Biotech Stock Mailbag: Onyx Pharma, Amarin
Onyx wins at the FDA panel by convincing the experts that "refractory/intolerant" is a clinically meaningful and valid definition for unmet medical need in multiple myeloma. It's a challenging, but not impossible, task.
I'm predicting victory for Onyx because I believe panel members won't be dissuaded by a smallish 5% difference in response rate, especially for patients who are critically ill and need new medical options. This is essentially the same argument that Talon Therapeutics used successfully at its FDA panel in March to garner a positive vote for the lymphoma drug Marqibo, despite iffy clinical data.
If the FDA panel votes against carfilzomib, Onyx falls back on an ongoing phase III with interim results expected in the first half of next year. This study compares carfilzomib plus Revlimid and dexamethasone against Revlimid and dexamethasone in multiple myeloma patietns with less advanced disease.
Discussion of carfilzomib is not complete without acknowledging potential competition, in the nearest term from Celgene's pomalidomide, also filed with FDA already for relapsed/refractory multiple myeloma. Watch soon for FDA's response to Celgene's filing to see if the drug is granted a six-month or 10-month review.
Make sure to stop by the live blog on Wednesday.
@josiahmp, carrying on a conversation with someone over Twitter this week, writes, "I agree that it seems like AF
I haven't questioned Amarin's(AMRN) legitimacy. What I have done is acknowledge that not everyone is an uber-Amarin bull and that it's legitimate and important to assess the risks to the future commercial potential of the company's prescription fish-oil pill AMR101.
What doesn't make sense to me -- and is crazy, to be perfectly honest -- is the suggestion that you can't be bullish on a stock and at the same time criticize the stock or raise questions about risks.
I still believe FDA approves AMR101 on July 26, but I can be bullish while still acknowledging that we don't know everything that's going on between FDA and Amarin right now. A drug review is not a transparent process, so what happens if Amarin has an undisclosed manufacturing problem with AMR101, or if a study design flaw has tainted the data we have seen already?