With possible pre-approval partnership in play, IGXT is one to watch Print E-mail
By Brian Wilson   
Wednesday, 26 October 2011 05:35

FDA CalendarShares of IntelGenX Corporation (OTCBB: IGXT) have risen just slightly from $0.47 pps since we told our premium subscribers the relatively under-followed story of the micro-cap biotech with an important pending FDA decision due in November. 

The drug delivery company which focuses on orally controlled release devices is based in Montreal and led by President and CEO Dr. Horst Zerbe. The firm has a pipeline of 14 products under development and the BioMedReports FDA Calendar and Worldwide Catalyst Tracker shows that the company has several upcoming catalysts including a possible FDA approvals of CPI-300 and INT0004 scheduled for a decision from regulators next month.

According to the company’s fact sheet, there are 47 million basic shares and 70 million diluted shares on the market. About 25% of the shares are held by insiders. As of this year, the shares peaked in July reaching a high of $1.06 per share before dropping down to the current price of $.50 a share for no obvious reason other than broader concerns over the economy and loss of interest in the company.

The main products that the company is developing in this field include the “VersaTab” Tri-layered tablet (an active core tablet sandwiched by erodible cover layers), the FDA-approved “VersaFilm”, which is a rapidly acting oral film which acts as a faster way to deliver medications to the bloodstream (it bypasses the gastrointestinal tract), and a unique “Mucoadhesive” tablet technology (a tablet that apparently sticks to the inside of your mouth for prolonged delivery of a drug).

On top of their drug delivery products, IntelGenX has numerous pharmaceutical products in development that incorporate the company’s improved delivery technology, and one that was already released in November of 2008 (a prenatal vitamin supplement). 

One of their biggest upcoming drug candidates is CPI-300. It has already received pre-approval inspection by the FDA and is due to have additional FDA approval by November 13th, 2011 under the PDUFA. CPI-300 is also known as INT0004, IntelGenX ‘s new strength antidepressant bupropion hydrochloride. Bupropion hydrochloride is an oral antidepressant drug of the aminoketone class. It selectively inhibits the neuronal reuptake of dopamine, norepinephrine, and serotonin. This new, higher strength of the antidepressant Bupropion HCl, the active ingredient in Wellbutrin XL, has been completed. A regulatory file for a 505(b)(2) New Drug Application submission was filed in April, 2009. In a complete response letter received on February 4, 2010, the FDA commented on the food effect, which was observed in the food effect study included in the NDA, and on the lack of a commercial manufacturer. Both issues have been resolved with new pivotal batches being manufactured by Pillar5 Pharma and, using product from these pivotal batches, a new clinical study that included a food effect arm, was completed. A response to the complete response letter was filed in the second quarter of 2011 and the FDA notified IntelGenX that it has accepted the resubmission of their NDA as a complete, Class 2 response, and has established November 13, 2011 as its target action date under the Prescription Drug User Fee Act.

The company is in the process of working out a licensing or partnership deal with other healthcare companies, while waiting for the FDA approval. In fact, at the recent Rodman&Renshaw Healthcare Conference management disclosed that there were advanced discussions for the drug in play with an anticipated deal structure that includes a 7-digit upfront payment and double-digit royalties plus sales milestones. The fact that a partnership agreement could be announced ahead of the regulatory decision and that makes this one a stock to watch and trade ahead of the PDUFA date.

Outside of CPI-300, the other drugs being integrated with IntelGenx’s improved methods of delivery are not expected to hit the market until 2014. Due to this, the performance of CPI-300 should have significant impact on the share price. Assuming FDA approval, the product is expected to be available in early 2012. The company could earn revenue through royalty payments before then however, which could get more investors interested.

M.E. Garza contributed research to this report.
Disclosure: None

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