Stock Update (NASDAQ:IPCI): IntelliPharmaCeutics Intl Inc (USA) Announces FDA Approval for 500 mg and 750 mg Generic Keppra XR®


IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI), 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”) of the Company’s abbreviated new drug application (“ANDA”) for levetiracetam extended-release tablets for 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 Keppra XR® sold in the United States by UCB, Inc.

Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, “FDA approval of our application for a generic version of Keppra XR® is an important milestone for the Company. It is our first approved product developed in house at Intellipharmaceutics without the support or regulatory input of a development partner. We believe that this approval of our generic Keppra XR® product represents a strong validation of our core drug development and regulatory competence and our controlled-release delivery technologies. The approval, under the Generic Drug Fee User Amendments of 2012, or GDUFA, fee regime at the FDA, is perhaps also an indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review. We regard it as hopeful that some of the Company’s other 8 ANDA candidates will be accorded further attention soon. We are actively exploring the best approach to maximize our commercial returns from this new approval.”

Keppra XR®, and the drug active levetiracetam, are indicated for use in the treatment of partial onset seizures associated with epilepsy. According to Symphony Health Solutions, sales in the United States for the 12 months ended December 2015 of the 500 mg and 750 mg strengths of Keppra XR®and all generic equivalents, were approximately $168 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 levetiracetam extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialized. (Original Source)

Shares of IPCI closed yesterday at $2.63. IPCI has a 1-year high of $3.92 and a 1-year low of $1.73. The stock’s 50-day moving average is $2.26 and its 200-day moving average is $2.08.

On the ratings front, Maxim analyst Jason Kolbert reiterated a Buy rating on IPCI, with a price target of $6, in a report issued on January 19. The current price target implies an upside of 128% from current levels. According to TipRanks.com, Kolbert has a total average return of -20%, a 26% success rate, and is ranked #3662 out of 3666 analysts.

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.