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Ironwood Pharmaceuticals, Inc. Message Board

galaberge 12 posts  |  Last Activity: May 27, 2016 8:09 AM Member since: Mar 5, 2002
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  • KTOV an innovative biopharmaceutical company focused on late-stage drug development, today announced the completion of manufacturing by Dexcel Pharma of pivotal batches required for registration of KIT-302 with the U.S. Food and Drug Administration (FDA). This follows Kitov's announcement in December 2015, that KIT-302's pivotal Phase III trial successfully met its primary efficacy endpoint.

    "We are fortunate to have Dexcel as our manufacturing partner for KIT-302. Dexcel's state-of-the-art manufacturing capabilities enabled us to reach this CMC milestone in record time, and bring KIT-302 one step closer to the NDA submission and marketing approval," stated Kitov CEO Isaac Israel."

    GLTA and see you @$100

    Long and strong KTOV

  • ........The owners won't sell shares if anything they would buy more. "

    GLTA and see you @$20

    Sentiment: Strong Buy

  • and 2 hours of trading to go. We should see a good rebound here on New York

    Long and strong KTOV

    Sentiment: Strong Buy

  • JohnWaymack
    Chairman of the Board & Chief Medical Officer
    Dr. John Paul Waymack serves as Chairman of the Board and Chief Medical Officer at Kitov Pharmaceuticals Holdings Ltd since July 11, 2013. Dr. Waymack has over 20 years of experience in the bio-pharma field. Dr. Waymack is a former academic transplant surgeon and a former FDA medical officer, with over 15 years of experience in drug development as a consultant to major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle. During his 10 years of academic career, Dr. Waymack published over 100 scientific essays, mainly in the fields of prostaglandins and immunology. In addition, Dr. Waymack volunteered to the U.S. army, where he was commissioned and served as a Major in the Medical Corp. in the position of Chief of Surgical Research in the U.S. Army’s Institute for Surgical Research. Dr. Waymack was also an associate professor of surgery at the University of Texas Medical Branch and at the University of Medicine and Dentistry of New Jersey.

    Chief Executive Officer, Director
    Mr. Itzhak Israel serves as Chief Executive Officer and Director at Kitov Pharmaceuticals Holdings Ltd since October 31, 2012. Mr. Israel's work experience includes the following roles: Director at Ducant Connecting To Medicine Ltd, Uneri Capital Ltd, Lithotec Medical Ltd, Nextgen Biomed Ltd, Dermipsor Ltd, and at Ofakim Ventures Ltd., Founder and Chief Executive Officer of B Contact Communication, Vice President-Business Development at Ofakim Ventures Ltd and Meytag Hi-Tech Ventures Ltd, and Chief Executive Officer of Dermipsor Ltd, Einspein Medical Ltd.

    Chief Financial Officer, Director


  • Currently there are no combination drugs on the market that treat both osteoarthritis and hypertension together. If approved, KIT-302 would be the first. Kitov indicates that most pain medications, including Celebrex, have worldwide sales of about $2.7 billion as of 2014. In the U.S. alone there are about 27 million people diagnosed with osteoarthritis.

    “KIT-302 has the potential to address the multi-billion dollar market for the treatment of osteoarthritis pain and hypertension with one drug that reduces patients’ risk of suffering a heart attack or stroke, while also reducing cost for payers,” said Paul Waymack, Kitov’s chairman of the board and chief medical officer, in a statement. “There is currently no single medication on the market that treats both osteoarthritis pain and hypertension and thus, KIT-302 will be the only NSAID indicated both to treat pain and to reduce the risk of heart attack, stroke and death.”

    Sentiment: Strong Buy

  • galaberge galaberge May 13, 2016 9:35 PM Flag

    What is DexcelPharma , the partner of KTOV ?

    I quote

    " Dexcel Pharma is Israel’s largest private pharmaceutical
    company. Founded in 1968, we develop, manufacture
    and market value-added branded and generic
    pharmaceuticals. With a diverse product portfolio that
    spans more than 55 branded and generic products in
    over 140 dosage forms, our products are sold in the US,
    the UK and Germany, via subsidiaries and through a
    trusted network of partners in more than 30 countries worldwide."

