1. Mylan approval appears very unlikely in the near term
And third, an unknown to us prior to approval. The FDA developed their own analytic tests and evaluated our products and others in the FDA labs. They concluded that our product as we expected showed therapeutic equivalents to Copaxone with no observed differences.
They also established that other products such as Natco's product in India were analytically not equivalent to brand Copaxone. While it wasn’t commented on in the CP, it is possible that all applicants were asked to submit their product for FDA analysis.
2. Craig believes that they can have the sole generic for quite a while:
We don’t know what the results were, but if they tested non equivalent, it could result in a significant delay for competitors as they retrench to develop the needed analytic package to allow them to properly manufacture and approvable generic. Overall, the FDA CP response allowed us to infer that we could possibly have an extended period of sold generic status for this product.
3. Slide 8 shows that MNTA / Sandoz could get about 30,000 patients if they are the sole generic --
25,000 of the people using the daily copaxone using the generic 4,000 of new MS patients 1,000 MS patients switching from non-Copaxone to Copaxone
4. Craig forecasts that generic copaxone could cost about 35,000 based on the following:
Teva’s list price of $73,000 annually for the once per day Copaxone must also be adjusted for compliance rate and tablet discount strategy. Compliance in this category has been estimated about 80%. Using IMF data, it can be estimated that Teva’s average discounts and rebates on this product are probably in the 20% to 25% range, combining these estimates, the value of the Teve once a day patient for Teve is approximately $47,000. Adding a typical sold generic discount of 15% to 25% and using 25% to be conservative, this year the generic patient value of around $35,000.
5. So 35,000 * 30,0000 = $1.05 Billion annual Glatopa revenues is what Craig is suggesting the analysts should be modeling.
6. The generic for three times per week Copaxone could be coming sooner than expected?
We believe our generic three times per week Copaxone could be on the market as early as the first quarter of 2017.
7. Their Biosimilar program (Slide 14) is targeting $30 Billion of branded drug sales. Their first three are generics for Humira, Orencia and Avastin. None of the others have been named.
8. Craig is hoping for a new partnership for their biosimilars in the second half of 2015.
So, our goal right now is to try to get partnerships soon and our preference – I we can find it is to get a broad portfolio partnership so we can actually thrive to capture the portfolio value and the efficiency with the manufacturing or growth portfolio.
Things looking really good. I added more on the drop to $17.5 yesterday after the earnings call.
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