Some thoughts on Puma’s neratinib. The Advisory Panel voted 12 to 4 in favor of approval as adjuvant therapy to prevent breast cancer from recurring after women are in remission for women whose tumors test positive for HER2. Going into the meeting, there was a question mark on whether the Advisory panel would give its blessing due to the fact that the drug has side effects: 95% of patients had diarrhea, of which 40% was serious for a drug that would reduce reoccurrence in ~1% more patients than SoC. It will get approval since you could always use another tool in the shed, but it will be interesting to see if the FDA will approve it for the broad label that Puma requests or a narrower one that some advisory meeting panelists wanted. My guess is the label will be narrowed to where the benefit was almost double in patients whose tumors tested positive for both HER2 and the estrogen receptor (called ER+). If I was a pt, taking it for HER2/ER+ is almost a no brainer but otherwise I’m not so sure. Currently, Puma’s valuation is based on all patients taking neratinib for all HER2 BC pts in an adjuvant setting. I’m sure if nothing changes and the FDA accepts the neratinib label as is, I wouldn’t be surprised if it didn’t meet the expectation of all pts taking it due to the adverse effect profile.
I don’t know enough about what trials Puma is running in metastatic breast cancer similar to SPPIs poziotinib but that is down the road as far as focus. Right now SPPI is focused on poziotinib’s potential in NSCLC patients with EGFR Exon 20 Insertions for which we will have data read out later this year.
And of course, being that we will get a real strong hint of poziotinib’s effectiveness in NSCLC before year end, I can’t help but muse on the stock price potential for SPPI if results are positive or consistent with what we heard regarding the compassionate use patient so far. Currently, Puma’s market value is 2.88B which is nearly 6x SPPI’s market cap (or S/P equivalent to $39). Sure this doesn’t take into account the # of pts eligible to take each drug, nor the over 100M in income that Spectrum takes in each year nor of the potential of Rolontis that will start being in the news soon but it’s fun to muse about it.
