Healthcare Industry News: metformin
News Release - February 24, 2017
Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage(R) XRTORONTO, Feb. 24, 2017 -- (Healthcare Sales & Marketing Network) -- Intellipharmaceutics International Inc. (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 final approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths. The Company's newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage® XR sold in the United States by Bristol-Myers Squibb.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "FDA approval of our application for a generic version of Glucophage® XR provides further indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review, and further validation of our core drug development and regulatory capability. We are encouraged that some of the Company's other 8 ANDA candidates may be accorded further attention soon. We are actively evaluating options to realize commercial returns from this new approval."
Glucophage® XR, and the drug active metformin, are indicated for use in the management of type 2 diabetes treatment. According to Symphony Health Solutions, sales in the United States for the 12 months ended January 2017 of the 500 mg and 750 mg strengths of Glucophage® XR and all generic equivalents, were approximately $591 million (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). The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company's metformin extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialized.
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 (some of which have received FDA approval) and product candidates in various stages of development, including 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 RexistaTM (abuse deterrent oxycodone hydrochloride extended release tablets), based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), 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 RexistaTM 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.
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Additional risks and uncertainties relating to the Company and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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