Intellipharmaceutics International, Inc. reported this morning that it has not received any contention of patent infringement, as provided for under the Hatch-Waxman Act, from Wyeth Pharmaceuticals pertaining to Intellipharmaceutics’ Abbreviated New Drug Application (ANDA) for a generic version of Protonix? (delayed-release pantoprazole sodium) tablets. Per ANDA protocol, as the brand owner of Protonix?, Wyeth, a wholly-owned subsidiary of Pfizer, Inc. (NYSE
http://onlinetradersforum.com/styles...foro/clear.pngFE), was informed by Intellipharmaceutics that it had submitted paragraph IV certifications of invalidity and non-infringement for the patents that cover Protonix?.
The Hatch-Waxman Act allots 45 days for Wyeth to make a claim of patent infringement, which, to the best of Intellipharmaceutics’ knowledge, Wyeth did not. If a contention of patent infringement would have been filed, there is an automatic 30-month stay of FDA approval, which now will not be effected and opens the door for Intellipharmaceutics to move forward with marketing its generic drug pending FDA approval. The ANDA was accepted by the U.S. Food and Drug Administration in October of 2010.
This is a major step in the right direction for Intellipharmaceutics and its tiny market cap of under $30 million, as Protonix? sales approached $2 billion in 2009 for Wyeth. An FDA approval is never guaranteed, but this news puts Intellipharmaceutics in a prime position if the generic is granted in 2011. Presently, Protonix is prescribed as a therapy to limit gastric acid secretion as well as 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.
The Toronto, Canada-based biotech, which trades on both the U.S. Stock Exchange (NASDAQ:IPCI) and Toronto Stock Exchange (TSX:I), boasts a wealth of potential in its portfolio and has more than a handful of ANDA’s currently under review by the U.S.F.D.A. Along with the generic for Protonix?, Intellipharmaceutics has filed ANDA’s for generic versions of Focalin XR? (marketed by Novartis) and Effexor XR? (marketed by Pfizer) which, combined, total nearly $3 billion in sales for Novartis and Pfizer. Also, coming down the pipeline from Intellipharmaceutics are numerous drugs in various stages of development that are based on the Company’s 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. Intellipharmaceutics believes that this technology can improve therapies in many areas including neurology, cardiovascular, GIT, pain and infection.