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IntelGenx (IGX.V) Announces Successful Pre-NDA Meeting for Anti-Migraine Film

Discussion in 'Canadian Stocks' started by mickymoose99, Nov 8, 2012.

  1. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGX.V) Announces Successful Pre-NDA Meeting for Anti-Migraine Film


    SAINT LAURENT, Quebec, Nov. 8, 2012 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx", "the Company") today announced that the Company concluded a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to its novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT® orally disintegrating tablets.

    The purpose of the meeting was to confirm the adequacy of the clinical, non-clinical and CMC data for the Company's proposed 505(b)(2) NDA submission, which the Company intends to file in the first quarter of 2013, as previously announced.

    Maxalt-MLT® is a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt® grew 16% to $639 million in 2011. The thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (TASE:RDHL) using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.

    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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
     
  2. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGX.V) Reports Third Quarter 2012 Results and Highlights Recent Developmen

    IntelGenx (IGX.V) Reports Third Quarter 2012 Results and Highlights Recent Developments


    SAINT LAURENT, Quebec, Nov. 13, 2012 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx") today announced financial results for the three and nine month periods ended September 30, 2012 and highlighted recent business developments. All amounts are in U.S. dollars, unless otherwise stated.

    "We are very excited that our first FDA-approved product, Forfivo XL™, has been launched in the USA in early October by our partner Edgemont Pharmaceuticals. We believe that ForFivo XL™, as the only single tablet 450mg bupropion HCl available in the U.S., will be a valuable tool for physicians in their management of patients with major depressive disorders," stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "In addition, following the positive pivotal bioequivalence results announced last quarter for our anti-migraine VersaFilm product, we are pleased to confirm that a recent pre-NDA meeting with FDA confirmed that we remain on track to file our 505(b)(2) NDA submission in the first quarter of 2013. This product, along with our Par project, is our top pipeline priority for the immediate future."

    Recent Developments:

    Forfivo XL™

    Subsequent to the end of the third quarter, on October 9, 2012 we announced the commercial launch of Forfivo XL™ in the USA.

    Forfivo XL™ is indicated for the treatment of Major Depressive Disorder (MDD) and is the only extended-release bupropion HCl product to provide a once-daily, 450mg dose in a single tablet. The active ingredient in Forfivo XL is bupropion, the same active ingredient used in the well-known antidepressant product: Wellbutrin XL®. Until now, patients in the US requiring a 450mg dose of bupropion HCl have been taking multiple tablets to achieve their 450mg dose requirement. With Forfivo XL™ now available in the US, these patients can simplify their dosing regimen to a single Forfivo XL tablet, once-daily.

    Forfivo XL™ was developed by IntelGenx and is the Company's first U.S. Food and Drug Administration ("FDA") approved product, approved by the FDA on November 10, 2011. Forfivo XL™ is being marketed in the United States under the terms of a license agreement between IntelGenx and Edgemont Pharmaceuticals. The commercialization of Forfivo XL™ triggers launch-related milestone payments for IntelGenx of up to $4.0 million, and additional milestones upon achieving certain sales and exclusivity targets of up to a further $23.5 million. IntelGenx will also receive tiered double-digit royalties on net sales of Forfivo XL™.

    Anti-migraine VersaFilm (rizatriptan)

    Subsequent to the end of the third quarter, on November 8, 2012 we announced the successful conclusion of a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to our novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT® orally disintegrating tablets.

    The purpose of the meeting was to confirm the adequacy of the clinical, non-clinical and CMC data for the Company's proposed 505(b)(2) NDA submission, which we intend to file in the first quarter of 2013, as previously announced.

    Maxalt-MLT® is a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt® grew 16% to $639 million in 2011. Our thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (TASE:RDHL) using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.

    Financial Results:

    We had cash of $2.8 million as at September 30, 2012, which represents a decrease of approximately $0.7 million from our cash position of $3.5 million as at December 31, 2011 and is $0.4 million below our cash position of $3.2 million at the end of June 2011. In the first nine months of 2012 we used cash of $1.8 million and $0.2 million for operating activities and investments respectively, which was partly offset by the generation of $1.0 million in cash from changes in assets and liabilities, together with $0.3 million in cash from the exercise of warrants.

    Revenue and other income was $0.1 million in the first nine months of 2012, compared with $0.1 million in the first nine months of 2011.

    Total expenses were $2.0 million in the first nine months of 2012, compared with $1.9 million in the same period of 2011.

    The net loss was $1.8 million in the first nine months of 2012, compared with $1.8 million in the first nine months of 2011, and the basic and diluted loss per share of $0.04 in the first nine months of 2012 is equal to the basic and diluted loss per share in the same period of 2011.
     
  3. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGX.V) Grants Stock Options

    IntelGenx (IGX.V) Grants Stock Options

    SAINT LAURENT, Quebec, Dec. 7, 2012 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. ("IntelGenx") (TSX-V:IGX) (OTCQX:IGXT) announced today that the Company's board of directors granted options to acquire 55,000 common shares effective December 4, 2012. All options were granted under the 2006 Stock Option Plan as amended, with an exercise price of C$0.60 and expire in five years. All options vest over a period of two years at the rate of 25% every six months.

    Of the total stock options granted, 30,000 were granted to the CEO and President, Horst G. Zerbe and 25,000 to the CFO, Paul A. Simmons
     
  4. mickymoose99

    mickymoose99 Member

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    IntelGenx Appoints Rajiv Khosla RPh, PhD, MBA

    IntelGenx Appoints Rajiv Khosla RPh, PhD, MBA

    SAINT LAURENT, Quebec, Dec. 11, 2012 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company") today announced that Rajiv Khosla RPh, PhD, MBA has joined its management team in a senior consulting capacity effective January 1, 2013.

