Just as the U.S. Food and Drug Administration (FDA) has accepted Intellipharmaceutics’s (NASDAQ:IPCI) Seroquel XR generic version’s abbreviated new drug application today, the company is also enjoying international attention from televised news coverage.
Intellipharmaceutics CEO Isa Odidi said his company was very pleased with today's FDA's acceptance of their filing for a generic version of Seroquel extended-release capsules, whose sales in the U.S. were approximately $823 million in 2010.
"We were very pleased with the FDA's acceptance of our filing for a generic of Seroquel extended-release capsules," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "I believe this speaks to the quality of our application and the work that is being performed at Intellipharmaceutics."
Seroquel XR is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder and major depressive disorder.
Intellipharmaceutics has five ANDAs awaiting FDA approval. The Company develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway.
In addition to the developments at the FDA, news network CNN is profiling Nigerian scientists Amina and Isa Odidi, founders of Intellipharmaceutics.
As we first reported to our readers in January, Dr. Isa Odidi of Intellipharmaceutics is easily one of the sector's genius drug delivery innovators. While he was at Biovail, Odidi was performing drug alchemy with formulations that mimicked several hard-to-manufacture generic versions of expensive drugs- among them, Pfizer’s (NYSE:PFE) Procardia XL, Bayer’s (OTCPK:BAYRY) Adalat CC, and Novartis’ (NYSE:NVS) Voltaren XR. While serving as the company’s Vice President of Research of Drug Development and New Technologies he helped grow Biovail through its adolescence into a 10+billion market cap company. Odidi also learned to navigate the FDA process and is now working on growing IPCI using the same basic formula.
We feel very bullish about IPCI and continue to believe that this will be a very profitable biotechnology play, particuarly given today's announceent and what we learned from Odidi himself during our exclusive interview two weeks ago.
"We are at the point where we are ready to expand manufacturing given that we have 5 products (filed) with the FDA and many more to come," Odidi told BioMedReports. "Also, we’re looking to expand the areas of Marketing and Commercialization.
"We expect some licensing deals to be announced as well. The licensing deals might be two pronged, 1st to license one or more of the products we have currently in front of the FDA to be marketing to the US and rest of the world and secondly to piggyback on that- a co- development program with one big pharmaceutical player. That is what is happening. Obviously we are also gearing up to manufacture these products cause we expect these products to get into to market after approval- at least the Focalin XR, so we’re gearing up and we are preparing space and equipment to make sure the products can be manufactured when the approvals come. Quite a lot is happening."
Find more coverage of the company from CNN here.
Disclosure: I am long IPCI.