Biotech Values

[tinkershaw]

No, not at all. Rather, I’m challenging RockRat to explain why he finds it unfathomable that Teva could have behaved in a manner similar to Amphastar and HSP.

The more I look at the language that Teva has perpetually used, the more you look at Teva's business, and the how and why they do things, the more incredible it would be if Teva had actually invested enough time and money to actually develop a generic lovenox utilizing the depth, skill, and technology that MNTA has employed.

Why is this? Because that is just not Teva's business. Teva goes after generic after generic, tens and tens and tens of generics. Their business is to identify chemical sameness of the active ingredients, recreate it, and demonstrate that the remaining "junk" is not dangerous. That is how the generic generic drug is developed. What Teva does, is they do this at high speed so that they can be first to market and enjoy the 6 month exclusivity window. They do this for generic drug after generic drug.

They target enoxaparin, which may be 2-3-4%, at most to their bottom line. So what is their corporate strategy, to develop in-house the stupendous technology that MNTA has, or do they deploy their usual strategy towards developing generic drugs?

Look at the language that Teva has used over the years, in their arguments to the FDA, in their press releases, in their press conferences, they talk about the usual rules of generic drug development.

Look at the corporate interests of Teva, is a generic lovenox product so valuable to Teva that they would heavily invest insider resources to develop the technology that MNTA has developed? The answer is absolutely not. Particularly not back in 2002/2003 time period.

Would Teva have reason to believe that pushing ahead with their boiler plate processes to develop a new generic drug would be insufficient with generic lovenox back in 2003? Maybe, maybe not, but the most likely decision was, why not give it a try. The expense is minimal, just another generic drug to develop. We will create chemical "sameness" by indentifying the active ingredients, and then just make sure the "junk" is not dangerous. That is what we do for all our generic drugs. And givne the history of the drugs in India, it is a great starting place that we can cheaply work with.

From Teva's perspective it makes sense. They are not a purveyor of novel and sophisticated drugs and generics. They grew to what they were by being precisely the opposite. They produce unsophisticated drugs (which copaxone largely is in the scheme of things) and generics, by being the first to market and getting the 6 month exclusivity. That is what they do, that is all they do. Given this, why would Teva waste the time, energy, money, and resources, to develop technology like MNTA developed. This is all MNTA does, for Teva, it is a tiny part of their business. 2, 3, maybe 4% to the bottom line at most.

So why wouldn't Teva stick to their core business in every generic drug that they pursue. It is what they do. Identify the active chemical sequences, and make sure the rest of the junk is not dangerous, and get it to market first with the 6 month exclusivity window.

It really makes the most sense.

Now, since the FDA issued its standards in July for lovenox, it is possible, that after 7.5 years or so of non-approval, that knowing the actual standard, that Teva has re-jigged its drug, in the last 3 months to meet this much stricter standard. That is possible.

But does that even make sense? I don't know. What does makes sense is that Teva would utilize a strategy such as Dew has indicated for its generic submission, as this is just another generic for Teva. Why would Teva commit any more resources to it than this? I mean, really, What corporate purpose would it serve in the scheme of things, particularly thinking back to 2003. Novartis certainly decided not to commit such resources to developing technology like this in-house back in 2005. But for MNTA, it is all they do, IT WAS THE ENTIRE COMPANY, and the purpose of the entire company.

With all this, what Dew is saying makes perfect sense, and in fact makes more sense, than Teva was somehow investing extraordinary resources in lovenox. Which would not make any sense once you understand what Teva's business is. Teva produces generics, Teva talks in terms of generics, and why would Teva not approach lovenox in the same fashion as it does all its other generics?

If this is the case, then how much sense does it make that once learning of the FDA standard for lovenox, that Teva would be able to re-jigger its drug within the last 3 months or so to meet the standard, when for the last 7-8 years they have produced a generic drug that would meet what Teva hoped would be a lower, and more generic, generic standard that Teva has grown to master and dominate? Not a lot.

If Teva can pull it off, more power to them. It will be an extraordinary feat by an extraordinary company. But really, Teva's business is copaxone and generics. They do not develop complex and novel drugs and complex and novel generics. Those are expensive and time consuming and get in the way of Teva's core competencies. What they do is develop a lot of generic drugs quickly and get them to market quickly. What MNTA does is develop a few complex generics, so complex, that they re-write the entire rule book on generic approval.

So it is hardly unfathomable that Teva would have behaved similarly to Amphastar. In fact it not only makes perfect sense, it makes more sense than the alternative that Teva was pursuing generic lovenox with the fervor and skill of MNTA. Which certainly would not have been even close to the case if you think about it.

Tinker
Heck, I don't know. But as a thought experiement, yeah, what Dew says makes eminent sense, and in fact more sense than the alternative.