Replies to post #25530 on Intellipharmaceutics International Inc. (IPCI)

[Tekterra]

I too believe Rexista will be of value and we will see deals signed prior to approval like management had planned for it. But, I don't know if we see it soon.

Ideally, we want to see a deal soon so that preparation for launch can be done upon approval like we discussed. Time frame could be end of year or early 2018.

April till end of September is still 5 months out, and I don't anticipate that tight of a schedule for FDA to approve exactly at 9/25 and a deal signed all ready to go. Minor delays will likely take place and we get an approval before year end.

So, likely scenarios is that we hear some sort of deal by Summer and potential launch early 2018 or as early as end of year 2017. But, I think early 2018 launch would be more likely. That's why I said we want to hold till summer and see what happens. Because if by June or July and we don't hear any deals, I'd be more concerned.

If we get a deal arround June, it could potentially launch early 2018 given it a 6 month preparation time as well as final FDA approval.

I think FDA panel review will be a catalyst too. Positive feed back will likely close a deal and ready to go. So, it is possible we won't hear a deal until then. That's one major event to look forward to. Because positive feed back pretty much signals an FDA approval.

[doogdilinger]

As always another well reasoned post Angelo! These next 6 months are the transformative era we've been patiently waiting for.

[numbersarefun]

AngeloFoca, Rexista bioequivalent but not true generic Oxycontin. I think bioequivalency is a selling point, since it is easier to switch between drugs. But that does not make Rexista a generic of Oxycontin. A true generic can be substituted by the Pharmacy.

It will be interesting to see what TE (Therapeutic Equivalent) Drug Rating, if any, the FDA gives to Rexista. AB-rating is what true generics are rated. FDA rarely gives TE ratings to NDAs. Since Rexista has different abuse-deterrent features than Oxycontin, I doubt FDA will give any TE rating.

In the unlikely event that Rexista gets an AB-rating to Oxycontin, I doubt Pharmacies would remember Rexista. A Pharmacist would dispense the Authorized Generic or true generic when available.

Egalet's ARYMO is bioequivalent to MS Contin. Drugs@FDA database does not have ARYMO listed as a Therapeutic Equivalent of MS Contin, and ARYMO listing does not have MS Contin as a Therapeutic Equivalent. Also, the FDA Orange Book does not have any TE (Therapeutic Equivalent) code listed.

I think the reason generics capture over 50% of the market so fast is because Pharmacies are allowed to substitute the generic when the brand-name is prescribed. So if a patient is prescribed Seroquel XR, the Pharmacist can dispense the generic since it is Therapeutical Equivalent and cheaper for the patient.

AngeloFoca wrote: "I propose that "possibly" it will not be at all the case... and that capturing 20% of the market can happen easily and within a year.

Unlike Pfizer's Troxyca, Collegium's Extampa, Egalet's Arymo... IPCI's Rexista is BIOEQUIVALENT to OxyContin... that's right... it can market itself as a OxyContin GENERIC...

I was looking for a post from last week that stated the stats on sales of Seroquel XR by the 180 day exclusivity holder - ???Accord, PAR, Handel??? - but I can't find it so I'm going by memory.

I believe it stated that it had captured over 50% of the market share from Astra Zeneca... and market size came down to perhaps 70% ?
"