Intellipharmaceutics International (NASDAQ:IPCI,TSX:IPCI) wants to do more. The company recently announced new FDA approvals, new NDA filings, new partnerships and seems to be on the cusp of new developments for its products all throughout this year.
In a note issued on February 27, 2017, Mackie Research, which has a Buy recommendation on the company, noted that, “The Odidi’s continue to have a 100% approval success rate for products that are filed at the FDA.”
Aegis Capital Corp. also has a Buy recommendation on the stock, stating on their February 13, 2017, note that they expect Intellipharmaceutics to, “continue making progress in 2017,” citing that the company’s current cash will be able to support the operations through to June 2018.
Intellipharmaceutics has a wide product pipeline, seeking to help patients treat issues with neurology, cardiovascular, gastrointestinal tract, diabetes, and pain.
INN sat down with Intellipharmaceutics’ CEO Dr. Isa Odidi, to talk about challenges in the pharmaceutical industry, the company’s technology that combats drug abuse, as well as their competitors. Continue reading below for the full transcript of our conversation. It has been edited for clarity and brevity.
INN: In layman’s terms, how does your drug delivery technology work?
IO: In the past, a lot of researchers, at least not ourselves, have always heard that myth that you could make tablets that are hard to crush and therefore prevent abuse. The reality is that if you make a tablet so hard to crush that it is like steel, that tablet cannot release the drug content that it contains so you have to have a compromise. All the products that are out there in the market today claimed in the past, or continue to claim, that they are hard to crush, it is not necessarily true because the average users have access to simple equipment like coffee grinders that they can buy for $10. So there are certain devices that you can use to crush tablets. Our design does not emphasize the ability not to crush for two reasons: One, obviously you need to compromise the crushing strength versus release of the drug. Two, no matter how you make your tablet, the abusers can get something in the marketplace to crush the tablet and they do. What we have designed makes it so that, yes you can go ahead and crush the tablet, however if you crush the tablet, all the moisture content will suddenly gel… they form a very strong gel and become like bubblegum, therefore, you can’t snort them and you can’t dissolve them to inject them. That’s what we’ve done, that’s the area we’ve gone into.
INN: What are some of the challenges that you have faced in bringing your product to market?
IO: One of the challenges is getting through the FDA processes. It took a long time, especially for generics (to be reviewed and approved) but then the backlogs have been cleared and we’re pleased. As you can see in the last few months, we got two products approved and that’s good news for us. Because of the issues around approvals, we have now decided to focus on NDAs or new drug applications, because that area particularly in what is called the 505 b2 products. (The FDA approval process for) those areas seem to move very fast; you get a date given to you for approval right away, which is typically nine to 12 months from when you file your product, and that’s quite good.
Other difficulties you face is after approval you need to put this product on the market and we see in the US the dynamics for placement of generic products in the US market is changing with
the advent of new entrants from outside the United States. I don’t want to name countries, but the price structure seems to have changed and we’ve seen this impact some of the big companies even Teva or Endo and so those are the challenges we face. But nonetheless, I think we’ve tried our best, we have a partnership with Endo Pharmaceuticals to sell one of our products and recently we had an agreement with Mallinckrodt to sell three of our products. So, we are working very hard in that respect. The other thing we are trying to do is in the future consider registration of our products in our own label and trying to put products in the market, particularly the ANDAs (Abbreviated New Drug Application), the generic products, to sell them ourselves. Those are the challenges that we see from day to day when we’re trying to put products on the market.
INN: So are those challenges unique to Canada or the US or are does it happen on both sides?
IO: The challenges are basically unique to the United States, but Canada has not had the problem of being inundated with a lot of filings. I think to defer to the FDA sometimes, perhaps in 2008 they were suddenly inundated with so many requests for approval, a lot of foreign companies from India were trying to go into the U.S. market. The FDA just didn’t have resources to deal with that, but they are now doing something about it.
INN: Are Intellipharmaceutics products available in the US and Canada or just in Canada?
IO: In the United States, for now, that’s where (our products) are available. But we filed recently two products in Canada. Our (presence in the United States) started basically because of the market size. For example, our product Rexista, (will directly compete with a product that is selling) $2.5 to $3 billion dollar sales in the US if I am not mistaken. In Canada, this competitor is doing about $100 million, so we made a conscious decision to go after the US market first and then we look at Canada later. We have applied for two products to be approved in Canada. In the future, you will see more and more applications from us for Canada as well as the United States.
