Intellipharmaceutics International Inc. recently announced it has achieved a significant advance in its program to develop and manufacture drugs incorporating abuse-deterrent characteristics. The company advises that it has taken delivery of and fully qualified its primary manufacturing equipment for the manufacture of an abuse-deterrent formulation of controlled-release oxycodone hydrochloride, and that the manufacture of clinical batches using that equipment has commenced. The successful manufacture of clinical batches is required to make the drug eligible for Phase I studies, and to establish a clinical program in cooperation with the FDA in order to facilitate advancement of the drug through the application process.

The drug delivery platform, branded Rexista, produces a unique dosage form designed to be deterrent to the well-documented abuses associated with currently marketed oxycodone products, such as the abuse of these drugs by nasal inhalation when crushed or powdered, and by injection when combined with solvents. Rexista products are also designed to deter release of the entire dose when consumed with alcohol, a significant problem with some opioid drugs. In 2008, controlled-release oxycodone drugs had US sales of approximately $2 billion.

“The qualification of this equipment is a significant step in our Rexista program,” said Dr. Isa Odidi, CEO of Intellipharmaceutics. “It involved the very difficult design and modification of certain aspects of the equipment to accommodate the novel and proprietary dosage form which we have developed for our Rexista drug program, namely a paste in a capsule. We have now commenced the manufacture of clinical batches of our oxycodone CR product using this novel delivery platform. The overall success we are having, including with Rexista and our two filed ANDAs for generics of Focalin XR and Effexor XR, is reflective of the capabilities and versatility of our proprietary technology platforms and our scientific and regulatory teams."

The company has announced that it and its licensee and development partner Par Pharmaceutical, Inc. received confirmation that the previously announced stays of the patent litigation concerning a generic version of Novartis' Attention Deficit Hyperactivity Disorder drug, Focalin XR (dexmethylphenidate hydrochloride), expired without regulatory intervention, and that the parties have stipulated to a dismissal of the litigation.

The parties, Intellipharmaceutics, Par, Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Celgene Corporation, Elan Corporation, PLC, and Elan Pharma International Ltd., have also entered into license agreements in conjunction with the settlements of the litigation concerning the company's generic drug application in the FDA for 5-, 10-, 15-, and 20-mg strengths of dexmethylphenidate hydrochloride. 

Intellipharmaceutics’ management presently expects that marketing of generic versions of the products will commence no sooner than the fourth quarter of 2012. The company has a 10-year profit-sharing agreement with Par for the sale of dexmethylphenidate hydrochloride XR capsules in the US, which commences with the commercial launch of the product by Par. Details of the license agreements remain confidential. In 2008, Focalin, including Focalin XR, had US sales of approximately $350 million. Intellipharmaceutics' application for approval of a generic version of Focalin XR remains subject to FDA approval. 

The FDA has accepted the filing of the company's ANDA for a generic version of the antidepressant Effexor XR (venlafaxine hydrochloride). The company's application will now proceed to full review by the FDA. No assurance can be given as to whether or when the FDA will approve the company's generic version of Effexor XR. Intellipharmaceutics is actively seeking a commercialization and distribution partner for this product in the US. Total combined sales in the US in 2009 for Effexor and Effexor XR branded products were approximately $3 billion.