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YM BioSciences, Inc. Ordinary S Message Board

  • skidbomb1 skidbomb1 Dec 15, 2005 6:08 PM Flag

    Tesmilifene

    I know this might sound crazy, however, I have heard that the side effects of Tesmilifene can be pretty harsh...patients experiencing "blackouts and strong odors" after the drug is administered. While this might not be a big deal if the drug can dramtically extend your life, I just wanted to know if anyone has any dirt on these side effects.

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    • >Do you happen to know if YMI owns in Aero-LEF a particular Device, or is it instead an aeroslized drug, that could be adaptable to the best Device?<

      I talked to IR about this issue a while ago. The YM IP is not tied up in the device, and they probably could switch if needed, but it is using a particular device at this time, and, if for some reason they couldn't use that device, there probably would be some not insignificant difficulty/delay.

      However, while it might be nice to have access to the Phillip-Morris device, if the results of YM's future trials are at all consistent with their first trial, I don't think the effectiveness of the current device will ever be an issue.

    • John/all: the figures quoted represent the expected market share for Delex; not the total market available.

      Impressive figures, if attained, from YMI's 3RD PRODUCT IN THE FOOD CHAIN.

    • rfj - and Randy too

      Thnkx for your research, I appreciate your sharing. The only way I seem to help is by looking for any chinks in the armor, and asking troubling questions.

    • Hi io_io,

      First, I do intend to answer your e-mail!

      Second, if you look at the corporate presentation, you'll see that AeroLef is adaptable to a wide range of devices...

      Someone should go to the presentation and make a list of everything YMI owes us through the first half of the year....no time right now for me.

      J

    • "My understanding is that NDAs will be filed for the first indication in 2007 and for all of the remaining indications in 2008. "

      Looks like rfj you have been researching. But wow that's a lot of NDAs to look forward to.

      Question about Aero-LF: did you see the piece where DSCO has just partnered with of all people Philip-Morris for this new aerosol device. There is a very good WSJ article a month ago about the device - it's not targeted at Fentanyl by any means, but as a more general means of getting drugs to the lung surfaces. The WSJ said it was 90% effective at transporting aerosolized drugs, compared to at most 40% for previous technologies.

      Do you happen to know if YMI owns in Aero-LEF a particular Device, or is it instead an aeroslized drug, that could be adaptable to the best Device ? The P-M device seemed to be so revolutionary it sounds as if we might be better using it (or someone else will !).

    • Reid,

      I was actually agreeing with you. I don't remember what the BTM report says (I don't have it with me) but if they do say several or dozens to get any approval, they're just plain wrong.

      My best guess? Two phase IIIs for the first indication, and one trial each for the remaining four label expansions. However, once AeroLef receives approval for the first indication, one would expect that it would begin to penetrate all of the later indications on an off-label basis.

      However, the range of scenarios would be between 5 trials to get all five indications (best case) to 10 trials if two trials each are required for each indication (worst case). I'm guessing 6 trials to gain all 5 indications.

      Of course, once they get approval for the first indication, they're makin' money. Should be in mid- to late- 2007. However, I doubt YMI will be an independent entity that long.

    • >On AeroLeF, I have no clue what BTM is thinking. They refer to "many" and "dozens" of phase III pivotal trials.<

      >>Looking back historically over pain clinical trials YMI will likely have to do two phase III trials per indication. There are 5 major indications they are likely to pursue:<<

      John -- not to split hairs, but . . . I'm going to split hairs.

      The BTM report talks of the several or dozens of trials necessary to get any approval, not approval for all five indications. To me, their report is either garbled on this point or they meant what they said. To me it looks like the latter, and, in any event, they are wrong.

      As to the necessity for two phase III's per indication, do you really think the FDA will require that assuming the company has already received approval for one or two very similar indications? For example, safety would have been demonstrated in the prior large trials leading to approval.

      Reid

    • Don't look at my math too closely in the previous post about AeroLef--should say minimum of 5 maximum of 10 trials to gain approvals for all five indications.

    • Reid,

      >On AeroLeF, I have no clue what BTM is thinking. They refer to "many" and "dozens" of phase III pivotal trials.<

      Looking back historically over pain clinical trials YMI will likely have to do two phase III trials per indication. There are 5 major indications they are likely to pursue:

      1) Acute pain ($500M market)
      2) Cancer pain ($120M market)
      3) Breakthrough cancer pain ($750M market)
      4) Chronic cancer pain ($300M market)
      5) Chronic pain ($600M market)

      Total of at least 5 large phase III trials (two for first indication and one each for label expansions). These trials are easy to enroll, quick and relatively easy to conduct. I believe they will enroll 600 patients at a 1:2 ratio for the first phase 3.

      My understanding is that NDAs will be filed for the first indication in 2007 and for all of the remaining indications in 2008.

    • ...I think perhaps the only reason we're not there already is because we're a Canadian bio with a fairly hard to understand corporate and profit structure with many irons in the fire all over the world including a unique relationship with Cuba. As rji stated he spend over 200hrs in his DD...You've probably spent perhaps the same amount of time...I know I have tried to do as much DD as possible but I don't have the scientific expertise to really comprehend perhaps all that I should. That's why a board like this one has been so helpful.

      From a business standpoint the royalty payment incentive is truely exceptional. It goes directly to the bottom line. Pure 100% profit with no real substantial overhead or production/distribution risk. A great business model provided you keep developing new products to replace those expired or which are non competitive for whatever reason or have gone generic.

      Once we get our first drug approved and the royalties coming in the street will suddenly wake up and smell the coffee. That is of course as you suggest we're still around at that time for the recognition...

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