    Long and strong KTOV

  • I quote :

    "On April 1, 2014 Kitov entered into a strategic agreement with Dexcel Ltd. for the development of the formulation of KIT-302 and the subsequent manufacture of adequate supplies of KIT-302 to submit a New Drug Application (NDA) to the FDA. The agreement calls for Dexcel to develop the final formulation of the drug, including chemical development, analytical methods and validation, stability testing, and production of batches for pharmacokinetics and bioequivalence studies and scale-up for submission of the NDA.

    Kitov will pay Dexcel $2 million in cash and $1.5 million in newly issued shares of Kitov in exchange for these services, based on milestones during the development and manufacturing period.

    In addition, Dexcel will pay Kitov $500,000 in exchange for a right of first negotiation with regard to future marketing rights for KIT-302 and for an option to negotiate the future commercial manufacture of KIT-302 .
    Dexcel is a global pharmaceutical company active in more than 30 countries including the U.S., the U.K., and Germany. Dexcel’s portfolio includes some 55 drug products, both branded and generic, and Dexcel produces some 5 billion tablets and capsules in its Israeli manufacturing facilities, which meet cGMP standards with routine oversight by the FDA " (see the link "
    " evaluategroupDOTcom/Universal/ViewDOTaspx?type=Story&id=516109 "

    So forget about the fools like " matt2400 " and "hitdahomerun " with their wrong statements.

    GLTA and long and strong KTOV

  • Michael S. Okun, MD, also author of the Parkinson bestseller, Parkinson's Treatment: 10 Secrets to a Happier Life, is considered a world's authority on Parkinson's disease treatment, and his publications provide a voice and an outlet to empower people living all over the world. He is currently Administrative Director and Co-director of the University of Florida Center for Movement Disorders and Neurorestoration. The center he runs is unique in that it is comprised of over 45 interdisciplinary faculty members from diverse areas, all of whom are dedicated to care, outreach, education and research. Dr. Okun has been dedicated to this interdisciplinary care concept, and since his appointment as the National Medical Director for the National Parkinson Foundation in 2006, he has worked with the 43 international NPF centers of excellence to help foster the best possible environments for care, research and outreach in Parkinson disease, dystonia, Tourette, and movement disorders. Dr. Okun has been supported by grants from the National Parkinson Foundation, the National Institutes of Health, the Parkinson Alliance, and the Michael J. Fox Foundation for Parkinson’s Disease Research, and he currently runs the online international “Ask The Expert” forums, on the National Parkinson Foundation website. The forum is a free service that answers questions from every continent (except Antartica) and has over 10,000 postings in the last 3 years alone. Dr. Okun has dedicated much of his career to the development of care centers for people suffering with movement disorders, but has also has enjoyed a prolific research career exploring non-motor basal ganglia brain features, and he has participated in pioneering studies exploring the cognitive, behavioral, and mood effects of deep brain stimulation (DBS).....continued

    Sentiment: Strong Buy

  • Reply to

    FDA Panel Backs Approval of Pimavanserin

    by galaberge Apr 20, 2016 4:06 PM
    galaberge galaberge Apr 20, 2016 4:30 PM Flag

    The author is....the Dr. Michael S. Okun himself, NPF's National Medical Director ! He wrote as if it was a done fact.

    Sentiment: Strong Buy

  • Here is an article found in the National Parkinson Foundation

    I quote :" What's Hot in PD?: As a New Drug Gains FDA Approval for Parkinson’s Disease Psychosis (Nuplazid), Should We Fear Using it? "

    Here is the link : " parkinsonDOTorg/find-help/blogs/whats-hot/april-2016 "

    Good reading


    Sentiment: Strong Buy

  • Here is a link stating the purchases of the BB: " edgarDOTsecDOTgov/Archives/edgar/data/1070494/000163859916000776/xslF345X03/doc4_3894DOTxml "


    Sentiment: Strong Buy

  • Reply to

    Baker Brothers are buying again

    by hawkihop1 Apr 2, 2016 5:44 PM
    galaberge galaberge Apr 3, 2016 7:50 PM Flag


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