SAINT LAURENT, QUEBEC, Aug. 12, 2010 (Marketwire) -- IntelGenx Technologies Corp. (TSX VENTURE:IGX) (OTCBB:IGXT) ("IntelGenx") today announced its financial results for the three and six month period ended June 30, 2010 and presented highlights of recent business developments. All figures are in U.S. dollars, unless otherwise stated.
"The first half of 2010 was highlighted by FDA's complete response letter for the NDA for our high-dose bupropion product, CPI-300, and the subsequent meeting with FDA held in June. We were pleased that at this meeting, the Agency supported the clinical plan the company is proposing to address the previously observed food effect and to demonstrate bioequivalency of product manufactured at the new manufacturing site," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We have also been very active on the business development front in 2010, entering into a number of new agreements and expanding on others. These include the increase in ownership of our Relivar product to 50 percent, the potential ownership position in the Pillar5 state-of-the-art manufacturing facility, the letter of intent for the out-licensing of our thin film migraine product, and the acquisition of full ownership of CPI-300 high dose bupropion hydrochloride product."
Antidepressant Tablet (CPI-300):
On May 7, 2010 IntelGenx executed a Project Transfer Agreement ("Agreement") with Cary Pharmaceuticals Inc. ("Cary"), its former development partner, whereby Cary assigned its 50% ownership stake in CPI-300 to IntelGenx. Pursuant to the Agreement, IntelGenx and Cary ("the Parties") have agreed to terminate the Collaborative Agreement entered into in November 2007 and the Parties further agreed that the CPI-300 project will be transferred and assigned to IntelGenx. In addition, Cary has assigned to IntelGenx all rights and interest in the regulatory approvals that Cary has or may have had, including the NDA, and IntelGenx will be responsible for the costs associated therewith. IntelGenx will have full and complete authority with respect to the prosecution and/or amendment of the NDA and the commercialization of the product and/or the technology encompassed in the CPI-300 project. IntelGenx will also assume all obligations to, and responsibility for, the Biovail litigation, including the costs thereof. In addition to certain potential pre-commercialization payments, IntelGenx will pay Cary, upon commercialization of CPI-300, 10% of sales royalties received by IntelGenx and 3% of upfront payments received by IntelGenx should a distribution agreement be signed in the future.
On June 21, 2010 IntelGenx announced that it recently met with the FDA to discuss its response to the Complete Response Letter. The Agency confirmed that it agrees with the clinical plan the company is proposing to address the previously observed food effect and to demonstrate bioequivalency of product manufactured at the new manufacturing site. Based on FDA's recommendations regarding the stability data required to support the new manufacturing site, the company expects to file the amendment to the NDA in the first quarter of 2011.
On April 21, 2010 IntelGenx announced that it has executed a binding term-sheet with RedHill Biopharma Ltd., an Israeli corporation ("RedHill") to co-develop and license IntelGenx' first oral thin film product based upon the Company's proprietary VersaFilm™ technology. The product is intended for the rapid relief of migraine. The term-sheet sets forth the main criteria to be incorporated into a definitive development and license agreement, subject to due diligence, under which RedHill would obtain exclusive world-wide rights to market and sell IntelGenx' rapidly dissolving anti-migraine oral film product. In exchange IntelGenx would receive upfront, milestone, and external development fees totalling up to $2.1 million from RedHill. RedHill will also be responsible for regulatory filing fees, if necessary. Furthermore, upon commercialization of the product, IntelGenx would receive 40% of all proceeds including, but not limited to, all sales milestones and income from the product world-wide.
Manufacturing Partnership and Ownership Position in Manufacturing Facility:
On April 30, 2010 IntelGenx entered into a Memorandum of Agreement ("Agreement") with Pillar5 Pharma Inc. Pursuant to the Agreement, IntelGenx undertakes to use its best efforts to ensure that distributors of IntelGenx' oral solid dose pharmaceutical products developed for commercial production be directed to Pillar5 for purposes of negotiating a manufacturing agreement requiring Pillar5 to manufacture those products. As consideration for this undertaking, Pillar5 issued to IntelGenx 114 voting common shares of Pillar5, representing 10% of the issued and outstanding shares of Pillar5. The shares will be held in escrow and are forfeitable by IntelGenx until Pillar5 achieves certain revenue targets and are subject to restrictions on transfer pursuant to the Agreement. IntelGenx has a right of first refusal in the event of bona fide sale to a third party of all of the shares or substantially all of the assets of Pillar5. Pursuant to the Agreement, IntelGenx has the right to designate a nominee to serve on the board of directors of Pillar5 and Pillar5 has the right to designate a nominee to serve on the board of directors of IntelGenx Technologies Corp.
YEAR-TO-DATE FINANCIAL HIGHLIGHTS:
Cash and cash equivalents at June 30, 2010 of approximately $0.4 million (2009: $0.1 million).
Cash used in first half of 2010 $1.5 million (2009: $0.5 million)
Total Revenue of $0.3 million (2009: $0.7 million).
Total Expenses increased by $0.5 million to $2.0 million (2009: $1.5 million) including $0.7 million related to the Biovail litigation and $0.3 million related to the foreign exchange impact arising from the translation of the Company's operating currency (CAD$) into its reporting currency (US$), partly compensated by reduced R&D expenses of $0.1 million and the reduction of financing fees of $0.4 million following repayment of the convertible debt in Q3, 2009.
The Net Loss widened by $1.0 million to $1.7 million (2009: $0.7 million)
The Basic and Diluted Loss Per Common Share deteriorated by $0.01 to $0.05 (2009: $0.04)
About IntelGenx Corp.:
IntelGenx Corp. 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 gastrointestinal 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' 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' 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' 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' 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' annual report on Form 10-K for the fiscal year ended December 31, 2009, 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
514-331-7440 (ext. 201)