Threshold says survival data from its phase II study were impacted negatively by patients who crossed over from the control arm to receive TH-302. Point taken, but still, TH-302 will need to improve its performance in the ongoing phase III study in order to produce results competitive to Abraxane.
I'll also warn again that data generated by phase II trials are generally stronger than what emerges from larger phase III trials. Case in point, Celgene reported median overall survival of 12.2 months from the phase I/II single-arm study of Abraxane plus gemcitabine. Obviously, this result weakened in the phase III study. I wouldn't be surprised to the same happen to Threshold's TH-302.
announced the commercial launch of Vascepa on Thursday, which prompted @JackBrada to tweet, "There goes #5 on your 13 for '13."
He refers to my list of
13 biotech stock predictions for 2013
, of which No. 5 states, "Amarin delays the commercial launch of its triglyceride-lowering fish-oil pill to the second quarter due to manufacturing and supply issues. Vascepa sales fail to meet lowered expectations."
I was wrong on part one of my Amarin prediction but I still have a shot a partial credit if the Vascepa launch is slow. Nothing I've heard from Amarin management yet about launch expectations makes me fear being wrong about the second half of Prediction No. 5.
I'll report on Vascepa prescription and sales data if/when they become available from IMS Health and Wolters Kluwer. Amarin management may comment on the Vascepa launch when the company reports fourth quarter and year-end at the end of February.
@GerardNocia asks: "Any thoughts on
(AEZS - Get Report)
and the upcoming mm [multiple myeloma] data?"
Yes, perifosine failed in colon cancer -- the drug's best shot at success. Keryx abandoned the drug, returning rights to Aeterna Zentaris. For some reason, Aeterna decided to continue on with the multiple myeloma trial, even though patient enrollment was already painfully slow (suggesting little interest from doctors or patients).
My thoughts? Perifosine will fail in multiple myeloma just like it did in colon cancer. This isn't exactly a non-consensus prediction, judging by Aeterna's stock price as we head into the expected interim results due this quarter.
-- Reported by Adam Feuerstein in Boston.