Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

Derek, a few points to consider.

I am more so worried about IPCI not getting the labels because of someone else's exclusivity, but I do believe Rexista meets the standards, it's just concerning not knowing what other exclusivity is out there.

Nobody knows what the FDA will do, especially under a new administration. But there are some important facts for you to consider and decide for yourself what you think it means:


1. Egalet's Arymo was given Approval with a "carved-out label," even though the Arymo AdComm voted 18-1 in favor of ADF label for IV, snorting, and oral abuse by chewing. They got ADF label only for IV abuse because the FDA rejected the chewing claim and because another product, Morphabond, which is not yet on pharmacy shelves, has marketing exclusivity for ER morphine with physical and chemical properties to prevent nasal abuse. I've never seen a company get approval for a drug and drop 40% like EGLT due to Arymo's carved-out label.


http://www.medpagetoday.com/neurology/generalneurology/62441

An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has "marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties."

2. OxyContin enjoys marketing exclusivity until August 2018. The ADF label for OxyContin includes IV and nasal abuse but it does not include oral abuse by chewing.

http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022272&Appl_type=N

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm



3. The only NDA or ANDA using OxyContin as RLD to receive approval thus far is Collegium Xtampza. This is only possible because Collegium has favorable court decision in their Paragraph IV patent challenge to Purdue. Per the Hatch-Waxman Act, a successful Paragraph IV challenge is an automatic bypass around Pediatric Exclusivity, which is the only way an OxyContin RLD drug can get Full Approval prior to August 2018. This is why IPCI wants Purdue to sue them. Now that the NDA is accepted, IPCI has 20 days to send their Paragraph IV notice to Purdue, and then Purdue has 45 days to file suit. Again, IPCI WANTS A LAWSUIT FROM PURDUE. Beating Purdue in court gives IPCI a bypass around OxyContin's Pediatric Exclusivity and a path to Full Approval, similar to Xtampza.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/07/pediatric-exclusivity-amazingly-powerful-essentially-ironclad-and-often-overlooked.html



4. There is a possibility for Rexista to get Approval with carved-out label. Similar to Arymo, they could get Approval to market but the ADF label would be restricted to oral abuse by chewing. They would not get IV or nasal label until OxyContin's market exclusivity expires. However, the window of opportunity may have closed on Friday when Collegium PR'ed topline data for their HAL study of oral abuse by chewing. If Xtampza gets the ADF label for oral abuse by chewing, then Rexista will not get that label until their marketing exclusivity expires.

http://ir.collegiumpharma.com/phoenix.zhtml?c=253995&p=irol-newsArticle&ID=2241241

Collegium Announces Positive Topline Results of Human Abuse Potential Clinical Trial Evaluating the Oral Abuse of Xtampza ER

CANTON, Mass., Feb. 01, 2017 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced positive topline results from an oral human abuse potential clinical trial, which was designed to evaluate the abuse potential and pharmacokinetics of oral administration of Xtampza® ER (oxycodone extended-release capsules) compared to chewed Xtampza ER, and crushed immediate-release oxycodone in solution in non-dependent, recreational drug abusers. The study met its primary and secondary endpoints of lower “Drug Liking” and “Take Drug Again”.

5. Just because a company says their drug is abuse deterrent does not mean that it is. An example is reformulated ADF Opana, which has been denied the ADF label. Opana is readily IV abused in a way which is known to cause endocarditis, clotting disorder, and HepC/HIV outbreaks. Most companies that are developing ADF drugs release the HAL studies in order to prove to investors that their product does what they say. IPCI has never released any HAL data for Rexista. When the FDA sets an AdComm for Rexista, then we should all get a look under the hood and see what the data actually shows. Until then, there is no reason to assume there are no problems, and there is good reason to wonder why this data has never been released to investors. Until the AdComm materials are published by FDA, we have only the word of the company that it cannot be crushed, chewed, snorted, or extracted.