Elite Pharmaceuticals Inc (ELTP)

[NASDAQ2020]

Pfizer has saved Elite $30-$70 million dollars.

Quote:
So I will start by updating you on ELI-201 Oxycodone BID. Pfizer submitted an NDA in this category using the pharmacological approach, and we believe they will be getting an approval very soon. As I mentioned few minutes ago, Pfizer submitted for Oxy BID and the PDUFA date I believe was October and then the FDA requested three more months to evaluate their clinical trials and in January they were supposed to be receiving an approval and they announced that they haven’t yet and they are working with the agency. We await the FDA’s decision on Pfizer’s BID because it is very similar to our technology, it is a pharmacological approach and it is a capsule as well.
Elite plans to develop a generic of Pfizer’s product by building one of the – on the work that we have done already in this category, ABE2 Pfizers will be required but we intend to use these studies that we have already conducted, our previous fees and other support our submission. I think Pfizer is one of the best and largest pharmaceutical companies there is, Pfizer will lead the way and we believe that they can create a substantial market for this product. We will follow with a generic once this product is available in the market for us to compare ours then. There will be very few people who can do that. Because there isn’t anybody to the best of my knowledge that have this technology that Pfizer and Elite has. So this will be a very limited market for others to join in.
We expect the development program to be a lot less costly, of course, if we are making a generic versus making a NDA for the BID, it can run us about $30 million to $70 million. The generic will be a fraction of a fraction of that, and we will take the necessary steps once we hear what the FDA have to say and Pfizer gets their product to the market.