    "I am very proud and excited to welcome Rajiv to our management team," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Rajiv brings a wealth of experience and expertise from a distinguished career in the pharmaceutical industry." That experience includes VP Business Development at Biovail Corporation; VP and General Manager, Pharmaceutical, at Sensient Technologies, and Senior Business Director, Healthcare, at ICI Group.

    "Dr. Khosla's business development experience and record of leading growth in the sector are key assets as IntelGenx moves forward," Dr. Zerbe said, noting that Dr. Khosla also has deep knowledge in drug delivery systems.

    Initially, Dr. Khosla will assist IntelGenx with strategic operations, business development activities and provide advice related to IntelGenx' current and future pharmaceutical project development. He will also play an important role in the Company's ongoing succession planning. It is expected that on April 1, 2013, Dr. Khosla will be appointed to the newly created positions of Chief Operating Officer and Chief Scientific Officer at IntelGenx, subject to successful attainment of Canadian work permit documents.

    Dr. Khosla has served as a member of the IntelGenx Board of Directors, where Dr. Zerbe said it became clear that his contributions to the future of the Company could be very significant. He will resign his board seat as he begins his new role.

    Most recently, Dr. Khosla was President, Chief Executive Officer and a member of the board of directors of Orasi Medical, a leading provider of clinical neurophysiology biomarkers, focused on the industrialization and standardization of magnetoencephalography (MEG) in central nervous system drug and therapeutic device development. In January 2011, Dr. Khosla founded CEUTEC LLC, a private company that offers a full-service of business development activities to Biotech, Specialty Pharma and Venture Capital/Private Equity Firms.

    From September 2005 to December 2010, Dr. Khosla was Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, Dr. Khosla successfully led the transaction process for over 75 deal opportunities in a variety of therapeutic areas, including the central nervous system, dermatology, women's health, cardiovascular and gastrointestinal, drug delivery, orphan drugs, generics and pipeline partnerships. From 2003 to 2005, Dr. Khosla was Vice President and General Manager, Pharmaceutical, of Sensient Technologies. From 1998 to 2003, Dr. Khosla served as Senior Business Director, Healthcare at ICI Group, where he managed a new worldwide healthcare business.

    Dr. Khosla holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology, completed in 1987. Additionally, Dr. Khosla has an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.
     
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    mickymoose99 Member

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    IntelGenx (IGXT) Submits New Drug Application for Anti-Migraine VersaFilm

    IntelGenx (IGXT) Submits New Drug Application for Anti-Migraine VersaFilm(TM)


    SAINT LAURENT, Quebec, March 27, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx" or the "Company"), a Canadian drug delivery company focusing on oral drug delivery, today announced that, together with its co-development partner RedHill Biopharma ("RedHill"), it has submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for the Company's anti-migraine oral film product, a novel oral thin-film formulation based on its proprietary VersaFilm(TM) technology containing Rizatriptan, the active drug in Merck's Maxalt-MLT(R) orally disintegrating tablets.

    The company had previously announced a successful a pre-NDA meeting with the FDA following the successful completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT(R), a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt(R) 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 Biopharma Ltd. (RDHL) (RDHL) using IntelGenx' proprietary immediate release "VersaFilm(TM)" drug delivery technology.

    IntelGenx' orally disintegrating film consists of a thin (30 -- 50 um) 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 excited with this filing as 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 believe that the product has significant market potential as it is therapeutically equivalent to Maxalt-MLT(R) orally disintegrating tablets, is easy to use, and offers significant cost advantages over orally disintegrating tablets due to the fact that manufacturing costs of orally disintegrating tablets are generally higher than those of orally disintegrating films as they often require lyophilization of the drug and a complicated, and therefore very expensive, packaging system."

    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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
     
  6. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Secures Leadership Succession

    IntelGenx (IGXT) Secures Leadership Succession

    SAINT LAURENT, Quebec, April 24, 2013 (GLOBE NEWSWIRE) -- Horst Zerbe, President and CEO of IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx" or the "Company") today announced that Rajiv Khosla RPh, PhD, MBA has been appointed Chief Operating Officer and Chief Scientific Officer of the Company, effective immediately. Dr. Khosla has been a member of the Company's board of directors for the past two years and, in accordance with the employment agreement, has now relinquished his board position.

    "I am elated that Dr. Khosla has agreed to bring his outstanding leadership abilities and vision to IntelGenx on a full-time basis," Dr. Zerbe said, adding that the appointment is key to the Company's strategic plan for smooth succession, continuity and growth.

    "We have secured the right leadership for the future," Dr. Zerbe said. "Rajiv has a record of success in business development and in leading growth in our sector. Those are essential attributes as IntelGenx moves forward."

    Dr. Zerbe also noted that Dr. Khosla has deep knowledge in drug delivery systems. He is the first COO at IntelGenx. The succession plan will see Dr. Khosla become CEO and President of IntelGenx on January 1, 2014 and for Dr. Zerbe, who built the Company from the ground up, to remain as Chairman of the board of directors and continue to provide expertise in research and development, and manufacturing.

    Since the beginning of this year, Dr. Khosla has been a consulting member of the IntelGenx management team, assisting with strategic operations, business development activities and advising on current and future pharmaceutical project development.

