Armed With FDA Orphan Drug Status in the U.S., PharmaCyte Biotech Now Securing Europe for Pancreatic Cancer Treatment

BONITA, CA--(Marketwired - October 09, 2015) - The combination of PharmaCyte Biotech’s (OTCQB: PMCB) signature live-cell encapsulation technology, Cell-in-a-Box^® with low doses of ifosfamide has already won the FDA's "Orphan Drug" status here in the U.S., and now it seems the company will also be awarded the “Orphan Designation” with the European Medicines Agency (EMA), which would guarantee 10 years of competition-free marketing when the pancreatic cancer treatment is approved.

In the world of biopharma, it doesn't take long for a company to copy or mimic a popular, successful drug. In fact, for some less-common diseases, the industry realizes that merely sharing the revenue generated by a small niche may not even be worth the effort, meaning those rare or difficult-to-treat diseases often go completely unaddressed. If all goes as planned for PharmaCyte and its novel pancreatic cancer treatment, not only does it stand to introduce a game-changing therapy to the market, it could be rewarded for its efforts with years of exclusive marketing rights in for its patented treatment.

In the U.S., the FDA has given PharmaCyte the Orphan Designation, which will give the company 7 years of marketing exclusivity when the company’s pancreatic cancer treatment is approved. Now, the company has hinted that it is close to securing the Orphan Designation with the EMA in Europe, which will offer PharmaCyte 10 years of marketing exclusivity when its treatment is approved.

PharmaCyte Biotech is the developer of a live-cell encapsulation platform biotechnology known as Cell-in-a-Box^®. In simplest terms, Cell-in-a-Box is a means of encapsulating and implanting living cells into a patient's body where they can drive a specific therapeutic effect. In the case of PharmaCyte's pancreatic cancer therapy, these encapsulations (about the size of the head of a pin) contain cells that produce an enzyme, which activates a cancer-killing drug called ifosfamide.

The advantage of this method of drug-activation is pinpoint placement within the body.

Ifosfamide is usually converted to its cancer-killing form in the liver. It works, but the bulk of the drug gets "lost" before reaching the pancreatic tumor given the pancreas is the last organ on the circulatory system. By moving the “activation site” from the liver to the site of the tumor -- by implanting about 300 of these pinhead-sized encapsulations at the site of the tumor -- ifosfamide isn't converted into its useful form until the last possible moment, insuring maximum impact of the drug at a minimal dosage.