PharmaCyte Biotech Inc (PMCB)

[pennyvestor]

FYI on PMCB's Facebook page posted a while ago this evening, refer below:

Pharmacyte Biotech Investors/Shareholders (PMCB)
41 mins ·

PharmaCyte therapy for pancreas cancer is already protected.

PharmaCyte’s pancreas cancer therapy was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the U.S. Food and Drug Administration (FDA) on December 17, 2014. This orphan drug status assures marketing exclusivity for PharmaCyte’s pancreas cancer therapy in the U.S. for 7 years after market approval by the FDA. Similarly, PharmaCyte has orphan drug status in the European Union (EU) for its pancreas cancer therapy. This designation provides 10 years of marketing exclusivity in all countries in the EU following approval by the European Medicines Agency (EMA).

In addition, the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010, establishes a period of 12 years of “data exclusivity” for reference products to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in a biosimilar application. PharmaCyte’s 12-year exclusivity will begin as soon as the FDA approves the company’s pancreas cancer therapy.

Mr. Waggoner concluded by stating, “While this patent application should make our investors feel assured about the protection of our pancreas cancer therapy, they should understand that if our pancreas cancer therapy receives FDA approval, the orphan drug designation in the U.S. and the EU, together with the BPCIA data exclusivity, will give us substantial marketing exclusivity for our pancreas cancer therapy. This new patent application, while it does include our pancreas cancer therapy, should really be viewed as an opportunity to dramatically broaden PharmaCyte’s ability to protect our therapy for all malignant tumors for the next 20 years.”

https://markets.businessinsider.com/news/stocks/pharmacyte-biotech-strengthens-protection-of-cancer-therapy-with-patent-filing-1002322186