    IntelGenx, a Canadian company, develops drug delivery systems that solve challenges encountered in oral drug delivery, with technologies that improve the performance of a wide variety of pharmaceutical compounds. IntelGenx has developed capacities to tailor drug release profiles and target specific absorption sites to unlock the full therapeutic potential of a drug. It recently submitted a new drug application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its anti-migraine oral film product, a novel oral thin-film formulation based on its proprietary VersaFilm™ technology

    Dr. Khosla has remarkable experience and credentials including, among other senior positions, five years as Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, Dr. Khosla successfully led the transaction process for more than 75 deal opportunities in a variety of therapeutic areas.

    He holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology; an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.

    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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
     
  7. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Reports Q1, 2013 Results and Provides Operational Update

    IntelGenx (IGXT) Reports Q1, 2013 Results and Provides Operational Update

    SAINT LAURENT, Quebec, May 14, 2013 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company") today announced financial results for the quarter ended March 31, 2013 and provided an update on operational developments.

    "The first quarter of 2013 was another busy period at IntelGenx with the recruitment of Dr. Rajiv Khosla and the filing of a 505(b)(2) NDA for our VersaFilm™ rizatriptan for the treatment of migraines," stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Dr. Khosla has agreed to join the Company, initially as COO & CSO and, with effect from January 2014, as CEO. With his track record of success in business development and in leading growth in our sector, I am convinced that we have the right person to manage IntelGenx into the future. The team at IntelGenx pulled together with the team at RedHill to ensure that our NDA was filed before the end of Q1. This was an excellent effort on all sides. We expect the NDA will be subject to a standard review by the FDA, and are optimistic that the review could be completed as early as the first half of 2014."

    Dr. Rajiv Khosla added, "I want to thank Horst and the rest of the board of directors for the opportunity to join the IntelGenx team. Our portfolio of drug delivery technologies could make the company the drug delivery company of choice in the industry."

    Corporate Development Update

    Anti-migraine VersaFilm™ (rizatriptan)

    In March 2013 we announced that, together with our co-development partner RedHill Biopharma Ltd. ("RedHill"), we submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for our anti-migraine oral film product, a novel oral thin-film formulation based on our proprietary VersaFilm™ technology containing rizatriptan, the active drug in Merck & Co. ("Merck's") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012.

    Erectile Dysfunction VersaFilm(TM) (tadalafil)

    In February 2013 we successfully completed a pilot bioequivalence study on our erectile dysfunction VersaFilm(TM) product. In a previous study, we had already demonstrated that we are able to formulate a bioequivalent product. In the recently completed study, we showed that we were additionally able to develop a faster formulation with a significantly shorter Tmax which will address the potential need for a faster tadalafil product. We are in active discussions for the licensing of this product.

    Development and Commercialization Agreement with Par Pharmaceutical, Inc.

    In December 2011 we announced the execution of a co-development and commercialization agreement with Par Pharmaceutical, Inc. ("Par") for a new product utilizing one of our proprietary oral drug delivery platform technologies. This program continues to make progress. For commercial reasons, and in order to protect both Par's and IntelGenx' competitive advantage, the agreement stipulates that all information pertaining to the product, together with financial terms of the agreement, are to remain confidential.

    Antihypertensive VersaTab(TM) product

    We recently completed a pilot bioequivalence study for our antihypertensive project, INT0001, a generic equivalent to a major cardiovascular product, using our proprietary VersaTab(TM) delivery technology. We continue to make progress with the project and, together with our strategic partner, Dava Pharmaceuticals Inc., are working diligently towards the filing of an ANDA with the FDA.

    Leadership Succession

    Subsequent to the end of the quarter, in April 2013 we announced that Rajiv Khosla RPh, PhD, MBA has been appointed Chief Operating Officer and Chief Scientific Officer of the Company. The succession plan will see Dr. Khosla become CEO and President of IntelGenx on January 1, 2014 and for Dr. Zerbe, the founder, to remain as Chairman of the board of directors and continue to provide expertise in research and development, and manufacturing.

    Dr. Khosla has broad experience and credentials including, among other senior positions, five years as Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, Dr. Khosla successfully led the transaction process for more than 75 deal opportunities in a variety of therapeutic areas.

    He holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology; an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.

    Financial Results:

    Cash of $2.2 million as at March 31, 2013 improved by $0.1 million compared with cash of $2.1 million as at December 31, 2012.

    Accounts receivable decreased by $1.1 million, from $1.3 million as at December 31, 2012 to $0.2 million as at March 31, 2013. Included in this decrease is the receipt of the milestone payment related to the launch of Forfivo XL™.

    Revenue of $0.2 million in the first quarter of 2013 consisted of $0.1 million of royalty income and $0.1 million of deferred license revenue, both related to Forfivo XL™. Revenue in the first quarter of 2012 was $0.1 million.

    Total expenses decreased from $0.7 million in the first quarter of 2012 to $0.6 million in the first quarter of 2013. The decrease relates primarily to clinical study costs incurred in the first quarter of 2012 that were not repeated in the first quarter of 2013.

    The net loss decreased from $0.6 million in the first quarter of 2012 to $0.5 million in the first quarter of 2013. The loss per share was consistent at $0.01 in both the first quarters of 2012 and 2013.
     
  8. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Announces FDA Acceptance of New Drug Application for Anti-Migraine V

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


    SAINT LAURENT, Quebec, June 18, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (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(TM) 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(TM) technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT(R) 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 pre-NDA meeting with the FDA following the completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT(R), a leading branded anti-migraine product manufactured by Merck. According to Merck's most recent annual report, sales of Maxalt(R) 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 (RDHL) (RDHL) using IntelGenx' proprietary immediate release "VersaFilm(TM)" drug delivery technology.

