This morning I was browsing through my lifestream, in particular checking out the Pharma and Biotechnology news on Twitter to find out what's significant today, when a tweet from Scrip News made me sit up and pay attention:
Credit for the scoop though, should go to CNBC's Mike Huckman, who broke the news last night:
Whoa, FDA has cancelled the GI meeting to review GSK's Rezonic data? Wow. Rezonic, also known as casopitant, is being developed as an NK-1 inhibitor for post-operative nausea and vomiting (PONV) and chemotherapy induced nausea and vomiting (CINV). It would be the second to market in this class of drugs after Merck's Emend (aprepitant), who I should disclose, are one of my Pharma clients.
A cancelled FDA meeting usually means significant delays owing to the need for more supporting data. I checked out the global GSK website, nothing. Checked out the US website and bingo:
"GlaxoSmithKline (NYSE: GSK) confirmed today that the May 20 FDA
Gastrointestinal Advisory Committee meeting for REZONIC® (casopitant)
has been cancelled.
GSK is performing additional analysis and is engaging with the FDA to determine appropriate next steps.
application filed for REZONIC seeks approval for the prevention of
chemotherapy-induced nausea and vomiting (CINV) and post-operative
nausea and vomiting (PONV)."
All in all, this is good news for Merck and bad news for GSK: delays in time to market can have a significant impact for both brands. The timing is also awkward – at the end of the month it's the annual ASCO meeting, so handling negative PR in the form of delays will be all the more acute and embarrassing. I'm not sure what 'additional analysis' means exactly but that doesn't inspire me with confidence. Either a drug works effectively or it doesn't. We'll have to wiat for more information and see what the next steps are.