flagship product, an orally ingestible insulin capsule in phase II clinical trials, is focused on the treatment of diabetes. The Company is developing orally ingestible protein oral delivery (POD) technology for the delivery of drugs presently administered by way of injection. Oramed’s delivery platform protects protein sand enhances their absorption, allowing them to reach the blood stream through the portal vein. The Company’s products include ORMD-0801, Oral insulin capsule; ORMD 0901, Oral Exenatide capsule; and combination therapy of ORMD 0801 + ORMD 0901. ORMD-0801 is under phase II A clinical trials. ORMD-0901 is under preclinical/Investigational New Drug (IND) stage under phase I B.
Address
Hi-Tech Park 2 4 Givat Ram, PO Box 39098
JERUSALEM, 91390
Israel
JERUSALEM, 91390
Israel
Website
http://oramed.comKey stats and ratios
| Q2 (May '17) | 2016 | |
| Net profit margin | -318.48% | -1710.45% |
| Operating margin | -349.27% | -1561.62% |
| EBITD margin | - | -1561.00% |
| Return on average assets | -19.31% | -31.70% |
| Return on average equity | -38.32% | -42.98% |
| Employees | 12 |
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