    IntelGenx' orally disintegrating film consists of a thin (30 -- 50 um) 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(R) orally disintegrating tablets, is easy to use, and offers significant cost advantages over orally disintegrating tablets."
     
  9. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Announces Submission of ANDA for Buprenorphine/Naloxone Sublingual F

    IntelGenx (IGXT) Announces Submission of ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction



    SAINT LAURENT, Quebec, July 22, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx" or the "Company"), a Canadian drug delivery company focusing on oral drug delivery, today announced that an Abbreviated New Drug Application ("ANDA") has been submitted to the U.S. Food and Drug Administration ("FDA") for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by IntelGenx' U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone(R) (buprenorphine and naloxone) Sublingual Film.

    "We are very excited with this ANDA filing as we believe that this product represents the most significant milestone in the history of our company to date," commented Dr. Horst Zerbe, IntelGenx' President and CEO. "We are very proud of our achievements in completing full development, testing and filing of the product within such a short amount of time following the execution of the development and commercialization agreement with our co-development partner."

    According to IMS Health, U.S. retail sales of Suboxone(R) Sublingual Film were approximately $1.5 billion in 2012.

    In accordance with confidentiality clauses contained in the co-development and commercialization agreement, the specifics of the product description and financial terms remain confidential. IntelGenx will receive a share of the profits of commercialization, in addition to upfront and milestone payments.

    About Suboxone(R)

    The FDA approved Suboxone(R) in October of 2002 for use in the treatment of opioid addiction. Suboxone(R) is a registered trademark of and manufactured by Reckitt Benckiser Pharmaceuticals. Suboxone(R) is composed of the two active ingredients: buprenorphine and naloxone.

    Naloxone is used to block the effect of opioids. Buprenorphine is a partial opioid agonist that stimulates opioid receptors but does not produce the same effects as an opioid. In other words it does not produce a euphoric "high" effect. The combination of these two actives has been shown to be efficacious in managing the treatment of opioid addiction. Suboxone(R) is most often taken sublingually (dissolved under the tongue). Taken properly it can reduce opioid use, help patients to be successfully managed in an addiction rehabilitation program, and depress the symptoms of opioid withdrawal. Suboxone(R) is the most commonly prescribed medication that is administered to patients during the maintenance phase of treatment. Unlike methadone, Suboxone(R) has a lower potential for overdose and abuse. This enables Certified Doctors, in certain circumstances, to prescribe take home supplies of Suboxone(R).

    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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
     
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    Raghuram Selvaraju, Ph.D. MBA, Managing Director, Head of Healthcare Equity Research at Aegis Capital Corp. Gives an Independent Analysis on IntelGenx

    Investment Highlights:

    ■ Buprenorphine / Naloxone Sublingual Film Filed At FDA. Yesterday,
    IntelGenx announced that it had filed for the approval of a sublingual
    (under the tongue) film-based formulation of a buprenorphine / naloxone
    combination product candidate. Buprenorphine, a partial opioid agonist
    derived from thebaine, was originally commercialized under the trade name
    Subutex for the treatment of opiate addiction, including those habits formed
    on drugs such as morphine and heroin. Naloxone, an opioid inverse agonist
    drug that was originally developed to counteract the effects of opioid
    abuse, was combined with buprenorphine to create the follow-up product to
    Subutex, known as Suboxone. Both Subutex and Suboxone were originally
    commercialized by Reckitt Benckiser plc (RBGPF/OTCBB, Not Rated).
    In the wake of the submission of its sublingual buprenorphine / naloxone
    film-based product at the FDA - a product that is the focus of IntelGenx's
    collaboration agreement with Par Pharmaceutical Co. (Private) and that is
    designed to compete directly with Reckitt's Suboxone Film - we reiterate our
    Buy rating and 18-month price target of $3.00 per share on IGXT.

    ■ Film Approval May Take Some Time. Suboxone Film is covered by
    intellectual property (IP) that, according to Reckitt, expires in 2022. Although
    the patent estate on Suboxone itself expired in 2010, Suboxone Film is
    protected by formulation-based IP. In our view, the situation for IntelGenx
    and its partner Par on the buprenorphine / naloxone product candidate is
    likely to be interesting to watch, especially as IntelGenx and Par are not
    the only players in this game. BioDelivery Sciences (BDSI/NASDAQ, Not
    Rated) has also filed for the approval of a soluble buccal (cheek-adhering)
    formulation of buprenorphine and naloxone, which is called BUNAVAIL®.
    The BUNAVAIL® New Drug Application (NDA) was submitted in June
    2013. While we believe that both BioDelivery Sciences along with IntelGenx
    and Par will eventually be able to launch their respective product candidates,
    we also believe that Reckitt will fight to protect its Suboxone Film franchise as
    long as possible. We are cautiously optimistic, however, because a European
    firm called Orexo has recently received approval for an orally-bioavailable
    sublingual tablet formulation of buprenorphine / naloxone.

    ■ Rizatriptan Thin-Film Approval Expected In Early 2014. In March 2013,
    IntelGenx originally reported that it had filed for approval of its rizatriptan
    drug candidate via the 505(b)(2) pathway. The FDA has assigned a formal
    Prescription Drug User Fee Act (PDUFA) approval decision date to the
    drug of February 3, 2014. This implies a standard review process, as we
    anticipated. In our view, while sales of the IntelGenx drug are unlikely to ever
    approach the peak levels achieved by Maxalt, they could exceed $100mm
    annually by the 2020 / 2021 time frame.

