Drug Data Dump: Pfizer, Biogen, AbbVie

Three big-cap drug companies dropped news today, likely to give investors time to digest it before next week's big J.P. Morgan investor meeting in San Francisco. Quick thoughts on each.

1. Biogen Idec announced mixed results of its most important experimental drug, anti-LINGO, in acute optic neuritis, or nerve damage in the eye. The hope is that this drug could regrow nerves in multiple sclerosis patients, becoming the first treatment to reverse that disease. Do nerve growth results in the eye translate into nerve growth results in the brain? Maybe. Biogen said there was a 34% improvement in how well patients' eye nerves conducted signals for patients who completed the study that just barely missed statistical significance, but when dropouts were included the results were not significant. There were no effects on secondary endpoints. Shares in the company are down 2% to $345.

Joseph Schwarz, an analyst at Leerink, said the results "could be considered equivocal by many." He writes in a note to investors:

We believe that these results are largely in line with Street expectations, since we believe that the Street is excited for the agent's potential but overall cautious because there is not evidence that the drug can get into the brain in sufficient amounts. We had expected that the data from this largely exploratory study could be confusing and provide fodder for bulls and bears alike. Our model and valuation assumes a 33% probability of success for BIIB033.

2. Pfizer said that the Food and Drug Administration informed it there will be no advisory committee for its breast cancer drug, palbociclib, and said it is in label discussions with the agency. Last year, one researcher called the results "as impressive as I've ever seen," but many on Wall Street are skeptical that the drug will be approved. The FDA has a deadline for a decision of April 13. Shares are up 2% to $32.50.

Chris Schott at J.P. Morgan calls the results "an incremental positive." He writes in a note to investors:

Today’s news clears up some FDA uncertainty. Recall that there has been controversy over whether Pfizer would be able to receive approval on Ibrance based on the phase II data. This uncertainty mainly stemmed from the trial’s immature overall survival data, which has thus far shown a less definitive signal relative to the very strong improvement in PFS seen with the product. We would note, however, that all current ER+ breast cancer products have been approved based on PFS. While the FDA’s approval decision has yet to be made, we see the lack of an FDA panel as an incremental positive for the drug.

3. AbbVie released positive data for tis drug elagolix, for endometriosis. Shares are up 1.6% to $68.  Mark Schoenebaum, the pharmaceuticals analyst at ISI/Evercore, writes:

Detailed data expected at "future medical conference." The magnitude of the benefit and the difference in efficacy between the two doses was not provided. Therefore, we still don't know the degree of clinical benefit (or over time) but perhaps more important than efficacy (which we believe was reasonably achievable based on phase 2 data and mechanism of action) is the effect on bone. We believe the up-side commercial opportunity for elagolix is dependent on the bone impact - both for adoption and duration of therapy. What we learned today is only that declines in bone mineral density were dose dependent. Patients in the phase 3 trial will continue in either post-treatment follow-up or blinded 6-mo extension study. And any evaluation of bone impact would benefit from the longer term patient follow-up.