Breaking News From Pharma & Bio Ingredients
Elite and IntelliPharmaCeutics To Develop Controlled Release Product
Posted on 2005-06-22 06:13:00
Elite Pharmaceuticals, Inc., Northvale, NJ and IntelliPharmaCeutics Corp., Toronto, a privately held, specialty pharmaceutical company, have entered into an agreement for the development of a generic, controlled release drug product with an addressable market in the U.S. of approximately $4 billion in 2004. A pilot bioequivalence study has already been completed and scale up will begin shortly. After scale up and completion of a successful pivotal bioequivalence study for the product, an ANDA will be filed with the FDA.
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics, stated, "The fit between the two companies and the timing provide excellent synergies. We have a significant product that is ready to be scaled-up for a pivotal bioequivalence study. Elite has a fully capable analytical laboratory and cGMP manufacturing facility, and our combined capabilities put all the pieces in place for a smooth and timely product development and commercialization.
Bernard Berk, Chairman and CEO of Elite, said, "We are pleased to join forces with Dr. Isa Odidi and Dr. Amina Odidi, IntelliPharmaCeutic's President and Co-Chief Scientific Officer, recognized leaders in the development of controlled release dosage forms. Elite will be combining its capabilities with IntelliPharmaCeutics for the development of an oral controlled release product with significant technological barriers, which may be awarded a period of market exclusivity. This development agreement supports Elite's business strategy of expanding its pipeline through in-licensing of controlled release products utilizing proprietary drug delivery platforms. This is the second product agreement completed this year."
Subscribe via RSS
