Rule Breakers
analyst Karl Thiel told subscribers recently that he thought Momenta Pharmaceuticals
After handing down a ruling yesterday that Momenta's generic version of sanofi-aventis'
It was a long shot by Sanofi, but the loss of generic Lovenox would have been a huge deal for Momenta, since that's its only product. Shares are up 4% today.
The wall of worry hasn't crumbled completely, though. Momenta's deal with marketing partner Novartis
Trying to figure out what the FDA will do in this situation is nearly impossible. The agency took nearly five years to approve Momenta's drug, because the company had to convince the FDA that it could fully characterize the complex molecule that makes up Lovenox's active ingredient. Without a lot of inside knowledge, it's impossible to know whether Teva or Amphastar have the same capability to satisfy the FDA.
A quick rejection that sends potential competitors back to the drawing board would be the best thing for Momenta's stock. But at this point, time is working in favor of the company as well. The longer Momenta goes without additional generics being approved, the more money the company makes, and the more likely investors are to scale that wall of worry on their own.
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