    ■ Additional Catalysts Expected Near-Term. We believe that 2013 may be a
    watershed year for IntelGenx, with multiple regulatory submissions filed and
    near-term approvals possible

    Read the full analysis: bit.ly/13dlo3L
     
  11. SmartStocks

    SmartStocks New Member

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    "Time To Revalue IntelGenx - 2 More Products Being Reviewed By The FDA For Approval"

    A Seeking Alpha article written by contributor 'ccamire'

    Source: http://seekingalpha.com/instablog/1...oducts-being-reviewed-by-the-fda-for-approval

    IGXT is a drug delivery company developing improved formulations of approved drugs for North America. IGXT has already succeeded to get one FDA approved drug using its proprietary technology: Late in 2012, Forfivo XL™ (the only single tablet high dose alternative to lower dose multiple tablet Wellbutrin XL® indicated for depression), was launched by Edgemont Pharma in the US. However the success of this small-cap based in Montreal (Canada) stands much deeper given its strong pipeline of products. Let's focus for now on just two new drugs that are now late stage and could be launched within the next 12-18 months.

    IntelGenx has unique skills in developing improved drugs and has been very successful given the amount of capital invested. Investors should not forget that the company has raised less than $15m since its inception in 2003, has one drug approved and two drugs in the waiting room. Investors should also know the odds favors IntelGenx to receive approval for both drugs given reformulated drugs have an overall approval rate >90% compared to new chemical entities or NCEs below 30%.

    First, the announcement this week for a US filing for a generic of Suboxone film (buprenorphine and naloxone for the treatment of opioid addiction.) for a relatively large market should be a wake-up call for investors. The product is likely to be first generic to market in the fast growing market $1.4bn (tablets and film version almost divided equally). It is difficult to predict what Reckitt Benckiser Pharmaceuticals, the brand manufacturer, will do given its sizeable contribution to profits for the company. Currently patients must be medicated 3x/day; therefore an annual treatment between $4,300- $7,700 depending on the dose. In recent years, the market has shifted from tablets to film formulation to reduce side effects and be cheaper, which is good news for IGXT. Therefore the potential for this product could be huge given that film revenues have increased by 50% versus the prior year. Usually first generic companies capture 60-70% of revenues for the exclusive period (normally six months). Contrary to tablet formulation, where there are many generic companies (>300), makers of film products are very few, probably less than ten in the world. High barriers to entry in formulating this product provide a huge potential upside for IGXT. Therefore we would expect IGXT could enjoy a leadership position beyond six months. Assuming a conservative $1.5bn market at the time of market launch, a 25% price discount and capturing a 50% market, this would means revenues in excess of $500m for its commercial partner. With IGXT being the manufacturer and collecting royalties, this drug itself could add a minimum of $2.00/share in EBITDA. However given the patents on this drug are still valid until 2022, I am not sure when IGXT could launch this drug, but I am sure management has spent time to figure a strategy to reach the marketplace as soon as feasible.

    The other important piece of news (June 18) involved the filing for regulatory approval of a novel anti-migraine drug developed by IGXT. I find this product could be an extremely appealing drug in this market because it offers something really different versus the competition. Even though the US migraine market is close to $2.5bn (all tablet formulations), many patients do not respond to many drugs, are often required to try different treatments and for many are left without any adequate treatments. The advantage of IntelGenx' Anti-Migraine VersaFilm is that it acts faster than probably most drugs and it is also easier to swallow. Commercially this would be the first oral film product for IntelGenx. There are very few oral film drugs on the market; therefore its success will be closely monitored. Assuming a $600m market at the time of market launch, a 25% price discount and capturing a 25% market, this would means revenues in excess of $100m for its commercial partner. With IGXT being the manufacturer and collecting royalties, this drug itself could add $0.40-0.45/share in EBITDA in 2015.

    These drugs are not $1bn potential but they can certainly generate significant revenues with a smaller investment and much lower risks than a typical cancer drug.

    Over the next 2 years, we should expect more drugs that could be launched or in the queue for regulatory approval with the FDA. I believe very few companies have accomplished this feat. We see too many catalysts to ignore the story. Given the company has already delivered on many fronts, drug delivery companies such as IGXT should not be ignored. This is much easier to swallow.
     
  12. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Reports Q2, 2013 Results and Corporate Development Highlights

    IntelGenx (IGXT) Reports Q2, 2013 Results and Corporate Development Highlights



    SAINT LAURENT, Quebec, Aug. 8, 2013 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx") today announced financial results for the three and six months ended June 30, 2013 and provided an update on operational developments. All amounts are in U.S. dollars, unless otherwise stated.

    "I am very pleased to report that increased revenue, together with a reduction in costs, enabled us to record our first-ever quarterly profit," stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "During the quarter we received notification from the FDA that our NDA submission for our anti-migraine VersaFilm™ product had been accepted for review, with an FDA-assigned PDUFA date of February 3, 2014. Also, shortly after the end of the quarter we announced the filing of an ANDA for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence."

    Corporate Development Update

    ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction:

    Subsequent to the end of the quarter, on July 22, 2013 we announced that an Abbreviated New Drug Application ("ANDA") has been submitted to the U.S. Food and Drug Administration ("FDA") for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by our U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film.

