As a comparison to give a guide for POHs possible deal:
BioDelivery Sciences International, Incs BEMA buprenorphine is being developed for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period of time in both patients who are opioid naive and opioid experienced.
BDSI's secret sauce is its BioErodible MucoAdhesive "BEMA" drug delivery technology, which is a small, polymer film that is designed to degrade in the body in a non-toxic manner and is placed on the inner lining of the cheek.
$500m market Sept 2011 - Failed initial phase 3 trial - "We witnessed a high placebo response in the opioid naive segment of our patient population, particularly at our starting dose, which accounted for the overall lack of efficacy that was observed in this trial,"
Our previously announced market projections for the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively."
Jan 2012 - Deal done with Endo even though initial phase 3 missed end point. $30m upfront with $150m to come with milestones.
Jan 2014 - $10m upfront triggered when phase 3 trial met end point of opiod naive patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly (p<0.005) improved chronic pain relief compared to placebo. Additional secondary endpoints were supportive of the efficacy of BEMA buprenorphine compared to placebo.
The most commonly reported adverse events in patients treated with buprenorphine compared to placebo were nausea (10% vs. 8%), vomiting (4% vs. 2%) and constipation (4% vs. 2%).
Another $10m upfront if meets end points in the next phase 3 for opiod experienced patients.
BioDelivery Sciences got FDA approval a few days ago for their BEMA buprenorphine/Naloxone combo for opiod dependence managment. high dose buprenorphine, which takes care of the craving and withdrawal effects from an opioid, and an opioid antagonist, naloxone, to deter abuse. $250m peak sales in US.
POHs target market is about $24 billion worldwide.
So can we extrapolate their deal and put a number on a OxyMorPatch deal pre and post phase 2?
http://www.fiercebiotech.com/story/...in-drug-flunks-phiii-placebo-study/2011-09-29
http://www.streetinsider.com/FDA/En...ne Met Primary Efficacy Endpoint/9083165.html
http://www.fiercedrugdelivery.com/s...d-anti-opioid-drug-delivery-method/2011-09-06
http://www.marketwatch.com/story/bi...nce-treatment-of-opioid-dependence-2014-06-09
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