Intellipharmaceutics and Par Pharma expand Focalin accord

Canada’s Intellipharmaceutics International (TSX:I) and US generic drugmaker Par Pharmaceuticals (NYSE: PRX) have added the development and commercialization of additional strengths of generic Focalin XR (dexmethylphenidate HCl) for the US market to their existing agreement, which applied to the development and commercialization of the 5, 10, 15 and 20mg strengths of generic Focalin XR, used in the treatment of attention-deficit hyperactivity disorder (ADHD).

Under the terms of the new deal, Intellipharmaceutics, specialist in novel and generic controlled-release and targeted-release oral solid dosage drugs, will receive an immediate cash payment from Par and will continue to receive a share of profits from future sales. According to Wolters Kluwer Health, US sales of Focalin XR were around $536 million for the 12 months ending June 2011.

The five original strengths of a generic version of Focalin XR are currently the subject of Intellipharmaceutics' pending Abbreviated New Drug Application with the Food and Drug Administration. Intellipharmaceutics and Par are parties to a settlement of their earlier US litigation against the patent holders of the drug, Novartis, and its partners Elan Pharma and Celgene, with respect to the 5, 10, 15, and 20mg formulations. The terms of that accord are confidential, other than granting rights to commercialize the copy version starting October 2012. Intellipharmaceutics and Par are currently defendants in on-going US litigation against the same plaintiffs with respect to the 30mg product.