    According to IMS Health, U.S. retail sales of Suboxone® Sublingual Film were approximately $1.5 billion in 2012.

    In accordance with confidentiality clauses contained in the co-development and commercialization agreement, the specifics of the product description and financial terms remain confidential. We will receive a share of the profits of commercialization, in addition to upfront and milestone payments.

    The FDA approved Suboxone® in October of 2002 for use in the treatment of opioid addiction. Suboxone® is a registered trademark of Reckitt Benckiser Pharmaceuticals. Suboxone® contains the two active ingredients: buprenorphine and naloxone.

    NDA for Anti-Migraine VersaFilm™ Oral Film Product:

    On June 18, 2013 we announced that the FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of February 3, 2014 for the review of the our New Drug Application ("NDA") for the marketing approval of our anti-migraine VersaFilm™ oral film product. We had previously announced that, together with our co-development partner RedHill Biopharma Ltd ("RedHill"), we had submitted a 505(b)(2) NDA to the FDA for a novel, oral thin-film formulation, based on our proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The FDA confirmed that our application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.

    Financial Results:

    Cash and cash equivalents improved to $2.3 million as at June 30, 2013 compared with $2.1 million as at December 31, 2012. In the second quarter of 2013 we received $0.6 million from the exercise of warrants and stock options, which was partly offset with cash used by operating activities of $0.3 million, cash used in investing activities of $0.1 million and the effect of foreign exchange on cash of $0.1 million.

    Revenue of $0.7 million in the first six months of 2013 represents a significant increase compared with $0.1 million in the same period of the previous year and consisted of $0.5 million related to the achievement of development milestones for our anti-migraine and opiate addiction products, together with $0.1 million of royalty income and $0.1 million of deferred license revenue, both related to Forfivo XL™. Revenue of $0.5 million was recorded in the second quarter of 2013, compared with $0.0 million in the second quarter of 2012.

    Total expenses decreased from $1.3 million in the first half of 2012 to $1.1 million in the first half of 2013. The decrease relates primarily to clinical study costs incurred in the first half of 2012 that were not repeated in 2013, together with the reversal of costs accrued in 2012 for the technical transfer of activities in preparation for manufacturing of Forfivo XL™, partly offset by increased staff costs. Total expenses decreased from $0.7 million in the second quarter of 2012 to $0.5 million in the second quarter of 2013.

    The net loss decreased from $1.2 million in the first six months of 2012 to $0.4 million in the first six months of 2013, representing an improvement of $0.8 million, or 67%. In the second quarter of 2013 we recorded a net profit of $90 thousand, compared with a net loss of $630 thousand in the same period of the previous year. Although we had a profitable second quarter, we do not anticipate that we will be consistently profitable for the foreseeable future.

    The loss per share improved from $0.02 in the first half of 2012 to $0.01 in the first half of 2013. In the three months ended June 30, 2013 the profit / loss per share was $0.00, compared with a loss per share of $0.01 in the same period of 2012.

    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.
     
  13. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Reports Q3, 2013 Results and Corporate Development Highlights

    IntelGenx (IGXT) Reports Q3, 2013 Results and Corporate Development Highlights


    SAINT LAURENT, Quebec, Nov. 8, 2013 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx") today announced financial results for the three and nine months ended September 30, 2013 and provided an update on operational developments. All amounts are in U.S. dollars, unless otherwise stated.

    Corporate Development Update

    ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction:

    On July 22, 2013 we announced that an Abbreviated New Drug Application ("ANDA") has been submitted to the U.S. Food and Drug Administration ("FDA") for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by our U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film.

    According to IMS Health, U.S. retail sales of Suboxone® Sublingual Film were approximately $1.5 billion in 2012.

    On August 26, 2013 we announced that, in response to filing of the ANDA, we were named as a codefendant in a lawsuit pursuant to Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and 8,017,150, each of which relate to Suboxone® Sublingual Film. We believe the ANDA product does not infringe those or any other patents, and will vigorously defend ourselves in this matter. Since Paragraph IV litigation is a regular part of the ANDA process, we do not expect any unanticipated impact on our already planned development schedule. In accordance with the terms of the co-development and commercialization agreement, the costs of defending this litigation will be borne by Par Pharmaceutical Inc.

    On October 8, 2013 we received confirmation that Actavis plc has filed an ANDA with the FDA seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg. Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited and MonoSol Rx, LLC filed suit against Actavis on October 8, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, including a submission date listed on FDA's Paragraph IV Patent Certifications web site that is consistent with the date of Actavis' ANDA filing, Actavis believes it may be a "first applicant" to file an ANDA for a generic version of Suboxone® Sublingual Film and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

    NDA for Anti-Migraine VersaFilm™ Oral Film Product:

    On June 18, 2013 we announced that the FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of February 3, 2014 for the review of the our New Drug Application ("NDA") for the marketing approval of our anti-migraine VersaFilm™ oral film product. We had previously announced that, together with our co-development partner RedHill Biopharma Ltd ("RedHill"), we had submitted a 505(b)(2) NDA to the FDA for a novel, oral thin-film formulation, based on our proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The FDA confirmed that our application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.

    Forfivo XL®:

    On August 22, 2013 we announced receipt of a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an ANDA to the FDA requesting authorization to manufacture and market generic versions of Forfivo XL® 450 mg capsules in the United States.

    IntelGenx intends to vigorously enforce its intellectual property rights for Forfivo XL® and will pursue all available legal and regulatory pathways in defense of Forfivo XL®, which is currently protected by an issued patent listed in the FDA's Approved Drug Products List (Orange Book).

