|FDA approval is a game changer for emerging biotech IntelGenx|
|By Staff and Wire Reports|
|Friday, 11 November 2011 07:05|
IntelGenx' lead product, CPI-300, for patients with Major Depressive Disorder has been given full approval by the FDA. The firm is engaged in the development of oral controlled release products. The company uses its unique multiple layer delivery system to provide zero order release of active drugs in the gastro-intestinal tract. The approval is a game changing milestone for the company, whose critics said the company might not be able to push their science from the lab bench to regulatory approval. Speculators had sold off some of their positions in anticipation of today's approval fearing that regulators might not give the affirmative go-ahead. Now shares appear undervalued given the impact this decision will have on the rest of the firm's pipeline.
CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.
"This is a defining moment for IntelGenx, as we have now clearly demonstrated our ability to independently take a product through development to regulatory approval," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We believe physicians will embrace CPI-300 as a more convenient and safe alternative for their patients requiring high-dose anti-depressant therapy. So we now turn our focus towards the commercialization of CPI-300, with the objective of a product launch with a partner by the second quarter of 2012."
Despite reports to the contrary, Dr. Horst explained in exclusive interview with BioMedReports that the drug has great potential: "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.
"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." explained Horst. "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."
IntelGenx has been in active licensing discussions with several leading generic and specialty pharmaceutical companies and anticipates finalizing a commercialization agreement soon. As previously announced, the company has entered into an agreement with Pillar5 Pharma Inc. for the commercial manufacturing of the product.
"For the commercial manufacturing of the product, we secured a state-of-the-art, FDA approved manufacturer," Horst said. "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."