Biotech Values

[10nisman]

MNTA/TEVA

Teva officials told the Journal that the company met with the FDA in October and complained about possible bias. It said its application, which was filed two years before Momenta's, is stuck in bureaucratic limbo, and that it received delayed notice when the FDA changed the terms for evaluating the drugs.

Amphastar filed the first application to make generic Lovenox in 2003. It says the FDA told it in late 2007 that it met the standards for "sameness" but then the standards changed. The company sued the FDA in October, alleging favoritism.

I think this WSJ article puts everything into context. Teva stated on its latest Teva earnings call said that it was told by the FDA that it achieved "sameness". According to Amphastar it was told in late 2007 that it met the standards for "sameness". So IMHO Teva's was just repeating what the FDA stated to them in 2007 before MNTA changed the standards.

10nis