    Financial Results:

    Cash and cash equivalents improved to $2.6 million as at September 30, 2013 compared with $2.3 million as at June 30, 2013 and $2.1 million as at December 31, 2012. In the third quarter of 2013 we received $0.7 million from the exercise of warrants and we benefitted from the positive impact of foreign exchange on cash of $0.1 million. This was partly offset with cash used by operating activities of $0.4 million and cash used in investing activities of $0.1 million. Year-to-date, we received $1.5 million from the exercise of warrants and stock options, which was partly offset with cash used by operating activities of $0.7 million and cash used in investing activities of $0.3 million.

    Revenue of $0.8 million in the first nine months of 2013 represents a significant increase compared with $0.1 million in the same period of the previous year and consists of $0.5 million related to the achievement of development milestones for our anti-migraine and opiate addiction products, together with $0.1 million of royalty income and $0.2 million of deferred license revenue, both related to Forfivo XL®.

    Total expenses decreased from $2.0 million in the first nine months of 2012 to $1.8 million in the first nine months of 2013. The decrease relates primarily to clinical study costs incurred in 2012 that were not repeated in 2013, together with the reversal of costs accrued in 2012 for the technical transfer of activities in preparation for manufacturing of Forfivo XL™, partly offset by increased staff costs. Total expenses were $0.7 million in the third quarter of 2012 and $0.7 million in the third quarter of 2013.

    The net loss decreased from $1.9 million in the first nine months of 2012 to $1.0 million in the first nine months of 2013, representing an improvement of $0.9 million, or 48%. In the third quarter of 2013 we recorded a net loss of $0.6 million, compared with a net loss of $0.7 million in the same period of the previous year.

    The loss per share improved from $0.04 in the first nine months of 2012 to a loss of $0.02 in the first nine months of 2013. In the three months ended September 30, 2013 the loss per share was $0.01, compared with a loss per share of $0.01 in the same period of 2012.

    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.
     
  14. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Announces Public Offering of $3,500,000 of Common Stock

    IntelGenx (IGXT) Announces Public Offering of $3,500,000 of Common Stock




    SAINT LAURENT, Quebec, Dec. 12, 2013 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (IGXT) (IGX.V) ("IntelGenx"), a drug delivery company focused on the development of novel oral rapidly disintegrating delivery systems including its proprietary VersaFilm(TM) technology, as well as oral controlled-release products, announced today that it has entered into definitive agreements with institutional investors to purchase approximately $3.5 million of securities in a registered public offering. IntelGenx has agreed to sell to institutional investors an aggregate of 7,920,346 shares of its common stock at $0.4419 per share. Additionally, investors will receive warrants to purchase up to 7,920,346 shares of common stock at an exercise price of $0.5646 per share for a term of five years.

    The gross proceeds of the offering are expected to be approximately $3.5 million. Net proceeds, after deducting the placement agent's fee and other estimated offering expenses payable by IntelGenx, are expected to be approximately $3.14 million.

    IntelGenx intends to use proceeds from the offering for capital investment in VersaFilm(TM) manufacturing equipment, manufacturing facility improvements and general corporate purposes.

    H.C. Wainwright & Co., LLC acted as the exclusive placement agent for the transaction.

    The offering is expected to close on or about December 16, 2013, subject to customary closing conditions.

    The securities described above are being offered by IntelGenx Technologies Corp. pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission, or the SEC. A prospectus supplement related to the offering will be filed with the SEC. The securities may only be offered by means of a prospectus. Copies of the prospectus and prospectus supplement can be obtained directly from IntelGenx and at the SEC's website at www.sec.gov or by request at H.C. Wainwright & Co., LLC at placements@hcwco.com
     
  15. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT ) Grants Stock Options

    IntelGenx (IGXT ) Grants Stock Options



    SAINT LAURENT, Quebec, Jan. 9, 2014 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. ("IntelGenx", or the "Company") (IGX.V) (IGXT) announced today that the Company's board of directors granted options to acquire 120,000 common shares under the 2006 Stock Option Plan, as amended. The options were granted to the President and Chief Executive Officer, Dr. Rajiv Khosla in accordance with his employment agreement.

    The options have an exercise price of CAD$0.60 and expire on January 1, 2019. The options granted to Mr. Khosla vest on December 31, 2016
     
  16. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Announces Additional Development and Commercialization Agreement Wit

    IntelGenx (IGXT) Announces Additional Development and Commercialization Agreement With Par Pharmaceutical, Inc. for Two More Products


    SAINT LAURENT, Quebec, Jan. 13, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx" or the "Company"), a Canadian drug delivery company focusing on oral drug delivery, today announced that it has entered into another development and commercialization agreement with Par Pharmaceutical, Inc. ("Par") for two new products utilizing IntelGenx' proprietary oral drug delivery platforms.

    Under the terms of the agreement, Par has obtained certain exclusive rights to market and sell IntelGenx' products in the USA. In exchange IntelGenx will receive upfront and milestone payments, together with a share of the profits upon commercialization. In accordance with confidentiality clauses contained in the agreement, the specifics of the product descriptions, platform technologies and financial terms remain confidential.

    "We are very excited to strengthen our affiliation with Par for the development of two new products," stated Dr. Rajiv Khosla, who took over as President and CEO of IntelGenx with effect from January 1st, 2014. "We view this new agreement not only as testament to the excellent working relationship that developed between the two companies during development of the Buprenorphine/Naloxone Sublingual Film Product, but also as further validation of our oral delivery platforms and our ability to develop novel products."

