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

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

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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 ...

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.”

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

    • IntelGenx Announces FDA Acceptance of New Drug Application for Anti-Migraine VersaFilm™ Oral Film ProductSAINT LAURENT, QUEBEC, June 18, 2013 - IntelGenx Corp. (TSX-V: IGX) (OTCQX:IGXT) (“IntelGenx”, or the “Company”) today announced that the U.S. Food and DrugAdministration (“FDA”) has assigned a Prescription Drug User Fee Act (“PDUFA”) action dateof February 3, 2014 for the review of the Company’s New Drug Application (“NDA”) for themarketing approval of IntelGenx’ Anti-Migraine VersaFilm™ oral film product.The Company had announced on March 27, 2013 that, together with its co-development partnerRedHill Biopharma Ltd (“RedHill”), it had submitted a 505(b)(2) NDA to the FDA for theCompany’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 drugin Merck & Co (“Merck”) Maxalt-MLT® orally disintegrating tablets. The FDA confirmed thatIntelGenx’ application is sufficiently complete to permit a substantive review in accordance withthe FDA’s “standard” classification process.IntelGenx had previously announced a successful a pre-NDA meeting with the FDA followingthe completion of a bioequivalency study demonstrating that its oral film product isbioequivalent with Maxalt MLT®, a leading branded anti-migraine product manufactured byMerck. According to Mercks most recent annual report, sales of Maxalt® were $638 million in2012. 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 whichdisintegrates rapidly upon oral administration, thereby releasing the active drug Rizatriptan andmaking 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 arevery pleased with the FDA’s confirmation that our anti-migraine film application has beenaccepted for review. We believe that our Rizatriptan film is the first oral film product for thetreatment of migraine for which a 505(b)(2) NDA has been submitted to FDA. We consider thatthe 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 orallydisintegrating tablets.”About IntelGenx:
    • IntelGenx is a drug delivery company focused on the development of oral controlled-releaseproducts as well as novel rapidly disintegrating delivery systems. IntelGenx uses its uniquemultiple layer delivery system to provide zero-order release of active drugs in the gastrointestinaltract. IntelGenx has also developed novel delivery technologies for the rapid delivery ofpharmaceutically active substances in the oral cavity based on its experience with rapidlydisintegrating films. IntelGenx development pipeline includes products for the treatment ofindications such as severe depression, hypertension, erectile dysfunction, migraine, CNSindications, 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 andbusiness prospects that involve substantial risks and uncertainties. Statements that are not purelyhistorical are forward-looking statements within the meaning of Section 21E of the SecuritiesExchange 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 circumstancesand are generally identified by the words "may," "expects," "anticipates," "intends," "plans,""believes," "seeks," "estimates," "could," "would," and similar expressions. All forward lookingstatements are expressly qualified in their entirety by this cautionary statement. Because theseforward-looking statements are subject to a number of risks and uncertainties, IntelGenx actualresults could differ materially from those expressed or implied by these forward lookingstatements. Factors that could cause or contribute to such differences include, but are not limitedto, those discussed under the heading "Risk Factors" in IntelGenx annual report on Form 10-Kfor the fiscal year ended December 31, 2012, filed with the United States Securities andExchange Commission and available at www.sec.gov, and also filed with Canadian securitiesregulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any suchforward-looking statements.Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved thecontents of this press release.CONTACT:Dr. Horst G. Zerbe,President and CEOIntelGenx Technologies Corp.T: +1 514-331-7440 (ext. 201)F: +1 514-331-0436
    • horst@intelgenx.comwww.intelgenx.com