SlideShare a Scribd company logo
1 of 3
IntelGenx Announces FDA Acceptance of New Drug Application for Anti-
Migraine VersaFilm™ Oral Film Product
SAINT LAURENT, QUEBEC, June 18, 2013 - IntelGenx Corp. (TSX-V: IGX) (OTCQX:
IGXT) (“IntelGenx”, or the “Company”) today announced that the U.S. Food and Drug
Administration (“FDA”) has assigned a Prescription Drug User Fee Act (“PDUFA”) action date
of February 3, 2014 for the review of the Company’s New Drug Application (“NDA”) for the
marketing approval of IntelGenx’ Anti-Migraine VersaFilm™ oral film product.
The Company had announced on March 27, 2013 that, together with its co-development partner
RedHill Biopharma Ltd (“RedHill”), it had submitted a 505(b)(2) NDA to the FDA for the
Company’s anti-migraine oral film product. The product is a novel, oral thin-film formulation,
based on IntelGenx’ proprietary VersaFilm™ technology containing Rizatriptan, the active drug
in Merck & Co (“Merck”) Maxalt-MLT® orally disintegrating tablets. The FDA confirmed that
IntelGenx’ application is sufficiently complete to permit a substantive review in accordance with
the FDA’s “standard” classification process.
IntelGenx had previously announced a successful a pre-NDA meeting with the FDA following
the completion of a bioequivalency study demonstrating that its oral film product is
bioequivalent with Maxalt MLT®, a leading branded anti-migraine product manufactured by
Merck. According to Merck's most recent annual report, sales of Maxalt® were $638 million in
2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co-
development and commercialisation agreement with RedHill (NASDAQ: RDHL; TASE: RDHL)
using IntelGenx' proprietary immediate release "VersaFilm™" drug delivery technology.
IntelGenx’ orally disintegrating film consists of a thin (30 – 50 µm) polymeric film which
disintegrates rapidly upon oral administration, thereby releasing the active drug Rizatriptan and
making it available for rapid absorption. The film does not require water for administration.
On announcing the news, IntelGenx' President and CEO Dr. Horst Zerbe commented, “We are
very pleased with the FDA’s confirmation that our anti-migraine film application has been
accepted for review. We believe that our Rizatriptan film is the first oral film product for the
treatment of migraine for which a 505(b)(2) NDA has been submitted to FDA. We consider that
the product has significant market potential as it is therapeutically equivalent to Maxalt-MLT®
orally disintegrating tablets, is easy to use, and offers significant cost advantages over orally
disintegrating tablets.”
About IntelGenx:
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 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' development pipeline includes products for the treatment of
indications such as severe depression, hypertension, erectile dysfunction, migraine, CNS
indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products.
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, 2012, 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 OTCQX has neither approved nor disapproved the
contents of this press release.
CONTACT:
Dr. Horst G. Zerbe,
President and CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1 514-331-0436
horst@intelgenx.com
www.intelgenx.com

More Related Content

More from Viral Network Inc

Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel Specifica...
Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel  Specifica...Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel  Specifica...
Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel Specifica...
Viral Network Inc
 
TNR Gold Investor Presentation
TNR Gold Investor PresentationTNR Gold Investor Presentation
TNR Gold Investor Presentation
Viral Network Inc
 
Highbank Resources - August 2013 Corporate Presentation
Highbank Resources - August 2013 Corporate PresentationHighbank Resources - August 2013 Corporate Presentation
Highbank Resources - August 2013 Corporate Presentation
Viral Network Inc
 
Sierra Metals announces first proven and probable ore reserves at the Bolivar...
Sierra Metals announces first proven and probable ore reserves at the Bolivar...Sierra Metals announces first proven and probable ore reserves at the Bolivar...
Sierra Metals announces first proven and probable ore reserves at the Bolivar...
Viral Network Inc
 
Sierra Metals (TSX.V: SMT) Investor Presentation
Sierra Metals (TSX.V: SMT) Investor PresentationSierra Metals (TSX.V: SMT) Investor Presentation
Sierra Metals (TSX.V: SMT) Investor Presentation
Viral Network Inc
 

More from Viral Network Inc (20)

