On Monday, Intellipharmaceutics International Inc. (NASDAQ:IPCI) announced that yet another abbreviated new drug application (ANDA) has been accepted by FDA officials. Shares of the company rose as high as $3 before closing the day up 2.51% at $2.85 after we alerted our readers that the company may be on the verge of announcing another key development.
On schedule and as promised during several previous public presentations, the company has filed their second abbreviated new drug application of the year. This time for a generic version of Lamictal XR (lamotrigine extended-release tablets), an anticonvulsant drug used in the treatment of epilepsy. According to Wolters Kluwer Health (OTC:WOLTF), U.S. sales of Lamictal XR, which was approved by the FDA in June 2009, were approximately US$199 million for the 12 months ending September 2011 -- an 84% increase over the comparable period in 2010.
"We are very pleased with the filing of an ANDA for our generic version of Lamictal XR with the FDA as this not only represents the accomplishment of a key milestone for Intellipharmaceutics, it is also a very exciting addition to the five product candidates we currently have under review by the FDA," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "Our Hypermatrix technology platform continues to demonstrate its ability to replicate the release profiles of a cross section of drugs and we will continue to seek to exploit the capabilities of this platform to expand our pipeline of products in various stages of development. I believe Intellipharmaceutics is well positioned to generate future value for our shareholders."
Intellipharmaceutics now has six ANDAs being reviewed by the FDA for approval, with reported sales by others for branded and generic versions of these products being approximately $6.6 billion for the 12 months ended September 2011.
Loewen, Ondaatje, McCutcheon Limited's analyst Maria Luckevich, M.Sc., MBA followed today's news and immediately issued a price target of $4.75 for IPCI shares along with a "Speculative Buy" rating. Her report comes on the heels of another report in which the Company's “buy” rating was reaffirmed by equities research analysts at Ladenburg Thalmann in a research note issued to investors earlier in the month. Ladenburg analysts currently have a $7.00 price target on the stock.
Credible sources told BioMedReports on Monday that the company's first FDA approval may finally be set for announcement "very shortly."
The most likely approval candidate is a generic version of Focalin XR®. In fact, a February 2011 news release from the company pointed at that development as one of the milestones for 2011. Focalin XR® is an extended-release formulation of dexmethylphenidate and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 years and older. ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood and sales of Focalin XR® in the U.S. were approximately $553 million for the 12 months ending Aug 2011. In August, the Company and Par Pharmaceutical, Inc. (NYSE:PRX) added the development and commercialization of additional strengths of generic Focalin XR® for the U.S. market to their existing partnering agreement for the drug., which applied to the development and commercialization of the 5, 10, 15 and 20mg strengths of generic Focalin XR. Under the terms of the expanded agreement, Intellipharmaceutics was set to receive an immediate cash payment from Par and will continue to receive a share of profits from future sales.
Of course, another possible candidate for approval is the firm's generic version of the antidepressant Effexor XR (venlafaxine hydrochloride). In May of 2010, the Company announced that the FDA had accepted their filing the drug. Intellipharmaceutics' version of the venlafaxine hydrochloride extended release capsules utilize a proprietary controlled release drug delivery technology. It is one of at least 10 products that Intellipharmaceutics is actively developing for a dozen various indications. Sales of venlafaxine hydrochloride extended-release capsules in the U.S. were approximately US$2.6 billion for the 12 months ended August 2011.
As part of an exclusive interview with BioMedReports in April Dr. Odidi mentioned that the company was on its way to filing more products for approval. He stated that his team was working very hard to try to meet various milestones- including the filing of a second product (including the newly revealed Lamictal XR) this year. "We continue to work on many generic products where a few we are first to file in the midst of this," stated Odidi at the time. "We are hoping that the year is very good."
Shares of the company have traded as high as $6.12 in recent months, but a poorly received financing and a now-settled patent infringement litigation with Wyeth LLC, a wholly owned subsidiary of Pfizer (NYSE:PFE) had cast a shadow of uncertainty on the stock. Intellipharmaceutics settled the suit and was granted a non-exclusive license to the patents in suit that will permit them to launch a generic of Effexor XR in the United States following FDA approval of the product.
As we have mentioned before, we are very bullish on IPCI given that the firm develops both ANDA (Abbreviated New Drug Application) product candidates and new drugs through the New Drug Application 505(b)(2) regulatory pathway. Their CEO, Dr. Isa Odidi, is easily considered one of the sector's top drug delivery innovators. When Odidi was at Biovail- which merged with Valeant Pharmaceuticals International (NYSE:VRX) in 2010, he was performing drug alchemy with formulations that mimicked several hard-to-manufacture generic versions of expensive drugs- among them, Pfizer’s Procardia XL, Bayer’s OTC: (OTCPK:BAYRY) Adalat CC, and Novartis’ (NYSE:NVS) Voltaren XR.
While serving as Biovail’s Vice President of Research of Drug Development and New Technologies he helped grow Biovail into a multi-billion dollar company. Now he’s doing it all over again, this time with his own emerging biotech-- and many see it as extremely undervalued, given the events which are set to transpire there. That sentiment is underscored by the fact that the company is close to FDA approval and plans immediate commercialization of those drug candidates.
IntelliPharmaceutics' proprietary Hypermatrix(NYSE:TM) technology is at the core of its controlled-release drug delivery approach. Hypermatrix technologies are based upon the drug active being imbedded in, and an integral part of, a homogeneous (uniform) core and/or coatings consisting of one or more polymers that affect the release rates of drugs. Its technology allows for the intelligent and efficient design of drugs through the precise manipulation of a number of key variables. This allows it to respond to varying drug attributes and patient requirements, producing a desired controlled-release effect in a time and cost effective manner.
The company was founded in 1998 by Isa and Amina Odidi. You can watch a story profile about the company from CNN at this link.
Disclosure: I am long IPCI.