Intellipharmaceutics International Inc. (IPCI)

[KantKill]

Intellipharmaceutics announces tentative FDA approval for generic Seroquel XR

Intellipharmaceutics (IPCI) announced that the Company received tentative approval from the U.S. FDA for the Company's abbreviated new drug application for quetiapine fumarate extended-release tablets in the 50, 150, 200, 300 and 400 mg strengths. The Company's tentatively-approved product is a generic equivalent for the corresponding strengths of the branded product Seroquel XR sold in the United States by Astra Zeneca (AZN). Pursuant to a settlement agreement between the Company and AstraZeneca dated July 30, 2012, the Company is permitted to launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of generic Seroquel XR, on November 1, 2016, subject to FDA final approval of the Company's ANDA for those strengths. Such FDA final approval is subject to a 180 day exclusivity period relating to a prior filer or filers of a generic equivalent of the branded product. To our knowledge, two companies have first-to-file status and may be in a position to launch on November 1, 2016, although we cannot be certain of that date. Our intent is to launch these strengths after FDA final approval following expiry of the other companies' exclusivity period(s). There are currently no generics of Seroquel XR available in the U.S. market as the product is still under Astra Zeneca's patent protection until November 1, 2017. There can be no assurance that the Company's quetiapine fumarate extended-release tablets in any of the 50, 150, 200, 300 and 400 mg strengths will receive final FDA approval, or if approved, that they will be successfully commercialized.

Woot! How great this news is to those who remained cautious. Now if I were expecting a partnership PR on a Friday at nearly 7pm EST, well, safe to say I would be much less satisfied, if not even slightly disappointed.

P.S IPCI, Thanks for scaring the vast majority of us.