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


October 9, 2015 - Bonita, CA

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.

And, the company has already seen compelling results with this approach through the first part of its phase 1/2 trials.

In a test comparing the benefit of the Cell-in-a-Box delivery of ifosfamide versus historical results for the drug gemcitabine alone, the PharmaCyte approach improved the median survival time from 28 to 44 weeks. Equally impressive is the fact that the number of one-year survivors of the study's patients increased from 18% to 36%.

That was enough to get the FDA's attention, which has since granted the combination of Cell-in-a-Box and ifosfamide an "Orphan Drug" designation. Better yet, per Wednesday's news release, the company is in the process of securing the same Orphan Designation with the European Medicines Agency according to PharmaCyte CEO Kenneth L. Waggoner.

The FDA and other sovereign agencies created the Orphan Drug Designation as a means to encourage the development of treatments for rare diseases that may not otherwise be addressed by the industry. One of the more advantageous benefits of the Orphan Drug status is generous tax breaks, though the biggest upside may be multi-year marketing exclusivity. The FDA's marketing-exclusivity rights for its designated Orphan Drugs extend for 7 years after the drug is approved. The EMA's orphan drug program is similar, though it guarantees marketing exclusivity for a period of 10 years.

That's practically an eternity for a drug, during which time -- if ifosfamide and Cell-in-a-Box are approved -- PharmaCyte Biotech would continue to develop its biotechnology as a means of treating diabetes, and even brain cancer.

At stake is a piece of an underserved $2 billion pancreatic cancer market, a market that could prove very lucrative with the therapy's exclusive marketing rights being in place for several years after any approval.

The next step is the upcoming phase 2b clinical trial using Cell-in-a-Box® with low doses of the drug ifosfamide in hopes of providing patients with a treatment that meets a current unmet medical need in the treatment of advanced pancreatic cancer.

Read more articles and our research report on PharmaCyte Biotech at www.smallcapnetwork.com.

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