Post by icemandios on Oct 7, 2016 23:53:18 GMT
Intellipharmaceutics Announces FDA Tentative Approval for Generic Seroquel XR®
TORONTO, Oct. 07, 2016 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received tentative approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") 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 Pharmaceuticals LP (“AstraZeneca”).
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.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "We are thrilled the FDA has granted tentative approval of our generic version of Seroquel XR®, which should further demonstrate our core drug development competency in controlled-release delivery technologies. As Seroquel XR® has yet to come off patent protection, we believe the tentative approval represents a substantial commercial opportunity for the Company."
Seroquel XR®, and the drug active quetiapine fumarate, are indicated for use in the treatment of schizophrenia and bipolar disorder. According to Symphony Health Solutions, sales in the United States for the 12 months ended August 2016 of the 50, 150, 200, 300 and 400 mg strengths of Seroquel XR® were approximately U.S. $1.2 billion (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price).
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (which have received final United States Food and Drug Administration ("FDA") approval) and product candidates in various stages of development, including Abbreviated New Drug Applications ("ANDAs") filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application ("NDA") 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista® XR, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical OverDose Resistance Activating System, and Regabatin™ XR (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista® and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency's findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.
These poor bastards have had a string of ANDA's hanging out in the wasteland of FDA approval for several years. Abbreviated New Drug Application my ass.
Back when, foolishly believing an "abbreviated" application meant something...meant anything other than a multi-year hang out, I got in, and I got screwed, and I am flat, but I keep an eye on this one for what it represents. And what it represents is how the big pharma guys and the FDA conspire to keep prices for drugs up (Epipen ring a bell??? Anybody???).
Sooner or later, the chickens come home to roost. Sooner or later, somebody is going to fire a whole bunch of co-opted and paid off....hmmm ...family rated forum I guess.
Well. You know.
