For anyone interested, Alan Kohler done an interview with PR...

For anyone interested, Alan Kohler done an interview with PR three years ago, but which is still very relevant today. I can't include the link to the interview, but will include some excerpts. The agreement has since increased from 20-years to 25-years post marketing approval.

Some excerpts from the article/interview below:

You’ve mentioned Germany before, you’ve got a 20-year agreement with bene pharmaChem, is that right?

That’s it, yes, bene pharmaChem.

It’s their drug, right, PPS?

Yes, it’s their drug, they developed it back in the 1940s and they patented the drug back then and so the patent on the drug has since expired but the company continues to be the only FDA approved manufacturer of the drug. We thought it was very important for Paradigm to file our own patents, which we have, which are method of use patents – treating diseases with this drug, new uses that haven’t been thought of before. That’s what we’ve patented, the new use of the drug for treating these bone lesions and osteoarthritis, rheumatoid arthritis and so on. But we thought it was very important to protect the asset by securing an exclusive supply agreement with the German company.

We said to bene pharma, we will undertake to the clinical development and get the product through to registration and onto the market and that comes at Paradigm’s cost and Paradigm’s risk and in return we would like them to provide us with an exclusive supply agreement, which means any other pharmaceutical company that likes the idea of using this drug for treating these diseases can’t get access to the FDA approvement of the drug.

Will you be able to make it after the 20-year deal runs out?

Yes, we can certainly do that or we can extend the agreement. The agreement that is able to be extended to the expiry date of our last patent to expire. We’ve just filed new patents in 2019, so that agreement runs to 2039 and it can be extended for a further 10 years after that, or if we file new patents again in 2030, the agreement will run to 2050. It does provide us with a very important economic mote around the company, in that if people can’t get access to the drug, they themselves have to try and then go and discover how to make it and do the clinical development and they have to make sure it’s exactly the same as the bene material, otherwise it’s not considered to be a generic. Only exact copies can be classified as generic, so we think that we’ve got a very secure position with that exclusive agreement plus our patents to protect the use of the product in the marketplace.

It's made from beech trees, isn’t it?

Yes, so the actual compound is extracted from the bark of the European beech tree and that process of extraction is a very difficult one because there are many different molecules in the organic material. Extracting just the Pentosan, which is a five-sugar polymer, which is the backbone to the drug, is part of the art that the Germans have perfected. If you just take European beech tree and try and extract out Pentosan, you will get a whole range of other compounds and those compounds may or may not be beneficial for the patient. They may have deleterious effects. Making sure that you only get the Pentosan is very important and I think the Germans have definitely perfected that.

And then you add Polysulfate and sodium to it, is that right, or they do?

That’s exactly right, Alan. You get the Pentosan from the beech tree, it goes through a synthetic process of adding the Polysulfates and then extracting the sodium salt from that and then producing the very bottom of the process, Pentosan Polysulfate.

Very interesting. Great to talk to you, Paul, thanks a lot.

Thank you very much for your time, Alan.