We know who Epic and Mikah are, but who is Elite Pharmaceuticals? Elite is a little company that's been around a long time. And their specialty and focus? Extended release and abuse resistant opioids. And they have already passed an Oxycontin product (a once a day Oxycontin) through both Phase 1 and Phase 2 trials and seem to looking for a partner to go into Ph3 based on conference call transcripts. Also seems they are looking more at abuse resistant generic opioid products that they will manufacture for themselves. The company's website identities these products as in "scaleup". The CEO noted on a recent PR they were about ready to enter studies for at least one product. Also just so happens that the Chief Scientific Officer at Elite Pharmaceuticals developing these formulations is none other than the President of Epic.
Elite has 8 approved FDA drugs but two of them are what ties this together. Hydromorphone, an often abused opioid known as Dilaudid and Naltrexone the key antagonist noted above in Embeda. And where did these two products and ANDA applications come from? Turns out that they came from Mikah Pharmaceuticals originally from Actavis Totowa in trade for some cash and R&D work. And as part of the Naltrexone agreement, Elite and Mikah signed a deal to develop a 505B2 NDA identified as MIK001. Elite would also contract manufacture this product for Mikah. The 505B2 pathway is the likely requirement for drug submission and approval by the FDA for abuse resistant opioid formulations of current opioid products. And what is Elite's technology and IP based on? The antagonist (Naltrexone) and agonist (opioid) approach. They received two patents in the past year for this technology and formulation capability and have others pending.
While the Embeda concept described above is to put both the Naltrexone and Opioid on the same bead, Elite uses their patented formulation to sequester the Naltrexone using multiple beads, identical looking and indistinguishable except one carries the opioid and one carries the antagonist. The company has put over 100 million dollars into their R&D over the years and you have probably never heard of them.
So where might Actavis get its IP and technology? It would seem that they already have at least one partner in this business, with patent protection using the agonist/antagonist approach similar to Embeda. Remember this article, I am betting that you hear more about these relationships in the future. Actavis, Epic, Mikah, Elite...
--------------------------------------------------------------------------------
FROM LASER
