Biotech Values

[DewDiligence]

MNTA—another writer who could use a little more research.

Indeed! There are several errors in the Pharmalot article you posted. Let’s examine a few of them:

[Lovenox is] a $4 billion product for Sanofi-Aventis. That’s one reason it’s important. The second reason is the active ingredient is an extremely complicated molecule…

Actually, Lovenox is not a single molecule—it’s a complex mixture of molecules. If Lovenox were a single heparin-based molecule (such as Arixtra, for instance), I can guarantee that the FDA would not have needed five years to approve NVS/MNTA’s ANDA.

Momenta and Sandoz somehow convinced the FDA that their product is equivalent in safety and efficacy to the original product without the need to fully characterize the structure…

This could not possibly be more wrong. It was MNTA’s proprietary characterization technology (acquired from MIT) that enabled NVS/MNTA to convince the FDA that their generic was chemically equivalent to branded Lovenox.

What the FDA did was ask Sandoz and Momenta to create a robust clinical trial…

Wrong again—the FDA did no such thing.

…it was not as extensive as going through all three phases for a new product approval, but not as lacksadaisical as a small molecule generic.

There is no such word as lacksadaisical.

Pharmalot says Jonathan Pan, the author of the above statements, is a senior associate at the Scientia Advisors consulting firm. Whatever his official title may be, I would suggest that Mr. Pan is a moron.