Last week, I reposted a piece from Marco that appeared in Seeking Alpha touting IMGN as an undervalued stock that investors should not ignore. Today, we have another post on this subject from ProHost Biotech in Seeking Alpha.
Normally, I wouldn't care one way or another in speaking to a particular company's valuation, however in this case I think both writers are correct in their assessments. Immunogen is bascially taking a beating due to the fact that Genentech's T-DM1 product did not receive accelerated approval from the FDA. The FDA did not say anything that would call into doubt T-DM1's ability to ultimately be approved for the treatment of recurrent Her2 breast cancer. In fact, the clinical data to date has been very good.
I reposted a nice piece from the Pharma Strategy Blog that explained likely thinking of FDA in making its decision not to grant accelerated approval. The agency was being conservative and likely there was not a clear agreement in place as to the data that would be needed to achieve accelerated approval - particularly with regard to what constituted "all available drugs approved for metastatic breast cancer, regardless of Her2 status".
Bottom line: T-DM1 did shrink tumors in 1/3 of women with advanced Her2-positive breast cancer who had received on average seven prior medications, including two Her2-targeted medicines. The phase III trial continues. It still looks like a winner. Immunogen's fundamentals therefore have not changed and investors should keep the big picture in mind. Immunogen, by the way, does have additional agreements for its ADC technology, including more with Roche.
Posted by Bruce Lehr September 13, 2010.