Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

IntelliPharmaCeutics Intl Inc (USA) (IPCI) Needs A Partner

IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) just announced the submission of its New Drug Application (NDA) for Rexista, it’s bioequivalent OxyContin product. The application comes a little later than first expected, but it’s now in the bag, and the result could be a game changer for the company.

It’s targeting an abuse deterrent approval, and if the agency gives the asset a thumbs up for approval, and couples the approval with an abuse deterrent label, it could attract significant investor attention to IntelliPharmaCeutics. There’s also a strong potential catalyst on a commercialization partner announcement for the drug, meaning at its current valuation of $96 million (and taking into consideration a somewhat muted response to the latest NDA filing), there looks to be some degree of potential for a discount entry.

pharmacist, medical, retail, worker, team, young, staff, lab, chemistry, business, drug, chemist, adult, teamwork, drugstore, service,


Here’s what we know, and what we are looking for moving forward.

So, the drug is a bioequivalent version of OxyContin, as mentioned, the latter of which is currently marketed by the privately held Pardue Pharma. Estimates are just that, but analysts believe OxyContin generates somewhere in the region of $2.4 billion annually, and accounts for 99% of the $2.5 billion oxycodone sustained-release market. This is the market that IntelliPharmaCeutics is hoping to target, and that’s why this is such a big deal for the company.

What sets its candidate apart from the current option?

This is the billion-dollar question. IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) has been somewhat discrete about exactly how it expects to go about unseating the big name in the space, other than to say that Rexista is targeting a more all-encompassing spectrum of abuse deterrent properties. We know its proprietary production tech allows for the drug to be taken above-dose, without inducing overdose, or even an increased impact/euphoria, so that’s a major differentiator if the FDA agrees with the data that supports it. We also know that the drug’s designed to be resistant to abuse when combined with solvents and by nasal inhalation when crushed or powdered. It’s also a once daily product, which is a key differentiator.

All this aside, what are the chances of approval as an alternative to OxyContin?

Well, without factoring in any degree of differentiation on the abuse deterrence side of things, the drug almost looks a shoo-in for approval. The company conducted a host of early stage trials, having been notified by the FDA that if it demonstrated bioequivalence, as defined by FDA standards, it wouldn’t need to put the drug through phase III studies. It did, and it’s on this data that the application rests.

IntelliPharmaCeutics sat down with the agency to discuss trial design and definitions before everything kicked off, and then based on these definitions, compared the lowest and highest strengths of Rexista to the same strengths of OxyContin. The results showed that the ratios of the pharmacokinetic metrics, Cmax, AUC0-t and AUC0-f for the drug, when compared to the already approved blockbuster, are within the interval of 80% – 125% that is required by the FDA. Further, and just as importantly, this data came in with a confidence level exceeding 90%.

Basically, the drug works, as defined by having a similar pharmaceutical profile as that which it is trying to unseat.

So, what’s next?

Well, we’re looking for one of two things. The first is the acceptance of the submission by the FDA. It’s a NDA 505(b)(2) submission, which should speed things up a bit, but the agency has a habit of delaying these abuse deterrent bioequivalent submissions, so there’s no guarantee on that. We’re also looking for – and this is a big one – any announcement that the company has found a commercial partner on the drug. A cash injection is going to be needed if IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) wants to maximize this asset’s potential, and the company is actively seeking partners, meaning said injection is likely. The degree to which this injection will improve cash on hand remains to be seen, but at its current market cap, any number in the low double digit millions will serve up a considerable upside revaluation.

Bottom line here is that the company is not without its risks, and it’s product is far from guaranteed approval (and, perhaps more importantly, far from guaranteed abuse deterrent labeling) but at current price there’s plenty of potential rewards if things go to plan and it can pick up a commercial partner.

Follow Intellipharmaceutics Intl Inc (NASDAQ:IPCI)
Trade (NASDAQ:IPCI) Now!

Note: This article is written by Mark Collins and was originally published at Market Exclusive.

DOWNLOAD FREE REPORT: Warren Buffett's Best Stock Picks

Let Warren Buffett, George Soros, Steve Cohen, and Daniel Loeb WORK FOR YOU.

If you want to beat the low cost index funds by 19 percentage points per year, look no further than our monthly newsletter.In this free report you can find an in-depth analysis of the performance of Warren Buffett's entire historical stock picks. We uncovered Warren Buffett's Best Stock Picks and a way to for Buffett to improve his returns by more than 4 percentage points per year.

Bonus Biotech Stock Pick: You can also find a detailed bonus biotech stock pick that we expect to return more than 50% within 12 months.
Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.