The last few weeks haven't been particularly encouraging for Crohn's disease sufferers. In August, GlaxoSmithKline (NYSE: GSK) and ChemoCentryx (NASDAQ:CCXI) reported that a jointly-developed Crohn's drug, vercirnon, had failed to meet its late-stage trial endpoints. Though the in-development drug isn't dead in the water (GSK and CCXI could rework the drug, the testing regimen, or use it for other indications), it doesn't look good. Then this month - just a few days ago - Coronado Biosciences Inc. (NASDAQ:CNDO) reported that its Phase 3 trials of Crohn's disease drug TSO had also failed to meet its primary endpoints as well. Like vercirnon, CNDO isn't completely out of luck here with the treatment, but forging ahead with further development of the treatment is grasping at straws. Crohn's sufferers don't need to give up home just yet, however - TNI Biotech Inc. (OTCMKTS:TNIB) appears to have a Crohn's treatment that works, and should be able to sidestep the problems that plagued ChemoCentryx, GlaxoSmithKline, and Coronado Biosciences.
Wait a minute. Isn't TNI Biotech the company working on cancer immunology drugs? How is it going to accomplish what CCXI, GSK, and CCXI couldn't? The answer is, yes, TNIB is probably best known for its cancer research, but the great part about immunology is that it's broad-based, and can be just as effective in the war against other conditions like Multiple Sclerosis and, you got it, Crohn's disease. In fact, the company's biotechnology appears to be highly-suited in the war against Crohn's.
The heart of the TNI Biotech opportunity to develop a treatment for Crohn's is rooted in a minor (at the time) study performed rather obscurely (also at the time) by the University of Pennsylvania's College of Medicine found that low-dose naltrexone, or LDN, was found to be an effective treatment for Crohn's conditions.
It's an important detail, pointing to the legitimacy of the idea; most drug discoveries that start in an academic setting tend to be the proverbial "real deal", as schools have little to no interest in creating highly-storied drugs.
If the term low-dose naltrexone, or LDN, rings a bell, it may be because that's what TNI Biotech drug Lodonal is... and it's already being sold, in some markets. A recent deals struck with AHAR Pharma in Nigeria guarantees TNIB $53 million worth of Lodonal sales in 2014 alone. Point being, though the drug is not yet approved in the United States for Crohn's, it is approved for similar indications in some overseas markets, and the potential has already been made clear.
That being said - and this is another detail the market may be overlooking - the introduction of LDN as a treatment for Crohn's may be closer than investors realize, and much closer to an approval than the company's other biotechnology, MENK, is to being approved as a cancer therapy.
How close? TNI Biotech is ready to begin Phase 3. It's just waiting to get the nod from the FDA. Assuming it starts those trials in 2014 (which is likely), Lodonal could be approved as a treatment for Crohn's in the United States as early as 2017 (mere minutes in biotech-time), doing what ChemoCentryx, GlaxoSmithKline, and Coronado Biosciences were unable to do. At that point, TNIB could be fiscally self-sufficient, funding the completion of its MENK trials against cancer ... the kind of thing biotech investors love to celebrate.
The bottom line is, not only is TNI Biotech not just a cancer play, it's a rather potent Crohn's disease play in an environment where other biopharma firms have struggled. It will still have to contend with category leader Humira, from Abbvie (NYSE:ABBV), and perhaps Stelara from Johnson & Johnson (JNJ) when the time comes; Stelara is currently in Phase 3 trials as a Crohn's treatment as well. Humira is only the leading drug on the Crohn's front because no real competitor has presented itself yet. It's not perfect. And as for J&J's Stelara, it's no slam dunk either. TNIB has as much potential - maybe more - in the $4 billion (annually) Crohn's market.
Sometimes the thing that makes a stock a hot commodity isn't the one you're expecting.
For more on TNI Biotech, visit the SCN research page here.
No comments:
Post a Comment