AMAG Pharmaceuticals:

Not surprising, all these picks are in the model portfolio I manage as part of the newsletter. Follow the link for more information. I took a lot of heat from some of you over my negative comments last week on) and its experimental gout drug Puricase. Many of the emails I received were similar to this one from Grant G.:
"Your piece on reflects a total lack of research. If you simply listened to the conference call from Savient talking about the safety of Puricase, you would know that all these patients had previous cardiac conditions along with a long litany of other problems. None of the cardiac events could be correlated with the treatments...
From all my research, I see no reason why the FDA would not approve this treatment. Results from the treatment are tremendously beneficial to a population that has no other treatment options. For you to imply that the FDA will not approve is simply irresponsible..."I didn't get a chance to listen to Savient's conference call before writing about Puricase. That was a mistake on my part. I did, however, read the transcript of the call this week and I'm not inclined to change my view.
Yes, Savient defended Puricase's safety (a fact I did note in my previous column) but that doesn't entirely mitigate the concerns the FDA will have about this drug's risk-benefit profile. And let's not forget the poor tolerability of the drug, or the fact that Savient hasn't been able to find a marketing partner. All in all, I just don't see how the FDA approves Puricase on the first pass, especially this risk-averse, in-no-hurry-to-do-anything FDA. Even if Puricase is approved, the drug seems destined for use in only the most advanced gout patients -- not a huge market opportunity. Lastly, in my defense, I did say that the steep decline in Savient's stock price last week already took into account all the negativity on Puricase.