PTP Feb. 2014 Factsheet
PTP Feb. 2014 FactsheetPTP Feb. 2014 Factsheet
PTP Feb. 2014 Factsheet
 
SponsorsOne Investor Deck
SponsorsOne Investor DeckSponsorsOne Investor Deck
SponsorsOne Investor Deck
 
Altima Resources - 2 Pager
Altima Resources - 2 PagerAltima Resources - 2 Pager
Altima Resources - 2 Pager
 
PTP News - Nov. 14
PTP News - Nov. 14PTP News - Nov. 14
PTP News - Nov. 14
 
Petrichor Energy - Petrichor Closes First Tranche Convertible Debenture Finan...
Petrichor Energy - Petrichor Closes First Tranche Convertible Debenture Finan...Petrichor Energy - Petrichor Closes First Tranche Convertible Debenture Finan...
Petrichor Energy - Petrichor Closes First Tranche Convertible Debenture Finan...
 
Highbank Resources August Corporate Presentation
Highbank Resources August Corporate PresentationHighbank Resources August Corporate Presentation
Highbank Resources August Corporate Presentation
 
Highbank Resources - Highbank Receives Comments on Notice of Work (NoW) Permi...
Highbank Resources - Highbank Receives Comments on Notice of Work (NoW) Permi...Highbank Resources - Highbank Receives Comments on Notice of Work (NoW) Permi...
Highbank Resources - Highbank Receives Comments on Notice of Work (NoW) Permi...
 
Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel Specifica...
Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel  Specifica...Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel  Specifica...
Scientific Study Reveals ReadiDiesel® Meets Petroleum-Based Diesel Specifica...
 
TNR Gold Investor Presentation
TNR Gold Investor PresentationTNR Gold Investor Presentation
TNR Gold Investor Presentation
 
Full Analyst Report: IntelGenx Tech. Rating: Buy. IntelGenx Looking Towards A...
Full Analyst Report: IntelGenx Tech. Rating: Buy. IntelGenx Looking Towards A...Full Analyst Report: IntelGenx Tech. Rating: Buy. IntelGenx Looking Towards A...
Full Analyst Report: IntelGenx Tech. Rating: Buy. IntelGenx Looking Towards A...
 
Calyx Announces Commercial Launch of Higher Yielding Variety of Resonance(R) ...
Calyx Announces Commercial Launch of Higher Yielding Variety of Resonance(R) ...Calyx Announces Commercial Launch of Higher Yielding Variety of Resonance(R) ...
Calyx Announces Commercial Launch of Higher Yielding Variety of Resonance(R) ...
 
Red Eagle Mining - Salman Partners "Accelerating Development at San Ramon-Pot...
Red Eagle Mining - Salman Partners "Accelerating Development at San Ramon-Pot...Red Eagle Mining - Salman Partners "Accelerating Development at San Ramon-Pot...
Red Eagle Mining - Salman Partners "Accelerating Development at San Ramon-Pot...
 
Highbank Resources - August 2013 Corporate Presentation
Highbank Resources - August 2013 Corporate PresentationHighbank Resources - August 2013 Corporate Presentation
Highbank Resources - August 2013 Corporate Presentation
 
IntelGenx Corporate Presentation
IntelGenx Corporate PresentationIntelGenx Corporate Presentation
IntelGenx Corporate Presentation
 
Sierra Metals announces first proven and probable ore reserves at the Bolivar...
Sierra Metals announces first proven and probable ore reserves at the Bolivar...Sierra Metals announces first proven and probable ore reserves at the Bolivar...
Sierra Metals announces first proven and probable ore reserves at the Bolivar...
 
