Oramed touts PhIIa insulin pill study results; analysts say 'Prove it'

Israel's Oramed ($ORMP) boasted results this week from a successful Phase IIa trial of its insulin pill, saying the oral Type 2 diabetes treatment is safe and well-tolerated. But in the meantime, some analysts and media outlets have criticized the company for being less than forthcoming about the data.

Oramed's ORMD-0801 promises to be a winner in the diabetes community if it can navigate the regulatory process, offering for the first time an orally digestible treatment for diabetes. Companies like Novo Nordisk ($NVO), Bristol-Myers Squibb ($BMY) and India's Biocon are among others looking to cash in on oral insulin, but clinically speaking, Oramed has come the furthest.

In the Phase IIa study, Oramed says its pill met all primary and secondary endpoints in a 30-person Type 2 diabetes study, but the company didn't release data. They plan to present full results at a scientific conference, according to a release.

And this last part has eluded analysts who would normally get behind the prospect of an insulin pill, but who now are left asking Oramed to show investors what they've got.

Bloomberg quoted analyst Graig Suvannavejh of MLV & Co.: "The stock had made a very big move in a really short time with very little data being shared, so perhaps investors are now thinking that the stock is fully valued. This is an early-stage company with a very interesting technology. The data is intriguing, but now they need to demonstrate that it works in larger trials."

Adam Feuerstein of The Street came down a little more heavily, criticizing what he said was the study's relatively small size and a lack of information in the company's release.

"Oramed's handling of the ORMD-0801 data smacks more of stock promotion than credible drug development," Feuerstein reported.

After more than tripling in the past year, according to Bloomberg, Oramed's stock fell 4% to $24.94 on Jan. 30, the day of the release, and has declined steadily since then to $15.18 late Feb. 4.

- here's Oramed's release (PDF)
- see the Bloomberg report
- get Feuerstein's report from The Street

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