Thursday, March 19, 2009

Schering-Plough Europe Withdraws 2007 EMEA Peginterferon Alpha-2b (Cylatron) Melanoma Approval Submission. . . .


PharmaNews.EU reported yesterday (with a H/T to my erstwhile anonymous commenter(s)!) that Cylatron, or Peginterferon Alpha-2b, is no longer on the list to be approved (for Stage III melanoma) by EU regulatory authorities, due to a determination by Schering-Plough itself that the risk-benefit ratio isn't sufficient, given the study data:

. . . .At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP). In its official letter, the company stated that the withdrawal of the application was based on the CHMP's view that the data provided were not sufficient to allow the Committee to conclude on a positive benefit-risk balance for Cylatron at that time. . . .

What does this mean for its prospects in the US? [Is it approved here? I haven't looked, yet It is listed as a "Vaue-Added" candidate, in FDA review, per the below commenter -- the above makes it less likely to be approved by FDA, in my estimation. -- Thanks, commenter!]

Anyone?

6 comments:

Anonymous said...

It was filed with US regulatory, part of the "Value Added" pipeline.

Unlikely that it will go forward,
as they report, "In its official letter, the company stated that the withdrawal of the application was based on the CHMP's view that the data provided were not sufficient to allow the Committee to conclude on a positive benefit-risk balance for Cylatron at that time."

The pipeline that was talked about as being so wonderful-has been taking some significant hits.

If they lose Goli/Remi to J/J---ouch.

Anonymous said...

well, more bad news for s/p-this time on the Hep C front:

"Vertex Hep C Drug Improves Cure Rate in Study"

http://www.thestreet.com/_yahoo/story/10474626/1/vertex-hep-c-drug-improves-cure-rate-in-study.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

"Researchers had previously presented the PROVE 3 results from patients treated with telaprevir, but Wednesday's research abstract was the first time data was made public on the patients in the study's control arm retreated with standard therapy alone. "


Gotta figure Freddie new this stuff was hitting the fan~when he sat down to sell the ship.

Anonymous said...

The EMEA and FDA actually have an agreement to share information in situations like this and it does occur.

I think this means you also have to look at what other individual drugs would appear to add the most value to SP's late stage pipeline.

It also makes me wonder if certain review delays and the timing of recent complete responses could have been arranged as a means to juice the perceived value for this deal.

This thought has some obvious implications, however you never know.

Salmon

Condor said...

I agree that it cannot be ruled out, Salmon.

Thanks, as always!


Namaste

Anonymous said...

"It also makes me wonder if certain review delays and the timing of recent complete responses could have been arranged as a means to juice the perceived value for this deal."

The flip side of this all could be that Merck actually overpaid. If so, it may kill that lawsuit looking for a better bidder~. Does anyone think J&J might know some of this and that is the reason they are keeping quiet?

Anonymous said...

I agree with you anonymous.

Actually I thought the same thing but decided to let someone else comment on that possibility since it seemed like an obvious extension of the logic.

Salmon