Intellipharmaceutics Intl. Inc. (IPCIF)

[WeeZuhl]

Thoughts on IPCI's oxy ER


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1. The poisonous blue dye in the first version of IPCI's oxyER was not a superfluous add-on. It had to be removed because it kills people in higher concentrations (You're welcome, America!). BUT, as poisonous as it is, the blue dye was a necessary component of the ADF because the drug can be chewed "like bubblegum," according to Dr. Odidi. Chewing is the most common route of abuse for ER opioids, and IPCI has never released the results of their chewing HAL studies. Without the blue dye, what is preventing anyone from chewing it, "like bubblegum"? If those HAL studies were successful, we would know about it by now, and we would be hearing about it over & over. No HAL results --> No confidence.

2. IPCI's Oxy ER is not Collegium's Xtampza. Collegium's drug is successfully challenging Purdue's OxyContin in the market because Xtampza is a totally unique formulation. It is superior to OxyContin in multiple ways but most especially in chewing resistance. Unlike Xtampza, IPCI's oxyER is an OxyContin clone. It has excellent syringeability data, which was revealed at the first AdCom, but we have never seen chewing or snorting HAL data. I highly doubt that IPCI's chewing data is even comparable to OxyContin, but even if it is, that will not get it approved. It has to be good enough to qualify for the same chewing ADF label that Xtampza has in order to be approved, and IMO, that is highly unlikely. And don't forget, IPCI's clone is still locked down in patent infringement litigation with Purdue.

3. The Odidi's recently expanded their loan to the company. If they had confidence in the drug's impending success, why wouldn't they buy shares instead giving another loan? Likewise, when the company was desperately trying to increase shareholder equity to maintain NASDAQ listing, the Odidi's never converted their loan to shares, which would have made the job much easier to accomplish. Dr. Odidi has also started a new venture in China. If the CEO shows no confidence in the future of the company, then why would I?

IMO, FDA will not look favorably on a chewable OxyContin clone. But if you have a strong stomach, be my guest. However, if you hold through the Adcom, I recommend wearing Pampers on January 15. Whatever happens to IPCI's drug on that day, it doesn't change the fact that the ADF opioid market has never developed as everyone hoped. With the exceptions of OxyContin and Xtampza, every other ADF drug is a miserable failure.