Sierra Metals (TSX.V: SMT) Investor Presentation
Sierra Metals (TSX.V: SMT) Investor PresentationSierra Metals (TSX.V: SMT) Investor Presentation
Sierra Metals (TSX.V: SMT) Investor Presentation
 
Sierra Metals Fact Sheet
Sierra Metals Fact SheetSierra Metals Fact Sheet
Sierra Metals Fact Sheet
 
NioGold - Fiche Technique
NioGold - Fiche TechniqueNioGold - Fiche Technique
NioGold - Fiche Technique
 
Golden Arrow Resources Corporation - Corporate Presentation
Golden Arrow Resources Corporation - Corporate PresentationGolden Arrow Resources Corporation - Corporate Presentation
Golden Arrow Resources Corporation - Corporate Presentation
 
IntelGenx submits New Drug Application for Anti-Migraine VersaFilm(TM)
IntelGenx submits New Drug Application for Anti-Migraine VersaFilm(TM)IntelGenx submits New Drug Application for Anti-Migraine VersaFilm(TM)
IntelGenx submits New Drug Application for Anti-Migraine VersaFilm(TM)
 

Recently uploaded

Future of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
Future of Trade 2024 - Decoupled and Reconfigured - Snapshot ReportFuture of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
Future of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
Dubai Multi Commodity Centre
 
NewBase 24 May 2024 Energy News issue - 1727 by Khaled Al Awadi_compresse...
NewBase   24 May  2024  Energy News issue - 1727 by Khaled Al Awadi_compresse...NewBase   24 May  2024  Energy News issue - 1727 by Khaled Al Awadi_compresse...
NewBase 24 May 2024 Energy News issue - 1727 by Khaled Al Awadi_compresse...
Khaled Al Awadi
 

Recently uploaded (20)

Engagement Rings vs Promise Rings | Detailed Guide
Engagement Rings vs Promise Rings | Detailed GuideEngagement Rings vs Promise Rings | Detailed Guide
Engagement Rings vs Promise Rings | Detailed Guide
 
A Brief Introduction About Jacob Badgett
A Brief Introduction About Jacob BadgettA Brief Introduction About Jacob Badgett
A Brief Introduction About Jacob Badgett
 
Future of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
Future of Trade 2024 - Decoupled and Reconfigured - Snapshot ReportFuture of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
Future of Trade 2024 - Decoupled and Reconfigured - Snapshot Report
 
How to Maintain Healthy Life style.pptx
How to Maintain  Healthy Life style.pptxHow to Maintain  Healthy Life style.pptx
How to Maintain Healthy Life style.pptx
 
Aptar Closures segment - Corporate Overview-India.pdf
Aptar Closures segment - Corporate Overview-India.pdfAptar Closures segment - Corporate Overview-India.pdf
Aptar Closures segment - Corporate Overview-India.pdf
 
PitchBook’s Guide to VC Funding for Startups
PitchBook’s Guide to VC Funding for StartupsPitchBook’s Guide to VC Funding for Startups
PitchBook’s Guide to VC Funding for Startups
 
Event Report - IBM Think 2024 - It is all about AI and hybrid
Event Report - IBM Think 2024 - It is all about AI and hybridEvent Report - IBM Think 2024 - It is all about AI and hybrid
Event Report - IBM Think 2024 - It is all about AI and hybrid
 
Team-Spandex-Northern University-CS1035.
Team-Spandex-Northern University-CS1035.Team-Spandex-Northern University-CS1035.
Team-Spandex-Northern University-CS1035.
 
Hyundai capital 2024 1q Earnings release
Hyundai capital 2024 1q Earnings releaseHyundai capital 2024 1q Earnings release
Hyundai capital 2024 1q Earnings release
 
MichaelStarkes_UncutGemsProjectSummary.pdf
MichaelStarkes_UncutGemsProjectSummary.pdfMichaelStarkes_UncutGemsProjectSummary.pdf
MichaelStarkes_UncutGemsProjectSummary.pdf
 
Copyright: What Creators and Users of Art Need to Know
Copyright: What Creators and Users of Art Need to KnowCopyright: What Creators and Users of Art Need to Know
Copyright: What Creators and Users of Art Need to Know
 
Creative Ideas for Interactive Team Presentations
Creative Ideas for Interactive Team PresentationsCreative Ideas for Interactive Team Presentations
Creative Ideas for Interactive Team Presentations
 
Unveiling Gemini: Traits and Personality of the Twins
Unveiling Gemini: Traits and Personality of the TwinsUnveiling Gemini: Traits and Personality of the Twins
Unveiling Gemini: Traits and Personality of the Twins
 
Stages of Startup Funding - An Explainer
Stages of Startup Funding - An ExplainerStages of Startup Funding - An Explainer
Stages of Startup Funding - An Explainer
 
