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Zalicus Inc. Message Board

  • pattonjim95 pattonjim95 Oct 22, 2013 9:52 AM Flag

    the phsae process

    According to the Parkinson Center of Oregon, a major player in conducting Investigational New Drug (IND) phase testing, approximately 70% of submitted drugs pass Ph1. About 30% of submitted drugs successfully complete PH2. 70-90% pass Ph3.
    It looks like the a successful Ph2 completion will set the stage for partnering. I understand the reluctance of a major player to make a huge $ commitment on a 30% chance but a 70% chance? I have to think one of them will be bellying up to the bar immediately after the Ph2b results, if successful. With all the earlier talk about on going partnership discussions its highly probable that the deal is already in place.
    I'm trying to figure out why PCO refers to "pass" for Ph1 & Ph3 but "successfully complete" for Ph3?? Groups like that choose the wording very carefully.
    Jim Long and calm

    Sentiment: Strong Buy

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    • Because we have the time while our $ drift away.

      "About 30% of submitted drugs successfully complete PH2"

      Of the 30% how many had ODS, and what was their success rate?

    • JIm, interesting read below that notes the statistical advantage of drugs that have been granted orphan designation...

      As of February 2011, there were 460 medicines to treat or prevent rare disease under clinical trials in the U.S. alone.13 Developmental drivers such as government incentives, shorter development timelines and high rates of regulatory approval are making orphan drug development as economically viable as non-orphan drug development, even though the patient pool is smaller.14 The time from Phase II to market is often shorter for orphan drugs due to shorter and smaller clinical trials and FDA Fast Track designation. In one analysis, the average time from Phase II to launch was 3.9 years for orphan drugs, compared with 5.4 years for non-orphan drugs.2 Once a compound has been granted orphan designation, the odds for approval are high (82%) compared to traditional drugs (35%).15 Of note, orphan designation for the drug in the orphan indication is maintained regardless of follow-on indications. As a result, one model for development is based on lead development of a compound with a relatively quick-to-market orphan indication, followed by consideration of expansion to other indications.

      • 1 Reply to jimcasey76
      • jimC: Yes the ODD and hopefully ODS would very positive for many reasons. About a year ago I DD'ed ODS and came up with the following items
        ODD eliminates the $736,000 FDA filing fee
        ODS extends US patents by an additional 7 years and European by an additional 10 years
        ODD moves the IND ahead of other non-ODD IND's in the panel process
        ODD needs only to target 1 OD regardless of whether it is being developed for numerous other common ailments in order to receive ODD and ODS
        The number ODD's that are being approved is growing annually
        ODS's are subject to large Federal grants and other incentives
        ODS's are typically very high cost end user products
        It is a bit murky as to whether the actual approval part of the process is accelerated rather than only the getting in line process, I think not. However the approval process appears become quite similar to a Ph4 review and approval process. Ph4 can be approved at anytime by the reviewer if a preponderance of data show that it has a positive effect on a non-ODD ailment
        Jim Long and calm

        Sentiment: Strong Buy

    • they have been standing at the bar for months now they get to pay the tab

    • If they have the positive results we are anticipating, its quite likely they are already looking for a partner before the results are published. Once published, the partnership is announced.

      • 1 Reply to ride_da_beast
      • partnership deal might look if both trials succeed.
        Following two successful phase 2a trials, Zalicus Inc. (ZLCS) has entered into a collaboration with Merck & Co., Inc. to develop and commercialize Z160, its first in class, oral, state dependent, selective N-type calcium channel (Cav 2.2) blocker for the treatment of chronic pain, including lumbosacral radiculopathy (LSR), post-herpetic neuralgia (PHN), and other conditions.

        Zalicus, a clinical-stage biopharmaceutical company, will receive an upfront payment of $150 million and up to an additional $825 million in development and regulatory milestone payments. Profits will be split equally between the two companies on a worldwide basis.

        The agreement includes plans to launch several Phase III trials over the next several years. Zalicus will pay for 40% of development costs, while Merck will pay the remainder.

        "We look forward to sharing with Merck the responsibility and accountability for turning our vision for Z160 into an everyday reality. Z160 orphan drug status for PHN will expedite patient access to this remarkable medicine and help fund our efforts going forward." said Zalicus Chief Executive Mark Corrigan, M.D.

        In the U.S., Zalicus will book sales and take a lead role in the treatment's domestic strategy development, though both companies will share in commercialization activities. Outside the U.S., Merck will book sales and lead commercialization activities.

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