President and CEO of IntelGenX discusses the firm's pending FDA decision Print E-mail
By M.E.Garza   
Sunday, 06 November 2011 06:28
FDA DecisionShares of IntelGenX Corporation (OTCBB: IGXT) have been on a steady uptrend since we told our readers about the relatively under-followed story of the micro-cap biotech with an important pending FDA decision.

The firm's drug CPI-300 has been getting lots of attention after having already received pre-approval inspection by the FDA and is now due for the key FDA regulatory decision 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. Some observers believe that while a CPI-300 approval can become a financial win for the company it may also prove to be a key symbolic victory; one showing that IntelGenX can develop a product from the bench through approval.

It has not been an easy road thus far. In addition to fighting off Biovail in court, the Company had to respond to a complete response letter from the FDA which commented on the food effect (observed in the food effect study) and the lack of a commercial manufacturer. Both issues have been resolved and the target action date under the Prescription Drug User Fee Act has just been moved up.

At stake for the Company is also an important perception about the validity of their entire portfolio as a positive decision should allow investors to ascribe a higher probability of approval for the 10 other drugs within IntelGenX's pipeline. Speculators are hoping that this "halo effect" will give the stock a substantial lift which has little if anything to do with the financial value that the company will be able to realize from the commercialization of CPI-300 itself.

Horst G. Zerbe, Ph.D., is President and CEO of the Canadian company. prior to founding IntelGenx, Dr. Zerbe served as the president of Smartrix Technologies Inc. in Montreal, and as Vice President of R&D at LTS Lohmann Therapy Systems in West Caldwell, NJ. Dr. Zerbe holds over 40 patents in drug delivery related fields and has published numerous scientific papers in recognized journals.

BioMedReports: First, we wanted to reach out and ask you about the pending approval for CPI-300. We understand there has been a change to the original PDUFA date, is that correct?

Horst G. Zerbe, Ph.D.: That is correct. FDA moved up the PDUFA date by a few days. The new date is November 10.
BioMedReports: Can you talk about the importance of this pending approval development for your firm?

Horst G. Zerbe, Ph.D.: This is IntelGenx’ first NDA submission. The product, which involves a novel, patent protected formulation of bupropion hydrocloride – the active in Valeant’s Wellbutrin XL, was completely developed at IntelGenx. For the commercial manufacturing of the product, we secured a state-of-the-art, FDA approved manufacturer. The importance of this approval lies in the fact that the company would demonstrate that it is able to bring a product from inception to the market. This approval therefore constitutes a validation of the company and its oral drug delivery technology.
In the process, the company won a patent infringement suit brought forward by Biovail, thereby proving that it had developed novel, non-infringing, patentable IP. The product is protected by a patent which will be listed in the Orange Book.
BioMedReports: What can you tell us about this particular drug candidate's drug delivery platform and perhaps how it compares to some of the other drug candidates you've got in clinical trials?

Horst G. Zerbe, Ph.D.: IntelGenx has a total of three platform technologies that it uses to develop its products. CPI-300 uses our proprietary Versatab technology which involves layered tablet technology and uses hydroerodible polymers to control the release of the active from the tablet. We use this technology for all our controlled release products. The technology was initially developed as a cost efficient alternative to more expensive osmotic systems. It is characterized by its versatility. It is applicable to a large variety of drugs and can also be used for combination products.

Although it is our Versatab technology that will likely yield our first commercial product, the majority of our clinical work is actually with our oral, rapidly disintegrating film technology – Versafilm.  We believe there is an enormous opportunity for pharmaceutical films.  We have four film products in various stages of development and a pipeline of film candidates that are ready to go into the clinic.

We also have a third platform called Adversa.  Adversa is a mucoadhesive tablet technology which was designed specifically to achieve oral absorption of drugs undergoing first pass metabolization after gastrointestinal absorption.  We have one product in the clinic that utilizes Adversa.
BioMedReports: What are some of the important points you'd like investors to know about the pending approval candidate? (market potential, importance to patients, etc)

Horst G. Zerbe, Ph.D.: CPI-300 addresses a safety and compliance gap in the therapy of severe depressive disorders: Bupropion XL is only available in two strengths, 150 and 300 mg. Patients who are prescribed 450 mg of bupropion XL, typically have to take three 150mg tablets, or a combination of one 150 mg tablet and one 300 mg tablet. This bears a significant risk of patients misdosing themselves. For example, a patient could take two 300 mg tablets instead of one 150 and one 300 mg tablet. This would increase the risk of a seizure almost tenfold.

As to the market potential of CPI-300, 10% of all bupropion XL prescriptions are issued for the 450mg strength.  Bupropion is one of the top 5 prescribed anti-depressants in the United States.
BioMedReports: You have several drugs in the pipeline. What are some of the catalysts investors should be looking for in 2012 as far as IntelGenX is concerned?

Horst G. Zerbe, Ph.D.: Assuming a CPI-300 FDA approval, investors should look towards partnering and commercial launch news on the product in the first half of 2012.  That being said, I believe investors should be focused on our film pipeline in 2012, as it will be the source of the majority of our clinical, partnering, and regulatory news flow and milestones.  Following the successful launch of Suboxone, oral films have caught the interest of the pharmaceutical industry. IntelGenx currently has seven oral film projects in its pipeline and has been able to demonstrate bioequivalency in human studies with the reference product for four of those. The company plans to file 505(b)(2) NDA submissions for two of its film projects in 2012.



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