Z160 stand alone & in combination (follow up for Jim)
Review the findings that Leconotide with the same target as Z160 has been demonstrated in pain models to be synergistic with morphine (Pain Med. 2011 Jun ;12 (6):923-41 21539704). "Leconotide caused a significant increase in reversal by morphine of the bone cancer-induced hyperalgesia without increasing the side effect profile of either drug." "the potentiating synergistic effect with morphine on hyperalgesia without increased side effects will lead to greater analgesia with improved quality of life."
Also Leconotide was shown to be efficacious alone, but more so when it was given in combination with a potassium channel opener (flupirtine).
Ongoing clinical trials with Prialt are using a pain scale called Visual Analogue Scale Pain Intensity, VASPI, 0-100 mm (VASPI: 100 mm=worst possible pain, 0 mm=no pain) whereas both Z160 trials are using average of daily pain scores (PI-NRS). Why the difference? The difference is indications. They are testing Prialt for major severe pain associated with trauma, surgery, and cancer whereas Z160 is being evaluated specifically for lumbosacral radiculopathy and postherpetic neuralgia.
I think Z160 is going to be "indication specific". Zalicus has picked indications which suggest just that. Lumbosacral radiculopathy and postherpetic neuralgia. Can Z160 control pains associated with trauma, surgery, and cancer? In some cases maybe so, in other cases, we may be looking at a combination with morphine or flupirtine.
It is my opinion that Z160 will work great for specific indications and work great in combination for traditional opioid breakthrough pain which is generally more severe.
Either way, I think Z160 is going to be a valuable and very viable medicine with a high likelihood of meeting its endpoints in one or both phase 2 trials underway based on the performance of leconotide and the specificity and high bioavailability of Z160. STRONG BUY
sci: There is NO WAY that ZLCS would be so dumb as to take it this far and then change the whole enchilada by adding an opioid. That would negate the entire process of takeing this to panel and force them to start over. And they don't have the resources to do that. Additionally the driving force behind Z-160 and Z-944 as well as Z-212 is that they are not opioids.
Get back to reality this argument borders on ridiculous.
Jim Long and calm
Jim, my detailed reply got nixed by Yahoo! I must have said too much.
In summary: Per Corrigan's slides, if Z160 can totally displace opioids, we have a drug (Z160) worth $30 billion in annual global sales on our hands. This would be a fairly big deal. This value exceeds the sales of the top grossing pharmaceuticals on the planet (Humira...double check this) three times (3X) over.
In my opinion, Z160 is more likely to be 'indication specific'. For some indications it will work by itself, for other indications, use in combination will be required. Remember, we are talking about average % pain reduction with success starting at around 30%. I conservatively estimate annual sales of Z160 at $3 billion, or 30% of the top selling pharmaceutical on the planet if it can solidly reduce pain by 30% for the specified indication(s).
Not too bad, but not the whole enchilada either. However, if we capture the $30 billion dollar annual market, I won't complain. This would of course mean that Z160 can achieve its endpoints for both indications with 70% (pick your favorite % reduction) pain reduction and repeat the performance in phase 3 without side effects or getting scooped by a sodium channel blocker or alternative calcium channel blocker. GLTA. Long live Big Red.