Toronto, Canada-based Intellipharmaceutics International, Inc. released news this morning to report that it has not received any notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by Wyeth Pharmaceuticals, the brand owner of Protonix® and wholly-owned subsidiary of Pfizer, Inc. (NYSE:PFE), for its application to bring to market a generic version of Protonix® (delayed-release pantoprazole sodium) tablets. Intellipharmaceutics announced in October 2010 that the FDA had accepted for filing its Abbreviated New Drug Application (ANDA) for its generic version of Protonix®. Per ANDA protocol, Intellipharmaceutics informed Wyeth that it had submitted paragraph IV certifications of invalidity and non-infringement for the patents that cover Protonix®.
According to the Hatch-Waxman Act, Wyeth had 45 days to file patent infringement documentation, which, to the best of Intellipharmaceutics’ knowledge, it did not. Because there was no documentation of patent infringement, Intellipharmaceutics will not be subject to the automatic 30-month stay of FDA approval when such contentions are brought forth; leaving the Company free to bring the generic version of Protonix® to market upon FDA approval.
As with any FDA decision, there can be no assurance of FDA approval, but this news puts Intellipharmaceutics in a prime position if the generic is granted approval as a therapy to limit gastric acid secretion. Protonix® is also prescribed 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, a rare disorder characterized by one or more tumors in the pancreas, duodenum, or both which cause the stomach to make too much acid. Protonix® generated $1.8 billion in sales for Wyeth in 2009 alone.
With several ANDA’s filed with the U.S. Food and Drug Administration, Intellipharmaceutics could be a play to keep an eye on in 2011. These ANDA’s are for generic versions of the extremely popular Focalin XR® (marketed by Novartis), Effexor XR® (marketed by Pfizer), and the aforementioned Protonix®. Additionally, Intellipharmaceutics possesses its patented Hypermatrix™ technology, which is a unique and validated multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. In its pipeline, the Company has several products in various stages based on the Hypermatrix™ technology that are being developed to address a variety of therapeutic areas including neurology, cardiovascular, GIT, pain and infection.
The Company has a miniscule share structure of less than 11 million shares issued and outstanding, less than five million shares in the float and a current market cap of under $30 million. When it comes to biotechnology stocks, there is always a degree of risk that is offset with large reward factor that sends biotech investors digging for companies with a large upside that are not in the mainstream of the general investment population. Intellipharmaceutics just may be one of those gems that captures significant attention in the upcoming year.
More information on Intellipharmaceutics International, its pipeline of products and the investment opportunity presented can be found on the Company’s website at www.intellipharmaceutics.com.