New Product Development.kjiy7ggbfdsddggo9lo
New Product Development.kjiy7ggbfdsddggo9loNew Product Development.kjiy7ggbfdsddggo9lo
New Product Development.kjiy7ggbfdsddggo9lo
 
بروفايل شركة ميار الخليج للاستشارات الهندسية.pdf
بروفايل شركة ميار الخليج للاستشارات الهندسية.pdfبروفايل شركة ميار الخليج للاستشارات الهندسية.pdf
بروفايل شركة ميار الخليج للاستشارات الهندسية.pdf
 
Elevate Your Online Presence with SEO Services
Elevate Your Online Presence with SEO ServicesElevate Your Online Presence with SEO Services
Elevate Your Online Presence with SEO Services
 
The Truth About Dinesh Bafna's Situation.pdf
The Truth About Dinesh Bafna's Situation.pdfThe Truth About Dinesh Bafna's Situation.pdf
The Truth About Dinesh Bafna's Situation.pdf
 
Toyota Kata Coaching for Agile Teams & Transformations
Toyota Kata Coaching for Agile Teams & TransformationsToyota Kata Coaching for Agile Teams & Transformations
Toyota Kata Coaching for Agile Teams & Transformations
 
NewBase 24 May 2024 Energy News issue - 1727 by Khaled Al Awadi_compresse...
NewBase   24 May  2024  Energy News issue - 1727 by Khaled Al Awadi_compresse...NewBase   24 May  2024  Energy News issue - 1727 by Khaled Al Awadi_compresse...
NewBase 24 May 2024 Energy News issue - 1727 by Khaled Al Awadi_compresse...
 

IntelGenx Announces FDA Acceptance of New Drug Application for Anti- Migraine VersaFilm™ Oral Film Product

  • 1. IntelGenx Announces FDA Acceptance of New Drug Application for Anti- Migraine VersaFilm™ Oral Film Product SAINT LAURENT, QUEBEC, June 18, 2013 - IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (“IntelGenx”, or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has assigned a Prescription Drug User Fee Act (“PDUFA”) action date of February 3, 2014 for the review of the Company’s New Drug Application (“NDA”) for the marketing approval of IntelGenx’ Anti-Migraine VersaFilm™ oral film product. The Company had announced on March 27, 2013 that, together with its co-development partner RedHill Biopharma Ltd (“RedHill”), it had submitted a 505(b)(2) NDA to the FDA for the Company’s anti-migraine oral film product. The product is a novel, oral thin-film formulation, based on IntelGenx’ proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co (“Merck”) Maxalt-MLT® orally disintegrating tablets. The FDA confirmed that IntelGenx’ application is sufficiently complete to permit a substantive review in accordance with the FDA’s “standard” classification process. IntelGenx had previously announced a successful a pre-NDA meeting with the FDA following the completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT®, a leading branded anti-migraine product manufactured by Merck. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co- development and commercialisation agreement with RedHill (NASDAQ: RDHL; TASE: RDHL) using IntelGenx' proprietary immediate release "VersaFilm™" drug delivery technology. IntelGenx’ orally disintegrating film consists of a thin (30 – 50 µm) polymeric film which disintegrates rapidly upon oral administration, thereby releasing the active drug Rizatriptan and making it available for rapid absorption. The film does not require water for administration. On announcing the news, IntelGenx' President and CEO Dr. Horst Zerbe commented, “We are very pleased with the FDA’s confirmation that our anti-migraine film application has been accepted for review. We believe that our Rizatriptan film is the first oral film product for the treatment of migraine for which a 505(b)(2) NDA has been submitted to FDA. We consider that the product has significant market potential as it is therapeutically equivalent to Maxalt-MLT® orally disintegrating tablets, is easy to use, and offers significant cost advantages over orally disintegrating tablets.” About IntelGenx:
  • 2. 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 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' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. 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, 2012, 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 OTCQX has neither approved nor disapproved the contents of this press release. CONTACT: Dr. Horst G. Zerbe, President and CEO IntelGenx Technologies Corp. T: +1 514-331-7440 (ext. 201) F: +1 514-331-0436