(Editors' Note: This article covers micro-cap stocks. Please be aware of the risks associated with these stocks.)
Expanding on its diabetes platform, Oramed (ORMP) just announced a key conference with the FDA that takes it closer to bringing its oral treatments to market. A pre-investigational New Drug (IND) meeting with the agency, scheduled to occur in the very near future, will allow Oramed to begin testing its oral diabetes drug, exenatide, one of the newest class of glucose-controlling compounds, the GLP-1 agonists. This is a landmark event for Oramed and a boon for diabetics who suffer with repeated injections and constant promises from pharmaceutical firms that have not delivered on attempts at better therapies. As I recently had written, worldwide giants like Sanofi (SNY) have had trouble with either the FDA or class action tort attorneys because of badly designed diabetes drugs.
The GLP-1 agonists are emerging as the best of pharmaceutical breed -- Victoza from Novo Nordisk (NVO) has vaulted the company's sales into the high double digits in the years since the drug's launch. Januvia, from Merck & Co. (MRK) is a $700 million-plus blockbuster. Last year, Bristol Myers Squibb (BMY) bought Amylin Pharmaceuticals for $5.3 billion in hopes that its GLP-1 agonist would be a contender. The GLP-1s not only lower blood sugar, but also reduce the risk of triggering hypoglycemia by balancing out the peaks and valleys all diabetics risk when administering insulin and, as a significant side benefit, prevent weight gain.
Upwards of 12% of the US population has diabetes, with at least two million new cases coming to light each year. Costs to our healthcare system including hospitalization, doctor visits, medication and lost work time are astronomical -- $245 million in 2012 and running over $13,000 per person annually. The International Diabetes Federation reports that 183 million people worldwide have diabetes but are not yet diagnosed -- most are Type 2 -- adding significantly to the 366 million already being treated.
What patients will potentially get from Oramed is the benefit of a GLP-1 agonist in oral form, something not available yet. Relief from injections has been a much sought after goal of diabetics all over the world, and Oramed has no viable competitors. Earlier this month the company enrolled its first patients in a Phase II trial of ORMD-0801, a tablet for Type 2 diabetics to control glucose. This latest news of an upcoming FDA meeting adds to the rapidity of Oramed's progress in a short amount of time.
Meanwhile, investors anxiously wait for approval of MannKind's (MNKD) faulted inhalable compound Afrezza, a technology that Novo Nordisk, the top maker of diabetes medications in the world, passed on some time ago. Even if the drug/device combination makes it through what has been an arduous process with the FDA's past misgivings, I believe selling the product will become a tough missionary sale to endocrinologists. This makes sense particularly when considering how many other, safer compounds are advancing in trials. One recent example is a new drug from Biodel, Inc. (BIOD) in mid-stage trials that acts like industry standard Humalog, a $3.5 billion offering from Eli Lilly (LLY), but with more rapid uptake, quicker therapeutic effects, a less injection site irritation.
Biodel has a market capitalization of $72 million; MannKind's is an astounding $2.2 billion, yet Oramed, with potentially the biggest breakthrough to happen in diabetes medicine, trades at only $56 million. A clear opportunity exists that should not be overlooked.
There are risks with this class of drugs, most notably pancreatic cancer. However, the European Medicines Agency just recently exonerated the GLP-1 agonists from their link to this disease. Not all data is in yet; several large studies are still underway and not expected to report results until next year. However, investors watching these developments should be mindful that Oramed's method of action in its GLP-1 agonist compound is different from competitors, so upcoming clinical data has a better chance of being favorable.
Keep an eye on Oramed. It appears to have an excellent relationship with the FDA and a superior oral technology that would be an easy sell to doctors after and assuming commercialization. What's best is that diabetics everywhere would seek it out and free themselves from a lifetime of inconvenient and sometimes embarrassing injections.