FDA Won’t Take Filing From Pharmacyclics
I don’t remember the FDA issuing a “refuse to file” letter in recent memory but Pharmacyclics got one from the FDA recently for their drug Xcytrin (motexafin gadolinium). It is intended to treat non-small cell lung cancer patients with brain metastases. Here is the FDA definition of “refuse to file”.
Pharmacyclics: FDA Won’t Take Filing - Forbes.com:
The stock dropped 46% on the news and is definitely bad news. The FDA said there was not enough in the filings to bother with a substantial review and that too many clinical trials had failed to show statistically significant differences from between treatment arms. This leads me to wonder who is heading up the regulatory group as this sort of situation should never be allowed to happen.
Looking up refuse to file I found that Imclone received one back on Jan 2002 over Erbitux.
Pharmacyclics had a webcast conference call yesterday and is available for one month. I’ve listened to it and not much new was added. They will be having meetings with the FDA to determine where they will be going next. The company basically thought the meetings with the FDA previously went well and they thought highly of this drug and the data and felt they were encouraged by the FDA to go ahead and make the submission. They also used outside consultants who agreed that they should go ahead with a filing.
They only have about a years worth cash on hand and so it will be interesting to see what happens in the next twelve months.. Only three questions were asked and it was a very short call.
Here is the company’s press release.
Other Resuorces
Xcytrin - Yahoo! Search Results
Xcytrin - Google Search
Google Blog Search: Xcytrin
IceRocket Blog Search: Xcytrin
Technorati Tags: Pharmacyclics, motexafin gadolinium, Xcytrin
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