Wednesday, May 7, 2014

TNI Biotech: Stealthy But Solid (TNIB)

You can add another market to the number where TNI Biotech Inc. (OTCMKTS:TNIB) has planted its flag. As of yesterday, the little biopharma company is now permitted to sell its low-dose naltrexone - better known ad Lodonal to doctors and patients - in Malawi, Africa, as a treatment for cancer. The drug has already received marketing approval in Nicaragua and Nigeria, with guaranteed revenue of $50 million stemming from the sales-partnership deal in Nigeria. With a third venue under its belt (never mind the many more yet to come), TNIB is very much validated as a viable biopharma investment.

Low-dose naltrexone, or LDN for short, is an immunology drug that induces a patient's own immune system to fight a better fight against a variety of diseases. The response to LDN is better suited for some diseases and ailments than others, however, and TNI Biotech has determined that LDN is a very effective option to treat certain cancers. The drug is not yet approved in the United States, but it is approved in three countries, and many more should be brought on board now that TNIB is the combination of two distinct organizations, one of which solely exists to market the drug and cultivate distribution partnerships and permissions.

It's an exciting early step for the young company to be sure, but it's only the beginning. The bulk and best part of the TNI Biotech Inc. is yet to come.

For starters, while low-dose naltrexone can fight cancer, it's also being evaluated in the United States as a treatment for Crohn's disease and multiple sclerosis. Final FDA approval for those two purposes could come as early as 2017 and 2018, respectively. Impossible to believe that one drug could do so many things? Not necessarily. In the same sense that an antibiotic or vaccine can stave off all sorts of germ-based and at least several viral-based illnesses, LDN can tweak an entire immune system to fight a variety of tough-to-beat diseases - it need not be a specific, targeted ailment for the drug to be effective.  

Oh, and LDN is only half of the company's pipeline. TNIB is also developed another immunology therapy called Met-enkephalin, or MENK, for short. It can be effective as a treatment for a variety of conditions, but it's shown particularly strong promise as a therapy for cancer as well, and pancreatic cancer in particular. TNI Biotech aims to begin phase 2 trials of MENK as an oncology treatment later this year, with approval of the drug for that purpose coming as early as 2019. Unlike many other biotechs of its size and ilk, however, TNI Biotech will be driving revenue via sales of approved products in a growing number of markets, largely funding its own trials rather than tapping public funding to foot the entire R&D bill.

Bottom line? TNIB may still not be a household name, but it's still a solid, budding speculation with a lot of potential.

You can visit its corporate website here. The timeline below tells the tale just as well though.

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