Hi PZ,I was going through some of the older posts (ive missed...

Hi PZ,
I was going through some of the older posts (ive missed quite a few in the past (last year etc)..I saw this post from you and thought I should point out the research that 51Cap did a while ago, yes I know they certainly have a vested interest in PAR. But have a read, Oxxa kindly created a new thread if you want to read the article in full. I think it at least partly addresses the generics and how they shouldnt really be a threat. Anyway even if they manage to copy it and it has almost the same good effect as PPS it should hopefully be contained to countries where it is more difficult to pursue them for breach of patents.


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By way of example, one small alteration in any one of the steps, such as the quality of the charcoal, beechwood chips or temperatures can alter the final product and drug molecule. It's variations such as these that cause headaches for competitors who struggle to replicate PPS to a standard that is accepted by regulators (such as the FDA). If the end molecule doesn’t match the bene approved PPS on file with the FDA, it cannot be classed as PPS (not bio-equivalent). The manufacturing consistency and technical know-how developed over generations by Bene has allowed them to achieve batch consistency for their PPS and as a result, they remain the only FDA approved producer of PPS inside the US as well as other regions (i.e. no generic form of PPS is available for human consumption).
The below illustration from a structural study on PPS by Degenhardt M et.al, shows the differences between one competitors product & bene's PPS. The study showed the difficulties that other manufacturers have in replicating PPS, by confirming that the competitors' batches did not match the PPS monograph of benes’. Degenhardt also noted that “minor variations in the molecular shape and size of a drug can have profound effects on its pharmacological activities.” Therefore the FDA and other regulators have yet to approve other generic PPS manufactures.

Monograph of 2 different PPS manufactures (A,B,C bene) – competitor products have yet to achieve GMP & batch consistency to match molecule produced by bene.

After several days with the bene team discussing the complexities in the process of creating PPS, we left confident that the manufacturing facility and process would be extremely costly and difficult to replicate. Much of the equipment used in their facility has been specifically designed and custom-built using IP provided from bene (i.e. you can’t buy this equipment off the shelf).
One anecdotal story we were told during our trip, involved a major pharmaceutical company trying to undertake the manufacture of PPS during the 1970s. This company spent millions on developing the process for manufacturing PPS, but was unable to achieve batch consistency and ultimately abandoned the project. They returned to sourcing material from bene.