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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

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January 30, 2012

(Un)stoppable Pixantrone

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Posted by Derek

This one mixes two categories on the blog: "Regulatory Affairs" with "How Not to Do It". A small company called Cell Therapeutics (catchy name) has been developing pixantrone for last-ditch non-Hodgkin's lymphoma. You'll note from that Wikipedia article that this compound has been knocking around for a long time, and it's had a very hard road towards any sort of approval.

In 2010, an FDA advisory committee voted it down 12-0, and from the sound of things, it wasn't even that close. But the company appealed and resubmitted, since hope springs eternal and all. They were heading towards an FDA decision next week, and the company's CEO was apparently been going around to investors telling them how confident he was of approval. You see, one of the drug's major critics at the FDA, he claimed, had been disciplined for his totally unfair review of the drug back in 2010. So how could they lose?

Like this. The company has announced that they're withdrawing their application, citing communication difficulties with the FDA. I'm sure they have some. The agency keeps trying to tell the company that the drug isn't approvable, and the company keeps on not hearing it.

Comments (18) + TrackBacks (0) | Category: Cancer | Regulatory Affairs


COMMENTS

1. RB Woodweird on January 30, 2012 2:03 PM writes...

"This most recent pixantrone setback is yet one more example of how Cell Therapeutics' CEO Jim Bianco fails habitually to deliver on his promises, hurting shareholders in the process. Eight years after acquiring pixantrone and promising a speedy approval, Cell Therapeutics still hasn't delivered. The same can be said for the company's other long-delayed cancer drug, Opaxio (born Xyotax).

Since late November, Bianco has been awarded with nearly $800,000 in cash bonuses by Cell Therapeutics' board, including a $150,000 bonus for 20 years service to the company."

Isn't the board of a corporation supposed to watch out for the shareholders?

Permalink to Comment

2. SCM on January 30, 2012 2:05 PM writes...

thank you for sharing!

Permalink to Comment

3. processchemist on January 30, 2012 2:09 PM writes...

If FDA says "trial with X patients" , to submit the NDA with X/2, X/4 or 2/3 X patients is not a good idea... the nth story of an awful management, able to play with shares and investor, and leaving cannon fodder on the street (the scientists of the ex Boheringer Mannheim/Novuspharma/CT research centre near Milan).

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4. Matt W. on January 30, 2012 2:20 PM writes...

Interesting how there is one user who wrote all the positive stuff about Pixantrone in Wikipedia and also started the article on "Cell Therapeutics" (which was then deleted).

http://en.wikipedia.org/w/index.php?title=Special:Contributions&dir=prev&offset=20090517053743&target=OfClinicalInterest

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5. johnnyboy on January 30, 2012 2:40 PM writes...

Cell Therapeutics (and its CEO-cum con artist Jim Bianco) is a favorite punching bag of Feuerstein's, and deservedly so. His articles on Bianco's tactics are always an entertaining read. That people are apparently still willing to buy the company's stock is unfathomable.

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6. Ginsberg on January 30, 2012 3:04 PM writes...

Here in Seattle James Bianco is legendary. We have many dishonest arrogant biotech executives but none can hold a candle to JB. If you have money in CTI today you have not done your due diligence.

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7. Sili on January 30, 2012 3:08 PM writes...

Since late November, Bianco has been awarded with nearly $800,000 in cash bonuses by Cell Therapeutics' board, including a $150,000 bonus for 20 years service to the company."

Isn't the board of a corporation supposed to watch out for the shareholders?

Well ... those are rather measly bonuses. Permalink to Comment

8. David Young on January 30, 2012 3:21 PM writes...

As an oncologist, it is a shame that Pixantrone has not made more progress.... unless the drug is not as good as it "seems" to be. We could always use another anthacyline-like drug to combine with Cyclophosphamide, Vincristine and Rituximab for lymphoma patients who have cardiac risk factors, where we cannot use Doxorubicin or have some fear in using Doxorubicin. That is, of course, if the new anthracyline-like drug had less cardiotoxicity and worked as well or about as well as Doxorubicin. Pixantrone might fit that description. But, of course, it has not been studied to fit that need and unfortunately neither a pharmaceutical company or the FDA would study / approve a new drug for that indication.

