The suit filed in the United States District Court for the Southern District of New York related to Intellipharmaceutics' generic version of Effexor XR (venlafaxine hydrochloride extended release) capsules.
Shares of the company have traded as high as $6.12 in recent months, but the lawsuit had cast a shadow of uncertainty that made speculators nervous. Volume and higher prices should return now that Intellipharmaceutics has been granted a non-exclusive license to the patents in a suit that will permit Intellipharmaceutics to launch a generic of Effexor XR(R) in the United States following U.S. Food and Drug Administration approval of this product.
According to Wolters Kluwer Health, sales of Effexor XR and generic versions of Effexor XR in the U.S. were approximately $2.8 billion for the 12 months ending May 2011.
"We are very pleased with the settlement of the litigation relating to our generic version of Effexor XR, as this removes a significant barrier to the commercial launch of our generic product upon FDA approval," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "With five products awaiting FDA approval, we continue to work aggressively to both advance and expand the number of products in our portfolio."
In addition, the news may set the table for the company to turn its full attention to some of the other pending news developments that were revealed as part of an exclusive interview with BioMedReports in April, when Odidi mentioned that several positive catalysts were on their way.
"We have 5 ANDA’s under review by the FDA at the moment. We continue to work very hard to try to meet our milestones. Part of the Seroquel filling is one attempt in that direction to meet our milestones for this year. We were looking to file two products this year, we just filled the one and the year is still early, so part of that point is that we are performing so far we hope that is the case. We continue to work on many generic products where a few we are first to file in the midst of this. We are hoping that the year is very good. Work is progressing in regards to the NDA front, we have the first NDA, which we made public, Oxydocone XR is our Rexista(tm) technology, which is progressing well. We are also looking at 2 other products in that same direction, but we have not named them yet.
We are also looking at a once a day solution for a drug that is currently taken multiple times a day. That has not been named publicly either."
In addition, Odidi indicated that IPCI is expecting some licensing deals to be announced.
"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."
IPCI and Odidi were recently featured on CNN. We continue to feel this is one of the most undervalued biotech stocks in the market, particularly when you consider that positive news about any of the company's pending FDA approvals could send shares much higher.
The reported sales for branded and generic versions of IPCI's pending approval products came in at approximately $8 billion in 2010. IPCI develops both ANDA (Abbreviated New Drug Application) product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway.
Disclosure: I am long IPCI.