LinkBack URL
About LinkBacks
Reply
Reply With Quote
We are close to Partnership and FDA approval ..Market cap of 33 million is a big joke . Great buying Opportunity !! GLTA
Upcoming Milestones
Q3, 2011 Complete licensing agreement for CPI-300
Q3, 2011 Execute definitive agreement for new development and licensing VersaFilm project
Q3, 2011 Execute definitive agreement for bipolar disorder
Q4, 2011 Obtain FDA approval for CPI-300
Q4, 2011 Complete pivotal biostudy for anti-migraine VersaFilm
IntelGenx At A Glance...
(RTTNews) - Making approved drugs better by applying its drug delivery technologies is the business strategy of Montreal, Canada-based IntelGenx Technologies Corp., which trades over the counter under ticker (IGXT.OB) and on the Toronto Stock Exchange under ticker (IGX.V). With a pending FDA decision, it's time to take a look at this drug delivery company.
For readers who are new to IntelGenx, here's a brief overview of the company and its upcoming catalysts...
IntelGenx has three unique patented technologies to customize the release profile of orally administered drugs and maximize their therapeutic effect. The company has one commercialized product - a prenatal multivitamin supplement, and 10 products under development.
The prenatal multivitamin supplement, which is the first product fully-developed by IntelGenx and commercialized in November 2008, is marketed as Gesticare in the U.S. The prenatal vitamin product was developed in partnership with Azur Pharma, a privately held pharmaceutical company.
The most advanced drug candidate in IntelGenx's pipeline is CPI-300 for depression. IntelGenx partnered with privately-held Cary Pharmaceuticals in November 2007 to jointly develop and commercialize CPI-300. However, in May 2010, the company acquired full control and ownership of CPI-300 from Cary Pharma.
CPI-300 is a higher strength of bupropion HCl, the active ingredient in Biovail's well-known antidepressant Wellbutrin XL. CPI-300 was developed to broaden the dosing options for physicians while providing a more convenient dosing option to patients with major depressive disorder.
The New Drug Application for CPI-300 was initially submitted in April 2009 under the 505(b)(2) regulatory pathway. The 505(b)(2) regulatory pathway allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug").
After reviewing the CPI-300 NDA, the FDA issued a Complete Response Letter in February 2010, citing two main issues, namely, the qualification of a commercial manufacturing site and the food effect, which was observed both in CPI-300 and the reference product in the food effect study submitted as part of the NDA.
In May of 2011, the company refiled its NDA for CPI-300, addressing the concerns that were outlined by the FDA in its Complete Response Letter. Accordingly, the FDA decision date for CPI-300 is set for November 13, 2011.
CPI-300 is once daily 450 mg dose of Bupropion Hydrochloride Tablet. Wellbutrin XL is available as 150-mg and 300-mg doses of Bupropion Hydrochloride Tablet. The drug lost patent protection in 2006. Wellbutrin XL was one of the top-selling drugs, prior to losing patent protection, earning more than a billion dollars in sales. Biovail has been unable to successfully develop a single dose 450mg Wellbutrin XL and patients requiring higher dosage take multiples of lower strength.
With over 10% of patients on Wellbutrin XL taking high dose, IntelGenx sees a market opportunity in excess of $150 million for CPI-300.
Earlier this month, Pillar5 Pharma Inc, the contract manufacturing organization selected by IntelGenx for the manufacture of CPI-300 successfully passed a pre-approval inspection by the FDA. IntelGenx has an ownership stake in Pillar5, representing 10% of the issued and outstanding shares of Pillar5.
Now, about the other products in the pipeline...
In February of this year, the company successfully completed a pilot study of its novel oral film, INT0022 for bipolar disorder, demonstrating its bioequivalence to a branded anti-psychotic. This rapidly dissolving anti-psychotic oral film product candidate of IntelGenx is licensed to Israeli company RedHill Biopharma Ltd. under a binding term-sheet executed on June 14, 2011.
The company has also completed pilot biostudies of INT0020 - an oral film for insomnia, INT007 for erectile dysfunction and INT008 for migraine, thereby establishing their bioequivalency to branded products. The anti-migraine film product INT008 is also licensed to RedHill Biopharma Ltd under a binding term-sheet executed in April 2010.
Last November, IntelGenx acquired exclusive rights to, and ownership of, INT0010, an improved formulation of THC (dronabinol) for the symptomatic management of Multiple Sclerosis induced neuropathic pain and chemotherapy induced nausea. THC is a naturally occurring component of Cannabis sativa, also known as marijuana. Dronabinol is used to treat nausea and vomiting caused by cancer treatment.
INT0010 has already completed a successful phase I study of INT0010, demonstrating increased bioavailability of dronabinol and reduced levels of its psychotropic metabolite compared to the existing FDA approved THC product Marinol. According to IntelGenx, several companies have expressed an interest in commercializing INT0010, and discussions regarding a licensing deal have been ongoing.
A quick look at the balance sheet...
IntelGenx reported its second quarter results last week. For the three months ended June 30, 2011, the company's loss narrowed to $1.2 million or $0.03 per share from $1.7 million or $0.05 per share in the year-ago quarter. In the recent second quarter, revenues declined to $0.1 million from $0.3 million and expenses were down by 35% to $1.3 million.
As at June 30, 2011, IntelGenx had an accumulated deficit of $10.94 million and cash of $3.2 million. (All figures are in U.S. dollars).
Read more: IntelGenx At A Glance...