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9. DrSnowboard on January 30, 2012 3:29 PM writes...

Stuff the shareholders, what about the patients involved in these trials on lame duck compounds that just won't die?

Permalink to Comment

10. bigredbruce on January 30, 2012 3:42 PM writes...

"Looks like what we got here is a failure to communicate" - Captain, Road Prison 36

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11. bbooooooya on January 30, 2012 5:15 PM writes...

CTIC is an egregious example of the worst in biotech management. Bianco's compensation since 2003 has been over $20 million. I don't think bank robbers expect to do that well.

CTIC even went so far as to lobby congress to get their drug approved: http://disclosures.house.gov/ld/pdfform.aspx?id=300445543.

Truly disgraceful.

Permalink to Comment

12. Jobcut express on January 30, 2012 6:18 PM writes...

Learned today that AstraZeneca will soon lose 3000 jobs, see link below. Does anybody have more on this???

http://pharmagossip.blogspot.com/2012/01/axe-hovers-over-astrazeneca-jobs.html

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13. sgcox on January 30, 2012 7:08 PM writes...

Is not it curiosly odd that ~10 years since the dawn of "genome/smart medicine" the anthracyclines still make the headlines ??

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14. bbooooooya on January 30, 2012 9:45 PM writes...

"Learned today that AstraZeneca will soon lose 3000 jobs"

Well, look on the positive side, AZN will also double its share buyback program with them money it saves.

Keep firing workers and buying back stock, that should be a sustainable way to keep the share price up!

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15. Ed on January 31, 2012 3:18 AM writes...

And the Lord said unto thee, increasing the buy backs will increase the debt/equity ratio, which will smite thine WACC lower.

Lo! more projects will get the Almighty go-ahead as they will now have positive NPV. Or reduced pay-off time, depending on thine prefered Holy capital budgeting metric.

And they cried unto the Lord Hark! Who are these prophets and the strange tongues in which they speak.

And Lo! More projects did the get Almighty Nod, albeit in the un-Holy lands of the Far East.

Amen.

Permalink to Comment

16. David Young on January 31, 2012 3:40 PM writes...

I don't see any problem, in principle, with drug discovery looking at more anthracyclines after 40 years beyond doxorubicin. There is certainly a possibility that a newly discovered analogue could be somewhat more potent, or safer, or both. In fact, it may be curious that one has not been found. It may be safe to say that if better, it might only be a little better and then perhaps not worthwhile developing.

The lead article in the January 1990 issue of Journal of clinical oncology was about an analogue of Mitoxantrone that was suppose to be as effective as Doxorubicin but less cardiotoxicity.... but the drug never made it, because, if I recall, the metabolism was not predictable from person to person.

Look, there is a definite unmet need for those occasional patients who have a curable lymphoma, but who cannot get curative chemotherapy because their cardiac ejection fraction is too low for them to receive proper doses of Doxorubicin. A potent analogue that lacks cardiac toxicity would be a welcome addition. Pixantrone could possibly be that drug... but we probably will never know, because the drug is unlikely to be approved. Sadly, the drug has not been developed for that unmet need, but for the supposed unmet need of a second line therapy in low grade lymphoma. (For which there are many drugs and drug combinations available already or soon to be available.) Pixantrone is being developed for the wrong need, the wrong reason, but it is being developed for a setting in which patients are easy to find and for which, if approved, the drug could make a lot of sales. There are too few patients for a trial where the drug is really needed.

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17. LJStewarttweet on January 31, 2012 9:14 PM writes...

That snow storm we had in Seattle 2 weeks ago must be the cause of the delay.

Permalink to Comment

18. Paul J. Soychak on January 6, 2013 4:51 PM writes...

I worked in the lab PIXANTRONE was discovered in. It passed FDA tests and is now Novartis' property. But it's available! Here at UVM where A.P. Krapcho discovered it. Why can't you get it elsewhere. It is all it's hyped to be. Cured my mom's Breast Cancer!

Permalink to Comment

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