$PMCB Europe Rolls Out the Red Carpet for PharmaCyte Biotech Cancer Treatment
PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has just been granted a key special status by Europe's medicine regulators.
As if PharmaCyte Biotech Inc. (OTCMKTS:PMCB) didn't have enough of a competitive edge already, it just garnered another one today. Europe rolled out the proverbial red carpet for its flagship pancreatic cancer treatment, just as the U.S. did last year. With years of guaranteed marketing exclusivity now in both key markets BEGINNING WHEN THE DRUG IS APPROVED (if it's approved), PMCB investors could be sitting on a proverbial gold mine.
In the unlikely event anyone reading this isn't familiar with PharmaCyte Biotech and its drug pipeline, it's really quite an amazing story. The biopharma outfit has devised a way to safely and effectively encapsulate living cells in a way that protects them from a patient's own immune system... the biggest hurdle to most live-cell implantations. The proprietary coating lets nutrients in and cell waste out , allowing those cells to function as they should within the human body. But, that same shell prevents white blood cells from attacking and killing what it sees as "foreign" to the body.
The biotechnology, called Cell-in-a-Box, has wide application, but first and foremost PharmaCyte Biotech is using it to wage war on pancreatic cancer by encapsulating living cells that catalyze a cancer drug called ifosfamide very near the spot of the tumor.
Most cancer drugs are catalyzed - turned into their cancer fighting form - in the liver. It works, but not as effectively as it could. By moving the point of catalyzation right to the tumor itself, a drug can achieve maximum efficacy with a minimal dosage. PharmaCyte can achieve this by depositing about 300 of the pinhead-sized encapsulations of engineered cells near the pancreas, confident that those living cells will survive safely in their "cocoons."
It's a novel idea, but hardly an outlandish one. Indeed, researchers have been trying for years to develop a successful encapsulation technique and formula, knowing its potential. PharmaCyte Biotech, however, is one of the very first to make it this far and put the technology to practical use.
As indirect evidence of the strength of the premise (as well as the dire need), the United States' Food and Drug Administration last year granted Cell-in-a-Box in conjunction with ifosfamide an orphan drug status. This simply means the FDA is so interested in getting a viable solution to a largely unmet need to the market that it will proverbially pave the way for a developer to complete the research and get that drug approved. Specifically, the orphan drug incentive in the U.S. is would give PMCB a total of seven years of marketing exclusivity if the company's pancreatic cancer treatment is approved, with the clock starting after any approval. The designation also secures generous long-term tax breaks, and in some cases it will even lead to developmental grants.
Fast forward to today. Per this morning's announcement, the European Medicines Agency (EMA) has also granted Cell-in-a-Box an orphan drug status for that market, which is even more generous than the U.S. equivalent. In Europe, orphan drugs have ten years of marketing exclusivity from the point of any approval. Europe also offers generous financial incentives to developers of orphan drugs.
While the tax breaks and grants are nice, the real value to PMCB owners is the fact that no other copycat company can poach the idea and compete with PharmaCyte. That's a huge deal, as it gives the company a wide, unfettered berth to tap into what could be a $2 billion global pancreatic cancer market in less than five years.
