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I work for the pharma industry for 20 years and for the last 10 years I have worked as a sell-side analyst and investment banker in healthcare
  • New Prescriptions For Easy-to-swallow Drugs 16 comments
    Aug 14, 2012 9:35 AM | about stocks: IGXT

    Because more than 50% of currently marketed drugs are given as tablets or capsules, compliance has been an issue, mainly due to the number of tablets to be taken, the need to take water, poor taste, and difficulty to swallow. The innovator drug companies such as Pfizer, Merck, Abbott (I know I worked there) have never really paid much attention on how many pills you needed to take every day. Instead the race to be first to market has left patients scrambling with side effects and multiple other problems too long to list. For more than a decade, drug delivery technology companies have developed smarter, more efficient, and convenient drugs that really improve the life of those who need to take drugs on a regular basis. Reformulated drugs mean improved efficacy, safety and convenience.

    IntelGenx Technologies Corp. (OTCPK:IGXT) is a drug delivery company engaged in developing a dozen reformulated drugs using novel delivery technologies. Founded in Montreal (Canada), the company has developed three core technologies: VersaFilm, VersaTab and AdVersa. These technologies have produced two approved products and ten others (see table) at different stages of development.

    The business model is low cost; develop a product until proof of concept, find a partner and collect upfront payments, sales milestones and royalties. The advantages for developing reformulated drugs are that it takes 1-2 years from bench to partnership status, and less than $1m for each. Clinical development costs are very low because in most cases, only phase 1 studies are required. Using the 505(b)(2) regulatory approval process to obtain FDA approval, the company needs to complete two human clinical trials (one pilot and one pivotal) and then file for regulatory approval, which is usually achieved in less than one year.

    Even though there are over 100 drug delivery companies worldwide, some have technologies that others don`t. Most companies have only been able to work on one, two or three products at the same time. IGXT has been much more productive and successful than others. The success of any reformulated drug is about market timing, end-user cost and efficacy/safety benefit.

    IGXT's most differentiated technology is certainly the wafer or oral film (VersaFilm). The film technology has been around for more than 20 years; however fewer than five companies in the world have succeeded in producing only OTC products (allergy, mouth freshener). Film technology allows drugs to be released "almost instantly" in the buccal area where small blood vessels provide a direct conduit to the bloodstream for drugs to be absorbed. This technology is important for a number of treatments where a fast onset of action is needed such as migraine. Migraine is a US$4bn worldwide market widely lead by triptans. All the drugs (branded and generics) sold are tablet formulations which require 15 minutes or more to show any clinical effect. By then symptoms would be so severe that patients might not be able to work or function until symptoms disappear. If you know someone who suffers from migraines then you know that time is of the essence. The migraine film developed by IGXT achieves bioavailability within 5 minutes which is a good reason why this could be a strategic advantage. I believe this product offers a premium advantage to patients and is convenient to use because you don't need water to take the drug. The instant delivery film has distinct advantages over existing fast dissolving oral tablets, which make it the application system of choice for indications requiring an immediate onset of action, like migraine, motion sickness, nausea, erectile dysfunction, or seasonal allergies.

    In tablet formulation, the company has two technologies (VersaTab and AdVersa) that produced two approved drugs: prenatal vitamin and Forfivo (a high-dose version of Valeant's Wellbutrin XL, the only 450mg in the world).

    Some key points to consider about IGXT:

    · All of the drugs are developed based on the two clinical trials: pilot and pivotal bioavailability, which usually cost less than $1m each.

    · 10 products in development to hit the market between now and 2016 . Compared to an approval rate of ~30% for New Chemical Entities (preclinical to market), reformulated drugs get approved in more than 90% of cases.

    · IGXT is developing drugs and therefore will not engage in high expenses such as marketing and sales; it prefers to partner.

    · The film technology is offering major advantages in treating a wide range of diseases.

    Time to market (from research to commercial stage) is usually less than 3 years: from lab to market

    Company is expected to become profitable in 2013

    With management actually having a large stake (~25%) in IGXT's success, versus a large salary, management is sending a strong message of confidence in its own company to the market.

    I have been tracking the company for the last five years and I must say they have done some very good things with very little money. Having raised ~$13m since 2007 and with expectations to break even in the next 12 months, I think very few companies have accomplished so much with so little.

    If everything goes well with the company's tech platform, and they are able to attract the right commercial partners, I think the company could achieve revenues of $50m in the next three years. With only a dozen people in place and 50m shares outstanding , this means a high EPS. The market for reformulated drugs has produced significant success, if you can remember what Biovail did with Wellbutrin achieving end-user revenues of $1.5bn and collecting 25-30% in revenues.

    Success does not have to be quiet, it needs to be highlighted.


    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Stocks: IGXT
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Comments (16)
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  • JonArquetta
    , contributor
    Comments (4) | Send Message
     
    How can you say anything positive about this company when you said regarding Spectrum "Every article I read here is about the possibility of being acquired. Big pharma dont have time for 2nd generation drugs or improved formulation/delivery. Big pharma wants NCE."

     

    How is IGXT different?
    15 Aug 2012, 09:48 AM Reply Like
  • ccamire
    , contributor
    Comments (30) | Send Message
     
    Author’s reply » IGXT is not looking to be acquired
    they are looking to develop improved drugs and they can make money in the process for the company and shareholders; just like Spectrum is doing.
    IGXT is good at developing drugs at the right market cycle timing. I dont know why every company should be acquired to make money for investors
    15 Aug 2012, 10:14 AM Reply Like
  • JonArquetta
    , contributor
    Comments (4) | Send Message
     
    you say "Big pharma dont have time for 2nd generation drugs or improved formulation/delivery" - this is what you say IGXT do.