    "Par is very pleased to expand its commercial relationship with IntelGenx," said Paul V. Campanelli, chief executive officer of Par Pharmaceutical Companies, Inc. "With their innovative technology and talented development team, IntelGenx represents an ideal partner for Par."
     
  17. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) and RedHill Biopharma Receive Complete Response Letter From FDA for

    IntelGenx (IGXT) and RedHill Biopharma Receive Complete Response Letter From FDA for VersaFilm(TM) Oral Film Product for Acute Migraines



    •FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; IntelGenx and RedHill plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks based on available data

    •In light of the increased regulatory clarity, IntelGenx and RedHill plan to rapidly advance ongoing discussions with potential partners for the commercialization of their Anti-Migraine "VersaFilm(TM)" Oral Film Product

    •In addition to pursuing marketing approval in the U.S., IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application later this year

    SAINT LAURENT, Quebec, Feb. 4, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, and RedHill Biopharma Ltd. (RDHL) (RDHL) ("RedHill"), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for their VersaFilm(TM) Oral Film Product for the treatment of acute migraines. The VersaFilm(TM) product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R).

    A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm(TM) product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.

    While continuing to review the FDA's CRL, IntelGenx and RedHill believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks.

    IntelGenx and RedHill have been in active discussions with potential partners for the commercialization of the product and expect to advance these discussions rapidly following FDA's CRL, which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding to the product's safety.

    "We appreciate the thorough review of the product NDA by the FDA. We remain committed to bringing the product to market as quickly as possible and will work closely with the FDA to advance the application and address all questions raised by the FDA," said Rajiv Khosla, IntelGenx' President and CEO and Dror Ben-Asher, RedHill's CEO in a joint statement. "We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks in order to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."

    In addition to pursuing marketing approval in the U.S., and following a positive meeting with the German pharmaceuticals regulation authority "BfArM" in October 2013, IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application for marketing approval of the product in Europe later this year, with Germany as the reference member state under the European Mutual Recognition Procedure.

    About the VersaFilm(TM) Oral Film Product:

    The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R). Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1.6 billion in 20121, and the worldwide direct sales of Merck & Co.'s rizatriptan-based drugs exceeded $600 million in 20122.

    The product is based on IntelGenx' proprietary "VersaFilm(TM)" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea - approximately 80% of the total migraine patient population3.

    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, insomnia, 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.
     
  18. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Achieves Positive Bioequivalence Results for Erectile Dysfunction Ve

    IntelGenx (IGXT) Achieves Positive Bioequivalence Results for Erectile Dysfunction VersaFilm(TM) Tadalafil Product



    SAINT LAURENT, Quebec, Feb. 24, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced the completion of a pilot biostudy with its proprietary VersaFilm(TM) tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug (RLD) tadalafil product.

    This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm(TM) tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm(TM) tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.

    "The completion of this pilot biostudy confirms that we can continue the development of our VersaFilm(TM) tadalafil product," said Rajiv Khosla, IntelGenx' President and CEO. "We now plan to progress this project, leading to a pivotal bioequivalence study, with the objective of filing a 505(b)(2) NDA with the U.S. Food and Drug Administration."
     
  19. mickymoose99

    mickymoose99 Member

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    IntelGenx (IGXT) Announces Receipt of Two Additional U.S. Patent Allowances Related

    IntelGenx (IGXT) Announces Receipt of Two Additional U.S. Patent Allowances Related to Proprietary Technology



    SAINT LAURENT, Quebec, Feb. 26, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced that it has received a Notice of Allowance ("NOA") from the United States Patent and Trademark Office for U.S. Patent Application Serial No. 11/647,033 entitled "Multilayer tablet" which covers the technology used in our hypertension product currently under development. A second NOA has been received for U.S. Patent Application Serial No. 11/782,838 entitled "Controlled-release pharmaceutical tablets" which is related to the drug delivery technology used in Forfivo XL(R), IntelGenx' first FDA-approved product currently commercialized in the U.S. These two NOA's conclude the examination of each U.S. patent application and will result in the issuance of two U.S. patents after administrative processes are completed.

    "These two additional NOA's in the U.S. represent yet another important expansion of IntelGenx' patent estate as well as demonstrating the innovative design of our drug delivery technologies," said Rajiv Khosla, IntelGenx' President and Chief Executive Officer. "Our goal is to protect the innovation and commercial potential of the products developed at IntelGenx and these NOA's further strengthen our proprietary position."
     
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    mickymoose99 Member

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    IntelGenx (IGXT) and RedHill Biopharma Submit Response to FDA CRL for VersaFilm(TM) P

    IntelGenx (IGXT) and RedHill Biopharma Submit Response to FDA CRL for VersaFilm(TM) Product for Migraines


    SAINT LAURENT, Quebec, March 3, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage drugs, that they submitted a response to the Complete Response Letter ("CRL") of the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") for their VersaFilm™ Oral Film Product for the treatment of acute migraines.

    The companies previously reported on February 4, 2014 that they received the FDA's CRL which raised questions primarily related to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. The FDA's CRL did not raise any questions or deficiencies relating to the anti-migraine VersaFilm™ product's safety and did not require additional clinical studies. IntelGenx and RedHill believe that their response to the FDA addresses all the issues raised in the CRL.

    IntelGenx and RedHill will continue working with the FDA on the continuing review of the anti-migraine VersaFilm™ NDA, and will provide additional updates as and when applicable.
     
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