We have no idea right now what MIK001 is for Actavis. Its a big secret you see? Very exciting though. Since you felt Elite's big drawback was they had no large partners, you must be excited about this!!
From Mikah's website
"Mikah Pharma has contracted Elite Pharmaceuticals to develop and manufacture our top leading products."
And we are close to launching those generics for them too!!!!
But really the most exciting piece is still the BE trials and 505(2)(b) product
"Well, I think our strategy, Anthony, is around doing an ANDA or 505(b)(2) that we can control ourselves. And we think -- which is what I was talking about earlier about doing bioequivalent studies and those types of studies -- to get a product on the market with the abuse resistant technology.We think if we think if we can do that type of thing, then the value for the -- a product that would require a full efficacy study will go up, and we'll do it in that kind of timeframe. So strategically we're kind of looking at it as a two-step process. Do these first and then do a bigger strategic alliance on a more costly study."
All this talk about Oxycontin but in reality we are looking at BE trials and 505(B)(2) starting up soon for ANDAs and an NDA.....
CEO
"I mean, if you look at the abuse resistant marketplace and the technologies that have been utilized, you have the biggest, which is Purdue with their OxyContin product, and that's basically a hard shell. It's theoretically harder to crush, but the reality is if you put it in the microwave for 20 more seconds, then you're right back where you started from.
You have pain therapeutics, with the gel and people putting in -- what is it, nicotine and caffeine? We are sort of a one off. I mean, Embeda is a sort of the closest, but the difference there is that it's a one beat system. So you have the opioid and the agonist on the same bead, and that's why they have the manufacturing problems that they have. It's difficult to do all on one bead.
What we've done is just separate them into two different beads. I mean, that's why we are excited about it. It's different. Quite frankly, it's much more straightforward, and it uses the pharmacologic approach, which clearly the FDA likes the best, because it's understandable in terms of the science. Okay?
You don't get high, because the agonist competes with the opioid for the receptors on the brain. Okay?
I basically talked about the kind of things of what we're going to do in this fiscal year; what our goals are from moving towards cash flow positive, ex-biostudy expense, and working on our abuse resistant products, hopefully bringing our final products to market.....
Extending the patent exit estate both here and internationally. Getting into the new facility and having that approved.
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