INN: The company has had good news, good analyst coverage and things seem to be going on the right track, but the stock has been down for over a year so what have you been telling investors?
IO: We’ve done very well in terms of ability to make this product we have, as I said earlier, 10 products filed with the FDA, we got three products approved and we expect to launch one of the three, one of them obviously is being sold right now, we expect to launch one in the next month, or two or three. What you would expect with all this good news and the filing of an NDA of Oxycodone is that the stock price should be very, very far north from where it is right now. It hasn’t been so, but what I have to say to the investors is that they should be patient. I think our company and our stock is for investors that are supposed to be into long-term investment, not just those that want to come and flip and make quick money. With a company with the kind of fundamentals that we have–10 products out with the FDA, potentially an NDA product, Rexista, which could generate huge sales if the –the NDA is approved. So far–we think it should be for people who want to be long on the project.
INN: Who are your closest competitors in the drug delivery market?
IO: Our company is a technology company and vertically integrated so we are doing drug delivery for all products in the world for any problem that’s out there. Unfortunately, these days you cannot find drug delivery companies. Companies like Biovail, where I was the head of research, those sort of companies don’t really exist today, like our company. What you have are companies in special niche areas, and in that respect, you can consider Purdue Pharma, for example, that is working on one of the products that we are also working on. You have other companies like Collegium [Pharmaceuticals] (NASDAQ:COLL) which is similar to us–they got approval for Xtampza, an Oxycodone capsule, then you have, obviously, traditional companies like Pfizer that’s doing everything all over the place, but they are competitors in the sense that they are also working on drug approval specifically for Oxycodone plus Naltrexone [Hydrochloride] product. Then you have Pain Therapeutics (NASDAQ:PTIE), again I think they are having some issues with the FDA with their product called Remoxy and they don’t have an approval yet. Then you have Egalet (NASDAQ:EGLT) that is working on abuse-resistant or abuse-deterrent technologies just like we’re doing and obviously, you have Teva (NYSE: TEVA), one of the behemoths, big, big player in the generics space and the new drug space. They are competitors from the point of view or the fact that they are working in the abuse deterrent area as well, and I think that’s what it is, but we are unique in the sense that we are a technology company. I mean we know how to design these products that are our bread and butter so to speak and we’re also vertically integrated as well. So, I think a lot of these companies have matured, we are just at an inflection point where we are trying to become big I hope, and that’s why we present a very good place for investors out there.
INN: What’s next for Intellipharmaceutics?
IO: On a specific level we’re looking at emphasizing a lot more on abuse deterrent technologies in the narcotics analgesic space, not just extended release, and we’re also looking at immediate release formulations. We are also moving into areas that are not just narcotic analgesics, they could be stimulants as well, any product that can be abused by users, those are the areas that we’re going to be emphasizing. We’re looking at prevention of overdose, which the FDA says is the biggest problem when it comes to abuse of drugs, not just the issue of crushing them, injecting them or snorting them but the fact that people tend to want to get a quick high by taking more than prescribed. So, I think that’s the future in this space and ideally the future of all drug delivery in the delivery of oral, or soluble forms. You notice that with people who may want to commit suicide, helpers or personnel mistakenly give them more drugs than they need to take or the elderly taking more drugs than prescribed because they forgot what they’re supposed to be taking. It’s a very big area more than just the narcotic analgesics. Then, of course, we’re working on Regabatin, which is the controlled-release pregabalin. Pregabalin is used for fibromyalgia and we think that area right now, the way it’s used is not adequate enough. We don’t think the patients are getting enough care from use of pregabalin, because you take it multiple times a day and besides that the coverage of the product is not extensive enough so we have come out with a better technology and with previous discussions with the FDA to get clinical trial protocol approved and get this product tested, and we’re very excited about this as well as several other ones that we have not made public yet.
INN: Sounds like a very exciting year for Intellipharmaceutics. Thank you so much for your time today.
Don’t forget to follow us @INN_Resource for real-time news updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in contributed article. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.