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Insmed Incorporated Message Board

  • clarefrancis85721 clarefrancis85721 Dec 11, 2012 3:52 PM Flag

    iplex ? too expensive to produce?

    by accident, I googled my way into this food fight...

    but

    since I have a background in manufaturing ( major biochem) ,. I know that mfg and the Merck conversion do not compute ... until a better mfg method, iplex is worthless

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    • I like your handle "clare". Insmed management themselves gave this reason....Dr Allen (RIP) .
      iplex is worthless" ....for now Yes

    • by clarefrancis85721.Dec 11, 2012 3:52 PM.
      by accident, I googled my way into this food fight...

      but

      since I have a background in manufaturing ( major biochem) ,. I know that mfg and the Merck conversion do not compute ... until a better mfg method, iplex is worthless

    • at a Press conferenece 5 years ago,Dr Allen was asked why Insmed was dropping iplex.
      Dr Allan called iplex a one drug risk and that iplex was simply "so expensive" to manufacture.( that is different from posts here about how much Insmed charged.
      No one makes it anywhere in the world now for almost 5 years and no one has plans to,The 18 month clock will start in 2018 if someone wants that risk.
      iplex is dead.

    • I am relying on your biochem background. You have to remember that INSM was approved to market Iplex in the US for short stature (small kids). They had an approved FDA label copy and a market entry per vial retail cost listed with a couple of drug distributers. The cost per vial was around $300, which calculated out to more than $30,000 per year for a short stature kid, or $60,000 for the prescribed treatment period. The guy who knew lots of this stuff was Hi_Lee_evolved bacause he used to participate in a separate website and share information from some of his sources.

      When INSM was in full production mode at Boulder they were producing cGMP batches of Iplex for slightly more than $2 million per batch. Their method was very efficient and while TRCA was throwing away every other batch when DNA was performing manufacturing, INSM was on the money. Their cost per batch was $4 million when Ipsen bought TRCA. Each vial produced was 0.6 of frozen rhIGF-1/rhIGF-1BP-3 which contained 36 mg (W/V) of the active ingredient, which in the case of Iplex was both biomolecules. So, if you emperically take $2,000,000 and divide by $300, it comes out to a batch size of 6,666. That is a pretty small number of vials to produce for one batch. But if you back calculate 36 mg per vial by 6,666, you get around 240,000 mg or 240 grams of active ingredient in those 6,666 vials. That is about 1/4 pound of fermentation product for both the rhIGF-1 and rhIGF-1BP-3. I would expect more like 0.5 to 1.0 Kg of each moiety in separate fermentations in say a 10 or 20 liter, continuous flow fermentation chamber operated for 5 days. What would you expect in terms of grams of protein? Anyway, my guess is that Iplex batches were about 10,000 to 15,000 vials per batch. This would make the mark-up to $300 around 200% of manufacturing cost.

      The other important thing to note is that INSM had MTAs all over the place for Iplex. One young PI at Boston University got 20 vials for a mouse study.

      Also you have to consider the vials that will be used for premies and ROP. The pharmacokinetic goal and data speculate a normal serum levely of 20-60 micrograms per unit of blood sampled. According to the data from Dr. Ley, they hit this mark for 48, 72 and up to 7 days in the dose ranging study. The average daily dose to achieve this level of IGF-1/IGF-1BP-3 in the premies was probably around 1 mg per day. Thus a 36 mg vial would last a month for a premie.

      There is now doubt that they can make Iplex/Preiplex in sufficient amounts to treat premies. The question now is when is Premacure going to start manufacturing through a CRO. That will be a milestone event.

      Check my math, but hopefully Hi_Lee will chime in.

      Sentiment: Buy

    • First of all, happy birthday to your ID...and congratulations on your first post with that ID.
      Second, I agree with Historians sentiment.
      Third, tomhudson has already noted your accidentily finding INSM and the nature of your vast expertise.

      With those three points, you no doubt stayed at a Holiday Inn Express, mr. expert.

    • By accident or by design? Please tell us what a better manufacturing process would be based upon your experiences Could you also explain how or why?
      As we would like to glean the fruits of your knowledge.

    • You're full of #$%$......but you have a good day nonetheless.

 
INSM
16.24-0.18(-1.10%)Dec 22 4:00 PMEST

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