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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

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October 18, 2013

Ariad (And Its Drug) In Trouble

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Posted by Derek

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?

Comments (8) + TrackBacks (0) | Category: Cancer | Regulatory Affairs | Toxicology


COMMENTS

1. Boo on October 18, 2013 12:50 PM writes...

Damn. I know some of the researchers at Ariad. Good people. Ariad has been one of the few small companies to maintain, or even expand, research while commercializing a potentially important drug. I'm sad for them, and for the patients whom this drug was hoped to help.

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2. Boo on October 18, 2013 12:56 PM writes...

Maybe Ariad will be able to rescue this, but it feels a little like my time at Bayer, when the withdrawal of Baycol dashed the company's ambitions for rapid growth (and construction projects) into crisis mode retrenchment almost overnight. This industry is not for the faint of heart.

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3. lynn on October 18, 2013 1:01 PM writes...

Very sad. I thought the science behind ponatinib was excellent. I haven't been able to find out [not that I've spent too much time on it] whether the clotting and reported cardiac effects have any sign of being mechanism [kinase] based - or are they off-target. Anyone know?

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4. Guppy on October 18, 2013 1:15 PM writes...

Coagulation disorders are a common enough problem in cancer patients to begin with (including possibly CML, which I think can result in both hypo- and hyper- coagulable states). It is entirely possible that this problem is not an off-target side effect, but inherent to the drug's action.

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5. Chrispy on October 18, 2013 2:01 PM writes...

I still hold a grudge against Ariad for trying to defend over-reaching patents on NfKB. That was a stumbling block none of us needed.

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6. hn on October 18, 2013 9:04 PM writes...

I believe ponatinib is the only good option for drug resistant patients with the T315I mutation, short of bone marrow transplant. I hope they are able to work out how to control the adverse effects.

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7. ajay malik on October 19, 2013 3:07 AM writes...

I agree with "hn" that it is a great option for patients with T315I BCR-ABL mutant form. The drug will survive at least for this subgroup.

Permalink to Comment

8. petros on October 21, 2013 9:54 AM writes...

re 3

The number of kinases hit by ponatinib is such that it would be impossible to be sure where the problem lies.

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