Replies to post #2023 on Biotech Values

[DewDiligence]

>> I couldn't disagree with you more on the tarceva data. When you take into account it's a median number, some have virtually no response while others are outliers with tremendous responses, the drug is a major advance. <<

I agree that the median may not be the best indicator of the clinical benefit, but you are assuming that the Tarceva arm had significant “outliers” to a greater extent than the placebo arm.

We do not know that yet!

It is quite possible that the respective survival curves for the Tarceva and placebo arms separate nicely at the 50% level (which is used to calculate the median survival) and then quickly collapse on one another. E.g., at the point on the curves where, say, 10% of patients are still alive, the Tarceva curve may have no little or no incremental duration relative to the placebo curve. We will know more when the detailed data are released at ASCO, but I think it’s premature to declare that Tarceva is a “major advance.”

Finally, I must correct your statement about Genentech. I think they are a great company –my beef is with the colossal valuation. Regards, Dew

[DewDiligence]

Zelnorm: another drug with marginal benefits:

[Zelnorm doesn’t treat a life-threatening condition but rather “irritable bowel syndrome,” which some doctors don’t even think is a real illness. It’s peculiar that the troublesome side effect is severe diarrhea, because diarrhea is one of the symptoms this drug is supposed to ameliorate.

Special note to ‘rkrw’: I pick on everyone –even Novartis, which I happen to own.]

http://biz.yahoo.com/rc/040428/health_novartis_zelnorm_3.html

>>
Novartis bowel drug to carry new warning-US FDA

WASHINGTON, April 28 (Reuters) - Novartis AG's (NOVN.VX) (NYSE:NVS - News) irritable bowel drug Zelnorm will come with a new warning that patients could experience severe diarrhea that requires hospital treatment, U.S. regulators said Wednesday.

The drug's new label also will caution about cases of reduced blood flow to the intestines, or ischemia, in patients who took Zelnorm, the Food and Drug Administration said.

It is not clear if Zelnorm played any role in the approximately 23 ischemia cases reported to regulators, said Dr. Robert Justice, director of the FDA's gastrointestinal drugs division. Three of the patients needed surgery and four died, he said.

Sixteen Zelnorm patients were hospitalized for dehydration from severe diarrhea, Justice said.

Patients treated with Zelnorm should stop taking the drug immediately and contact their doctors should they develop new or more severe stomach pain or blood in the stools, Justice said.

"At the present time, we believe the benefits (of Zelnorm) outweigh the risks. We will continue to monitor" possible side effects, Justice said in an interview.

Swiss pharmaceutical company Novartis and some industry analysts had predicted peak annual sales of prescription Zelnorm would hit $1 billion worldwide.

Novartis shares fell 76 cents, or 1.7 percent, to $43.53 in afternoon trading on the New York Stock Exchange .

The company is sending letters with the updated information to more than 450,000 doctors and pharmacists, spokeswoman Carrie Callahan said.

Severe diarrhea is rare, Callahan said. In clinical trials, it occurred in only 0.04 percent of patients.

She also said the rate of bowel ischemia cases reported after the drug's approval in July 2002 was small and similar to what is expected in the general population.

But consumer watchdog Sidney Wolfe said Zelnorm is too dangerous to stay on the market and only slightly more effective than a placebo. He had urged the FDA not to approve the drug in the first place.

"If a drug is actually more dangerous than a placebo and not much more effective, it is a very bad trade-off," Wolfe, head of Public Citizen's Health Research Group, said in an interview.

Irritable bowel syndrome, or IBS, causes alternating bouts of diarrhea and constipation as well as abdominal pain. Zelnorm is approved for short-term treatment of women with IBS whose main symptom is constipation.

Another irritable bowel drug, GlaxoSmithKline Plc's (London:GSK.L) Lotronex, was pulled from the U.S. market after reports of fatal cases of bowel ischemia. The FDA later allowed limited sales to resume.

Lotronex is approved for treating women who suffer mostly from diarrhea.
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