Feuerstein's Biotech-Stock Mailbag

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Dave D. writes to opine on ImClone SystemsIMCL and its Erbitux, a company and drug I featured in last week's Mailbag:

"Hi, Adam -- good article on ImClone, but you missed a few things:

1. Tolerability of Erbitux is not superior to Avastin; most oncology offices keep a crash cart ready when giving Erbitux due to the possibility of life-threatening reactions during the infusion;

2. Avastin data in brain metastasis from non-small cell lung cancer has not yet been presented and could be positive;

3. In colon cancer, EGFR inhibitors [like Erbitux] are ineffective when kRAS mutations are present, so there may be a group of non-small cell lung cancer patients (possibly 40%) who would not benefit at all from Erbitux therapy.

Just a few thoughts and thanks again for your insight."

I'll address Dave's points in order:

1. Yes, Erbitux patients do run the risk of anaphylaxis (serious allergic reactions), but the incidence rate is very low, about 3%, and there is research suggesting that patients at risk can be identified and pre-treated. You used to hear a lot of worry from doctors about the anaphylaxis risk associated with Erbitux when the drug launched; I don't hear it much anymore.

2. I'm not up to speed on the Avastin-brain mets data, but yes, if it's positive, this could put that subgroup of lung cancer patients more in play between Genentech'sDNA Avastin and Erbitux (depending on the data, of course.)

3. The whole kRAS mutation situation is highly fluid. When I talk to ImClone bears, or those who are ambivalent on the stock, uncertainty over kRAS and what impact it may have on Erbitux market share in colon and lung cancer is brought up often.

ImClone bulls, on the other hand, make the point that a biomarker allowing doctors to identify patients that will respond particularly well to Erbitux has the potential to boost sales. So, Dave, your point is well taken, but at this point, I don't know how it shakes out.

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Mike is ticked about the FDA's delay in making an approval decision on Cardiome's CRME heart arrhythmia drug Kynapid.

"This is getting absolutely ridiculous! Approaching 120 days post-PDUFA and not a single comment from the FDA, Cardiome or Astellas? This could be the biggest investment debacle I have ever been involved in. Does anyone have accountability anymore?"

Mike, I share your frustration. And calling Astellas or Cardiome these days to ask about the situation gets you nowhere. I'm at a loss to explain any of it.

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Lastly, William H. goes where few investors these days dare to tread:

"What is your take on La Jolla Pharmaceuticals LJPC. They have a drug for lupus and have announced great results from an interim analysis of a phase III that won't end until 2010."

Bill, lupus is the disease where good drugs go to die. Did you see what lupus did to Genentech and Biogen Idec's BIIB Rituxan this week? Eek!

La Jolla's drug is called Riquent. It failed a phase III program and an FDA submission once before, so this is a do-over of sorts. I have a hard time believing the second shot will be any more successful than the first. La Jolla's stock price (under $2) is telling you the same thing.

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