     

    Are you saying IGXT will always be a small fish or that it is doomed to failure?
    15 Aug 2012, 02:27 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    IGXT is not going to be "acquired". IGXT is starting to be profitable this year (finally). Everything is working great for them. Why they would let somebody else take their $$$ now? This was possibility long time ago, when funding was needed.
    24 Apr 2013, 07:07 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    are you stupid or you just play one?
    24 Apr 2013, 07:09 PM Reply Like
  • JonArquetta
    , contributor
    Comments (4) | Send Message
     
    IGXT never deliver. I have owned this stock and have always been disappointed by Zerbe's consistent failure to meet the milestones that he publishes on the corporate presentation. What kind of a company isn't even able to commercialize its lead product after it has been approved over 12 months ago!

     

    This company is run by a guy with a history of absolute failure. Zerbe seems to have bankrupted his prior company and never denies the question. Zerbe should call it a day.

     

    IMO IGXT is a company on a downward spiral.
    15 Aug 2012, 09:49 AM Reply Like
  • garypalys
    , contributor
    Comments (100) | Send Message
     
    I'm not sure where you come up with Forfivo XL being approved over 12 months ago. Fact is, it was approved about 9 months ago and is expected to be launched next month!

     

    You obviously have no idea what you're talking about, and are probably just an angry trader who took a loss!

     

    Intelgenx is a good company that has had a dramatic disconnect from the market for a long time. IMO, things are about to change!
    15 Aug 2012, 04:27 PM Reply Like
  • garypalys
    , contributor
    Comments (100) | Send Message
     
    So, now in hindsight, that was 11 months from approval to launch... IGXT delivered!
    10 Oct 2012, 04:20 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    So just sell your shares and shut up! Who cares what do you think? You came here to bash so you can buy low? Seems to me you trying to do exactly that. BTW Zebre will resign from CEO post. Read today release before you post something like this. Koshla will be new CEO.
    24 Apr 2013, 07:11 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    Ohh brother....other smartie. Forfivo is already on the market.

     

    Edgemont Pharmaceuticals announced that Forfivo XL (bupropion HCl extended-release tablets) is now available nationwide for the treatment of major depressive disorder (MDD). Forfivo XL, an aminoketone, is the only extended-release bupropion HCl 450mg product as a single tablet. Forfivo XL is bioequivalent to three tablets of Wellbutrin XL 150mg (GlaxoSmithKline).

     

    You calling this guy about not having an idea...well it makes you to look kinda stupid.
    24 Apr 2013, 07:15 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    ohhh this is old post...sorry. I'm the stupid one.
    24 Apr 2013, 07:25 PM Reply Like
  • ccamire
    , contributor
    Comments (30) | Send Message
     
    Author’s reply » Most companies take 6-9 months to have their products available on the market unless you spent ton of money to be ready ahead of time.
    Look around the industry to see what is being done in terms of how much effort and money is required to bring drugs to market. In general companies takes 10 years and over $100m to launch new products
    15 Aug 2012, 10:18 AM Reply Like
  • JonArquetta
    , contributor
    Comments (4) | Send Message
     
    This company is run by a guy with a history of absolute failure. Zerbe seems to have bankrupted his prior company and never denies the question. Zerbe should call it a day.

     

    Why should we expect anything different?
    15 Aug 2012, 02:27 PM Reply Like
  • zman4money
    , contributor
    Comments (3) | Send Message
     
    This is seriously such a GREAT article. It perfectly outlines IGXT. And for those bashing Zerbe, he has about 8 million dollars worth of IGXT stock. If the stock tumbles, so does his wealth so I trust in a CEO with skin in the game.

     

    Once again great article. Long at 0.58
    15 Aug 2012, 03:56 PM Reply Like
  • crookedneck
    , contributor
    Comments (160) | Send Message
     
    The fact is that IGXT has followed through with everything they have presented to date. The fact is that some traders bought in before IGXT got approval for ForFivo XL hoping to make a quick flip on approval and since that didn't happen due to the heavy short interest they blame everything on the company. The fact is that IGXT pps has held up very well over the past 9 months.

     

    I am glad they are taking the necessary time to get everything in order before bringing ForFivo XL to market and delays like this happen all the time in this arena. The original projected date of launch was a best estimate and just because there is a slight delay does not mean the company or the CEO are not doing their job.

     

    I am all for differing opinions, but to read such comments from a disgruntled investor who knows absolutely nothing about the pharmaceutical business is a pure waste of my time.

     

    IGXT has everything coming together now and they are getting noticed and the pps is moving up and their chart looks great and either an impatient investor sold too early for a small loss or they shorted IGXT and are very worried, as they should be. The facts speak for themselves and I like what I see!

     

    Cheers!
    15 Aug 2012, 11:51 PM Reply Like
  • yzzycz
    , contributor
    Comments (174) | Send Message
     
    IGXT is one of the stock you wana retire with. Buy now till is cheap. Look at Market Cap. It is so low you will not believe it. Why? Because media never paid attention to IGXT and Dr. Zebre is more Dr. than CEO with ability to atract investors. In future he will be replaced with Dr. Khosla
    Dr. Khosla was recently named President, Chief Executive Officer and a member of the board of directors of Orasi Medical, a leading provider of clinical neurophysiology biomarkers, which is 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. During his tenure at Biovail, 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 held the position of 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 possesses a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology, which he completed in 1987. Additionally, Dr. Khosla holds an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is also a registered pharmacist in the UK.

     

    Little check up on him. Massive experience, helped many to go up.
    24 Apr 2013, 07:22 PM Reply Like
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