Axcan now Aptalis question ??

Discussion in 'Aptalis' started by Anonymous, Jun 7, 2011 at 7:45 PM.

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  1. Anonymous

    Anonymous Guest

    Yes, really, it is known fact.
    As it is a know fact that raw material is manufactured in campaigns; in fact several of them each year. The FDA may have found problems with one batch, maybe the one used for the pivotal studies, and pending clarification or further investigation has rejected Axan application for the drug.

    It may also be that the tests on the final product required by Axan (each company has the liberty to set their own specs) are different from the tests that were required by Eurand, and that may have been a problem with the FDA.

    The complexity of regulatory issues is most often kept very confidential, and we may never know what really went down. But I assure you, the raw material for Zenpep and Ultrase comes from the same bulk manufacturer. As stated in my previous post, Eurand manufactured the bulk medication (from the raw material) for Axcan.

    I am surprised that folks that (I assume) work for this company (now a combination of the previous 2) are not aware of these (publicly available) known facts.

    Feel free to run a search, as I am not sure if I can post links in the forums.
     

  2. Anonymous

    Anonymous Guest

    I was completely under the impression that the FDA was the one holding up Ultrase and approval was just around the corner. Then I discovered this forum and read everything being said by you all. I'm no longer giving Axcan the benefit of the doubt or expecting to see Ultrase back on the market.
     
  3. Anonymous

    Anonymous Guest

    In 2 decades of dealing with the FDA I can tell you for sure that 99.9% of the times it is not the agency that holds up companies, it is the companies that want to cut corners, not play be the rules and thing that they are special.

    Do what the FDA asks for and you are fine. Try to outsmart them, and you pay for it with delays and non-approval letters.

    As simple as that.
     
  4. Anonymous

    Anonymous Guest

    ooops!
    thing = think
     
  5. Anonymous

    Anonymous Guest

    To the OP who is using Ultrase. You said you did not want to get on Zenpep because of stomach pain. Zenpep wasnot approved when Ultrase was on the market, so how could you have tried it? It is a new product, only approved since the FDA requirements went into place. Maybe you can take it without stomach pain. good luck
     
  6. Anonymous

    Anonymous Guest

    I haven't taken it myself, but I know people who are taking it. They tell me how much they hate it. The best guess we can make is that the amount of amylase is nearly twice what it is in Ultrase, and that could be what's causing their pain.
     
  7. Anonymous

    Anonymous Guest

    The amount of misinformation found in this forum is depressing.

    1) The ratio of amylase and protease could vary within the same product from batch to batch.

    2) Each product can have different ratios of the 3 enzymes, even within the same product at different.
    Same examples (form information available on the internet):
    Zenpep: 10,000 USP units of lipase, 17,000 units of protease, and 27,000 units of amylase
    Ultase: 4,500 USP units of lipase, 25,000 units of protease, and 20,000 units of amylase
    Ultrase MT12: 12,000 USP units of lipase, 39,000 units of protease, and 39,500 units of amylase
    Creon: 12,000 USP units of lipase, 38,000 units of protease, and 60,000 units of amylase

    Let’s do some simple math.

    Zenpep:
    1 unit of lipase
    1.7 units of protease
    2.7 units of amylase

    Ultrase:
    1 unit of lipase
    5.5 units of protease
    4.5 units of amylase

    Ultrase MT12:
    1 unit of lipase
    3.25 units of protease
    3.25 units of amylase

    Creon:
    1 unit of lipase
    3.1 units of protease
    5 units of amylase

    Amazing isn’t it?

    As you can see, even taking the same product may expose you to different ratios of the different enzymes. Your (or your friend’s) stomach pains are most likely due to not being able to adjust the dose or not giving the new dose enough time.
     
  8. Anonymous

    Anonymous Guest

    When you commented on the misinformation on this thread I didn't realize you intended to add to the misinformation. I have copied and pasted the following from www.zenpep.com:

    ---------------------DOSAGE FORMS AND STRENGTHS----------------------
    • Capsules: 3,000 USP units of lipase; 10,000 USP units of protease; 16,000 USP units of amylase. Capsules have a white opaque cap and body, printed with “EURAND 3”(3)
    • Capsules: 5,000 USP units of lipase; 17,000 USP units of protease; 27,000 USP units of amylase. Capsules have a white opaque cap and body, printed with “EURAND 5” (3)
    • Capsules: 10,000 USP units of lipase; 34,000 USP units of protease; 55,000 USP units of amylase. Capsules have a yellow opaque cap and white opaque body, printed with “EURAND 10” (3)
    • Capsules: 15,000 USP units of lipase; 51,000 USP units of protease; 82,000 USP units of amylase. Capsules have a red opaque cap and white opaque body, printed with “EURAND 15” (3)
    • Capsules: 20,000 USP units of lipase; 68,000 USP units of protease; 109,000 USP units of amylase. Capsules have a green opaque cap and white opaque body, printed with “EURAND 20”(3)
    • Capsules: 25,000 USP units of lipase; 85,000 USP units of protease; 136,000 USP units of amylase. Capsules have a blue opaque cap and white opaque body, printed with “EURAND 25”(3)


    The example you gave for Zenpep gave the protease and amylase ratios for 5,000 units of Lipase, not 10,000. That makes the ratio of amylase 5.4, not 2.7. Ultrase MT20 has 20,000 units of lipase, 65,000 units of protease (3.25%) and 65,000 units of amylase (3.25%), a far cry from the 109,000 units of amylase (5.45%) in the Zenpep lipase equivalent (protease at 68,000 units or 3.4%). Creon 20 (as posted on www.creon-us.com) has 20,000 units of lipase, 75,000 of protease (3.75%) and 66,400 units of amylase (3.32%). It appears to me that Creon 20 would be a better product to switch to than Zenpep if you had previously taken Ultrase MT 20.
     
  9. Anonymous

    Anonymous Guest


    Now this information is funny!!! I hope there are those other than I that see the tiny little error in this "research."


    Amazing, no?
     
  10. Anonymous

    Anonymous Guest

    Point taken. Next time do this when I have more time instead of rushing it. At least I went the right direction.
    Still goes to show how different products have different ratios of enzymes, my error in transcription notwithstanding.
     
  11. Anonymous

    Anonymous Guest


    The point you make is EXACTLY why there are so many of us who want very much for Axcan to get it's act together and bring Ultrase back to the market.
     
  12. Anonymous

    Anonymous Guest

    Good luck with that.
     
  13. Anonymous

    Anonymous Guest

    Partially true, the FDA also has very limited staff/resources and that often causes delays, as well.
    Also companies don't tell the FDA the whole story because they are worried that their specific product differences may be leaked: affecting $tock price and capital resources. So they fail to do what's ultimately best for approval.
    Did you know that over 50% of fda employees previously worked in pharma? Leaks?

    The dumbest thing in pharma? That pharma companies don't set up specific pre launch drug study protocols with FDA guidance? They follow basic guidelines; not even requesting guidance. If they did, That would guarantee approval.
     
  14. Anonymous

    Anonymous Guest

    Asking about a big dumb blond guy, big on his suits. There was a shlub that came from Axcan to our company. Right away, he began targeting people he wanted to take out, to move himself forward. He has no morals, no ethics and went for the juglar. EVen the new salse manager noticed he took credit for work he didn't do, manipulated old mger into giving him a promo and got there, because the territory he was hired into, was doing gangbusters way before he arrived. Last but not least, he was a liar and lowlife and mean a hell. Anyone know this jerk?