Profile: Intellipharmaceutics International Inc (I.TO)

Intellipharmaceutics International Inc. (IPC), incorporated on October 22, 2009, is a pharmaceutical company specializing in the research, development and manufacture of generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technologies are a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a range of existing and new pharmaceuticals. Based on its technologies, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including eight abbreviated new drug applications (ANDAs) filed with the Food and Drug Administration FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

The Company’s dexmethylphenidate hydrochloride extended-release capsules are a generic version of the marketed drug Focalin XR. Venlafaxine hydrochloride is indicated for the treatment of symptoms of depressive disorders. Dexmethylphenidate hydrochloride, a Schedule II restricted product in the United States, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). In February 2012, the Cmpany filed an amendment to the ANDA for a generic version of Focalin XR to include the 40 mg strength of dexmethylphenidate hydrochloride extended-release capsules. Pantoprazole sodium inhibits gastric acid secretion and is indicated for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease, as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Its metformin hydrochloride extended-release tablets are a version of the marketed drug Glucophage XR. Metformin hydrochloride is an oral antihyperglycemia drug indicated for the management of type-II diabetes.

The Company’s quetiapine fumarate extended-release tablets are a generic version of the marketed drug Seroquel XR. Quetiapine fumarate is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder. Its lamotrigine extended-release tablets are a generic version of the marketed drug Lamictal XR. Lamotrigine is an oral anticonvulsant drug used in the treatment of epilepsy. Its carvedilol phosphate controlled-release capsules, in development, are intended to be a generic version of the marketed drug Coreg CR. Carvedilol phosphate is indicated for the treatment of hypertension and heart failure. The Company’s non-generic product under development is Rexista oxycodone hydrochloride, intended as an abuse- and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. Rexista oxycodone is also designed to resist release of the entire dose when consumed with alcohol. In July 2012, the FDA approved a new Risk Evaluation and Mitigation Strategy (REMS) requirement for all extended-release and long-acting opioid medications.

The Company’s levetiracetam extended-release tablets are a generic version of the marketed drug Keppra XR. Levetiracetam is an oral antiepileptic drug used in the treatment of partial onset seizures in patients with epilepsy. Its desvenlafaxine extended-release tablets are a generic version of the marketed drug Pristiq. Desvenlafaxine is a selective serotonin and norepinephrine reuptake inhibitor indicated for the treatment of depressive disorder.