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Novavax, Inc. Message Board

  • medicalstarv medicalstarv Jun 17, 2013 11:52 AM Flag

    (IGXT) MCap $28 M/ Price 0.55 /NDA acceptance this Week/ 10 Drugs in Late Stage !!!

    unknown gem with brutal upside Potential........IGXT´s Monster Pipeline :

    Product ......Application......... Status of Development

    INT0004/2006 Antidepressant -- US launch in 4Q 2012

    INT0008/2007 Migraine -- Submit NDA in March 2013

    INT0007/2006 Erectile Dysfunction -- NDA filing later in 2013

    INT0001/2004 CHF (Coronary Heart Failure), Hypertension -- ANDA filing later in 2013

    INT0027/2011 Undisclosed Partnered with Par Pharma -- ANDA filing later in 2013

    INT0020/2010 Insomnia -- in Pivotal Study

    INT0024/2010 Idiopathic pulmonary fibrosis -- in Pivotal Study

    INT0028/2011 Cancer pain (cannabinoid) --in Pivotal Study

    INT0030/2011 Animal health -- in Pivotal Study

    INT0031/2012 Benign prostatic hyperplasia --in Pivotal Study

    .-.

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    • Good News is Out today guys

      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."

      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.

 
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