) --In July 2009,
executives were enthusiastic about the experimental lymphoma drug pixantrone, telling investors to expect the drug's U.S. approval in the fourth quarter of that year followed by approval in Europe in the third quarter of 2010.
Cell Therapeutics said Tuesday it was on track to
with European regulators later this quarter.
So much for that promised third quarter 2010 European approval.
Once again, Cell Therapeutics demonstrates a chronic inability to make good on its own forecasts. Pixantrone's U.S. approval? Nope. European approval? Still not even filed. A
partnership? Nowhere in sight. A break-even quarter in December 2009 followed by a quarterly profit sometime in 2010? Don't hold your breath.
It's not just that Cell Therapeutics whiffs regularly on its own guidance. More egregious is that the company never apologizes or explains. Instead, Cell Therapeutics -- led, of course, by CEO Jim Bianco -- just changes the subject and hopes shareholders forget.
Tuesday's press release is a great example. Cell Therapeutics announced with some level of glee that European regulators had approved the company's plan to study pixantrone in kids diagnosed with lymphoma and solid tumors. Getting regulatory sign-off on this so-called Pediatric Investigation Plan or PIP "clears the way" for the company to submit pixantrone for regulatory approval in Europe, the company said.
Left unsaid by Cell Therapeutics was why crafting a PIP took so darn long or why it mattered in the first place. If you go back through the company's conference call transcripts from all of last year, you'll find no mention of a PIP in discussion of the timelines for pixantrone's European approval. That's because PIPs are a routine part of European regulatory filings -- something done by just about every company seeking to market a drug in Europe.
Cell Therapeutics didn't start mentioning plans for a pixantrone PIP until this past April, right after
It's hardly a coincidence that Bianco started talking up pixantrone's potential benefit for kids with cancer at precisely the same time that U.S. regulators kicked pixantrone to the curb.
Cell Therapeutics doesn't even know if pixantrone will help kids with cancer because the company has never run a pediatric clinical trial. In Tuesday's press release, Cell Therapeutics says pixantrone studies in kids won't likely be conducted until after the drug is approved in Europe.
How likely is European approval? Left unsaid (again) by Cell Therapeutics is that the company is trying to get pixantrone approved in Europe on the exact same data that was rejected by U.S. regulators. That makes the entire pixantrone-PIP issue a meaningless smokescreen when it comes to European regulators decided on whether to approve the drug or not.
The FDA didn't just reject pixantrone, the agency and its outside panel of cancer experts practically laughed the drug right out of Washington D.C. European regulators are different and will be more accepting of the pixantrone data, Cell Therapeutics contends. The company wants investors to believe that pixantrone stands a better chance of approval in Europe.
That, to me, sounds a lot like another empty promise.
--Written by Adam Feuerstein in Boston.
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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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