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Tuesday, 03/14/2017 3:48:57 AM

Tuesday, March 14, 2017 3:48:57 AM

Post# of 38634
IntelliPharmaCeutics CEO Dr. Issa Odidi on preventing overdose death from Oxycodone, Fentanyl
February 23, 2017 Transcript:

James West: Dr. Odidi, thank you for joining us today.

Dr. Isa Odidi: Thank you very much for having me, and thanks to all the listeners out there, all those who are looking at this online or through whatever medium. Thanks.

James West: Let’s start with an overview of what is the value proposition for investors in Intellipharmaceutics?

Dr. Isa Odidi: Basically, the value proposition is that we are a company that is growing and we are at an inflection point at this current time; and (we)filed several ANDAs in the United States of which three have been approved, and we’re set to put one of them into the market soon, sometime around May. And I think the big thing happening now is the NDA that we filed for an abuse deterrent oxycodone medication for pain in the United States as a 505(b)(2) filing. I think we are currently awaiting FDA acceptance letter for that particular filing, and that is certainly a big milestone for this company. And of course, we have several other products in the pipeline.

James West: Are these products for pain management, are they opioid based?

Dr. Isa Odidi: Yes, they are opioid-based products and various combination products; particularly we’re looking at exploring the technology which are approved on the two new patents that we recently received. These are technologies to prevent overdose. I feel strongly that that will be a game-changer if we are able to prove that this technology actually works in real practice.

James West: I see. So this would have direct implications for the fentanyl overdose epidemic, I guess?

Dr. Isa Odidi: Most specifically for overdose from taking solid oral dosage opiates, for example, oxycodone, hydromorphone, hydrocodone, morphine, and the like, particularly in situations where you have a combination product of oxycodone and paracetamol, which is basically what’s in Tylenol. Typically, I don’t want to mention trade names, I don’t want to label other companies’ products, but typically there are products on the market that contain oxycodone, say, a low dose of 5 milligrams for example, and also contain paracetamol. People, in trying to get access to the oxycodone, only 5 milligrams, they tend to want to take many of those tablets at one time. The problem is that when they take multiple tablets of that product combination, they are basically taking too much of paracetamol, and this has very serious untoward effects on liver, and they really get hurt.

In such situations, if our technology, the PODRAS,what we call Paradoxical Overdose Resistance Activating System, it is incorporated in such a formulation or such a tablet combination, they won’t be able to feel that impact, because the large dose of paracetamol will not be released at all.

James West: Interesting. So what is the target market size, then, for this kind of a product?

Dr. Isa Odidi: I know people have looked at it including ourselves and with this sort of technology, basically, I wouldn’t even call it a product because it’s applicable to any solid oral dose form; it’s quite a huge market we’re looking at here, not just opiates, but in any situation where overdose becomes an issue, this technology could be used. We are talking in the billions, if the product works.

James West: Sure. Okay, and so for Intellipharmaceutics, how much money have you put into the company to get it to this point of evolution? How much has been invested in the company altogether?

Dr. Isa Odidi: That’s a very good question. I’ve not been doing any back-of-the-envelope math for this, but several millions have gone in. It could be close to $100 million gone into the company, but that is the way it is right now, and that’s little money compared to most other companies. And I think that’s one of the things we take pride in. We’re a very nimble operation, very effective with limited resources.

James West: Great. How did you start this company, and what’s your background?

Dr. Isa Odidi: My background is in pharmacy. I read pharmacy as a first degree, then I did a Masters in pharmaceutical technology at Kent College, University of London. And then I did a PhD in Pharmaceutics at School of Pharmacy, University of London. I have an MBA from Rotman School of Management, University of Toronto, and I’ve been to Harvard to do some other management programs as well.

I started this company after leaving Biovail together with my wife, Dr. Amina Odidi, who herself has similar qualifications. We came to Canada in 1995 to come and help Biovail, which was owned by Eugene Melnyk at the time, to help it become a very strong company. And we did a lot of products at Biovail, a lot of research was done. At the time, I was the Chief Scientific Officer and the Vice-President for Research and Development of New Technologies.

Around ’98, I left Biovail, and then my wife, who had earlier on set up Intellipharmaceutics in 1996 as a consulting company, and then we decided to vertically integrate the company, make it an R&D company and a manufacturing company. So it’s since 1998; it’s been a long time, but this is truly one of the true Canadian companies, it’s Canadian based, and although we are now public on NASDAQ and TSX, we can still lay claim to the fact that this is truly a Canadian company.

James West: Interesting, that’s a great story. Was Biovail the precursor to Valeant?

Dr. Isa Odidi: Yes, it is the precursor to Valeant. A successful company, Biovail. Very proud of the work we did there.

James West: Right. Okay, so what other products do you have in the pipeline at Intellipharmaceutics that might add to the future success?

Dr. Isa Odidi: Okay, we have several, and they have not been made public, so therefore I’m not going to speak about them. But the one that was made public is pregabalin. Pregabalin is used for fibromyalgia and neuropathy. Currently pregabalin is taken as a twice or three times a day product. We’ve come up with a technology platform that will allow you to take this product once a day. Not only that, it also gives better coverage with regards to the exposure of patients to the drug in the sense that, given the dosing regimen that we are applying for this product, if it becomes approved, that’s after doing our first clinical trials, is a product we are trying to dose just at night before going to bed. And we think this helps cover the problem that fibromyalgia patients are talking about, the drug they’re currently taking perhaps is not giving them enough coverage and exposure.

So I think that’s the next big thing, and here we’re targeting a market that is currently over $3 billion.

And then there are several combination products that are coming for opiates, these are based on our PODRAS technology, the abuse deterrent technology and the overdose technology. And then we are looking at several other once-a-day products with regards to hydromorphone,oxymorphone and hydrocodone. And like I said earlier, there are several more we haven’t made public, and therefore I won’t be able to talk about them.

James West: Lineup, I’m impressed. I’ve not heard of your company, but now that I have, we’re going to follow it with interest. I’d like to thank you for your time today.

Dr. Isa Odidi: Thank you very much for giving me the opportunity to speak to you, and your big audience.

James West: You bet. Thank you. Bye-bye.

Dr. Isa Odidi: Bye.

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