« Cognitive Dissonance at Lilly |
| Diazomethane Without Tears. Or Explosions. »
October 18, 2013
Ariad (And Its Drug) In Trouble
Ariad's Inclusig (ponatimib) is in even more trouble than it looked like, and that was already a lot. The company announced earlier this morning that its Phase III trial comparing the drug to Gleevec (imatinib) is not just on hold - it's been stopped, and patients are being taken off the drug. That can't be good news for the drug's current approved status, either:
Iclusig is commercially available in the U.S. and EU for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia. ARIAD continues to work with health authorities to make appropriate changes to the Iclusig product labeling to reflect the recently announced safety findings from the pivotal PACE trial that was the basis of its marketing approvals.
If the approval trial has now shown such unfavorable safety, is approval still warranted at all? That's what investors are wondering, and I would imagine that the oncologists who would be prescribing Inclusig are wondering the same thing. This is bad news for everyone. There are patients who very much need a drug like this for resistant CML, and Ariad (needless to say) needs to be selling it. I believe that the company is putting up a new building, not far from where I work, and you have to wonder if there are some clauses in the contract that are going to need to be invoked. Do sudden adverse events with your main commercial product count as force majeure?
+ TrackBacks (0) | Category: Cancer | Regulatory Affairs | Toxicology
POST A COMMENT
- RELATED ENTRIES
- XKCD on Protein Folding
- The 2014 Chemistry Nobel: Beating the Diffraction Limit
- German Pharma, Or What's Left of It
- Sunesis Fails with Vosaroxin
- A New Way to Estimate a Compound's Chances?
- Meinwald Honored
- Molecular Biology Turns Into Chemistry
- Speaking at Northeastern