SAINT LAURENT, QUEBEC, Aug 14, 2009 (MARKETWIRE via COMTEX) -- IntelGenx Technologies Corp. (IGX) (IGX)(US:IGXT) ("IntelGenx") today announced its results for the three and six months ended June 30, 2009.
Total Revenue increased 68% to $500.4 thousand in Q2 and increased 54% to $701.4 thousand year-to-date (2008: $298.0 thousand and $456.1 thousand respectively)
Total Expenses decreased 56% to $841.5 thousand in Q2 and 31% to $1,494.4 thousand year-to-date (2008: $1,502.9 thousand and $2,159.9 thousand respectively)
The Net Loss improved by 90% to $115.8 thousand in Q2 and improved by 56% to $708.8 thousand for the year-to-date (2008: loss of $1,151.5 thousand and $1,614.9 thousand respectively)
The Basic and Diluted Loss Per Common Share improved by 83% to $0.01 in Q2 and improved by 56% to $0.04 for the year-to-date (2008: Basic and Diluted Loss Per Common Share of $0.06 and $0.09 respectively)
Commenting on the results, Horst Zerbe, President and Chief Executive Officer of IntelGenx, said: "I am very excited to report that our revenue exceeded half a million dollars in the second quarter, and that revenue is up 54% year-to-date versus prior year. At the same time, all main areas of operational expense are significantly lower in the first six months of 2009 than in the same period last year, with R&D expenses down 22%, General and Administration costs down 15% and Professional Fees down 65%. Together with our recently completed financing and the filing of the 505(b)(2) NDA for our antidepressant CPI-300, we are well positioned for the future."
Raised CDN$4.2 million through a private placement - on July 13, 2009 the Company closed a private placement offering of approximately 10.5 million special warrants ("Special Warrants") at a price of CDN$0.40 per Special Warrant for gross proceeds of approximately CDN$4.2 million (the "Offering"). The Offering was made and the Special Warrants were issued to investors in the Provinces of Ontario, British Columbia, Alberta and Manitoba pursuant to exemptions from prospectus requirements under applicable securities laws in the Provinces where the offering was made, and from registration requirements in the United States Securities Act of 1933, as amended (the "U.S. Securities Act"). Each Special Warrant entitles its holder to receive, upon exercise or deemed exercise thereof, one common share of the Company (a "Unit Share") and one common share purchase warrant (a "Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share ("Warrant Share") at a price of US$0.80 until July 13, 2012. The proceeds of the private placement will be used to support the Company's strategic development projects and for working capital purposes.
Filed NDA with U.S. Food and Drug Administration (FDA) - on April 3, 2009 the Company and Cary Pharmaceuticals filed a New Drug Application (NDA) under CFR 21 paragraph 505(b)(2) for the CPI-300 antidepressant. CPI-300 is a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder ("MDD").
The NDA has been formally accepted by the FDA for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
IntelGenx and Cary Pharmaceuticals entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral delivery technology. Under the terms of the Collaborative Agreement, IntelGenx raised $2 million in March 2008 to fund completion of the product development and Cary Pharmaceuticals acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharmaceuticals would share profits.
Announced Positive Phase 1(b) Clinical Study Results for Relivar - on April 14, 2009 the Company and Cannasat Therapeutics Inc., announced positive results for the Phase 1(b) clinical trial of Relivar, the first buccal dronabinol drug delivery product, which was developed using IntelGenx' proprietary AdVersa™ buccal delivery technology. Buccal delivery allows for drug absorption from the mouth directly into the bloodstream as opposed to the intestinal tract absorption seen with oral tablet technologies.
In this clinical trial, Relivar delivered twice the amount of dronabinol into the bloodstream versus the reference drug Marinol (as measured by AUC) with no increase in adverse events. The randomized, single dose, double crossover study compared Relivar to the reference oral dosage form of dronabinol (Marinol) at 2.5 mg in healthy volunteers. Relivar was well-tolerated with no adverse events noted in this study. Relivar met its primary goal of delivering a greater dose of the drug through the buccal mucosa versus the reference compound, Marinol, which is swallowed and has an intestinal absorption mechanism. Relivar also showed nearly a 50% reduction in the ratio of 11-OH-THC to the parent drug versus oral dronabinol in the same subjects. Literature suggests that the 11-OH-THC metabolite, which is also a marker of absorption in the gut, is responsible for the pronounced CNS adverse events of oral Marinol (or dronabinol). Relivar also showed an extended absorption profile which may be advantageous for more convenient dosing.
Signed New Partnership Agreement with European Pharmaceutical Company - On January 15, 2009 the Company announced a new partnership with Circ Pharma Limited, a specialty pharmaceutical company based in Ireland, to develop and commercialize a novel drug for the treatment of hyperlipidemia. This is the first product in a series of Circ Pharma's controlled release lipid lowering agents specifically designed to target the absorption of drug in order to reduce the effective dose and potentially lower the side effects.
In May 2009 IntelGenx and Circ Pharma announced that they have completed the formulation development of CRES Pravastatin (Controlled Release Enhanced Statin), and that they will enter the clinical development phase to initiate the proof-of-concept programme.
In accordance with the Agreement, IntelGenx will be responsible for the formulation, manufacture and supply to Circ Pharma of the drug product. Circ Pharma will be responsible for commercialization of the product. Under the terms of the agreement, Circ Pharma will fund the development of the product and IntelGenx will receive royalties from the product's sales. IntelGenx will use its proprietary VersaTab™ technology to formulate the product.
Hyperlipidemia is an elevation of lipids (fats) in the bloodstream. These lipids include cholesterol, cholesterol esters (compounds), phospholipids and triglycerides. They are transported in the blood as part of large molecules called lipoproteins.
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastro-intestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders. More information is available about the company at www.intelgenx.com.
FORWARD LOOKING STATEMENTS:
This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K for the fiscal year ended December 31, 2008, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has neither approved nor disapproved the contents of this press release.
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)