Here’s one to avoid – Oramed Pharmaceuticals Print E-mail
By Brian Wilson-Lead Contributor   
Tuesday, 11 February 2014 12:50
Oramed (ORMP) is another diabetes company that is looking to enter the insulin market. This time, the twist is that the insulin comes in an oral form (a capsule) with special proteins that allow for proper absorption. This is one of many (current) attempts to develop an oral formulation of insulin.

At this time, the main problem with Oramed’s product ORMD 0801 is that we know very little about the safety profile and the pharmacokinetics of this drug. The company presented data suggesting that no serious adverse events were seen in the completed Phase IIA, but we don’t have the full dataset and we cannot determine whether the FDA would take a 1-week trial seriously. I also question the size of the patient population (30), which is tiny for a Phase II trial for an indication as common as diabetes.

Interestingly enough, Oramed announced on February 10th that another Phase IIA protocol was submitted for another 1-week trial. Although the stock had a massively positive reaction, I see this as a red flag – not only for the existing Phase IIA dataset that is supposed to be “good” but the overall direction of ORMD 0801. The first Phase IIA trial was supposed to move the drug closer to a pivotal trial!

Oramed seems to attract the same people who are heavily vested in Mannkind (MNKD). It is also being heavily promoted by Aegis Capital (Ram Selvaraju still has a $30 price target) and others that have participated in this company’s deals.

I’m pretty sure there are no reputable funds buying this one out of genuine interest for the story or the pipeline. The supposed 8.7% institutional ownership is more likely made up of positions that were given to institutions as part of the financing deals made in 2013.

I could be wrong about my assumptions, but this one looks pretty shady. I’d steer clear of this one.

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