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Biotech / Medical : CEPH -- Ignore unavailable to you. Want to Upgrade?


To: Doug Kaiser who wrote (589)3/9/1998 1:55:00 PM
From: KurtVedder  Read Replies (1) | Respond to of 998
 
<<"The association of IGF-1 and prostate cancer risk is stronger than that of any previously reported risk factor, including steroid
hormone levels,">>

Prostate cancer is the least of an ALS patient's worries.

<<Toni Claudio of UBS, has repeatedly pointed out that more ALS patients have died on
the drug than have improved>>

This point has already been addressed by the FDA and they are satisfied that the drug is safe and patients do not die from Myotrophin rather they are dying from ALS.
<<"IGF-1 is a dangerous drug with numerous serious side effects, and it has failed in many clinical trials,">>

It has not failed in "many" clinical trials. It has not had robust results in some neuropathy trials but we are not looking for approval in those applications yet.

<<"These are not good side effects for ALS patients, either," says Claudio.>>

How nice of Toni Claudio to care so much. But if Claudio has seen an ALS patient suffer as I have seen then that statement would never have been made. I do not make these statements because I am long on the stock. I just see Toni Claudio statement's as having some ulterior motive. Remember, Claudio was very bullish on Regeneron's BNDF.

Seem's like sour grapes. Instead I would speak to Tim Wilson of UBS. He is quite bullish and his expertise is in this field.

Good Luck.



To: Doug Kaiser who wrote (589)3/10/1998 11:59:00 PM
From: KurtVedder  Respond to of 998
 
As I have said before, Toni Claudio was bullish on BDNF from Regeneron when she worked for Smith Barney. At the time, SB was an underwriter for Regeneron and Claudio was an analyst (amateur analyst). Her job was to bad mouth Cephalon. This info in Nature Biology is hardly news.

Here is a story that may help you understand her better:

06/07/96 Two Analysts Are Creating Quite A Stir Over ALS Drug

By Elyse Tanouye
Staff Reporter of The Wall Street Journal

Toni Claudio and Reijer Lenstra, a married couple and both Wall Street analysts, have waged a combative and controversial campaign for much of the past year against biotech boutique Cephalon Inc. and its experimental drug for Lou Gehrig's disease.

Former medical scientists who now work for Smith Barney Inc., Drs. Claudio and Lenstra assert that Cephalon is using flawed clinical studies in pushing for approval of the drug, Myotrophin. Today, the controversy could reach a new level of intensity: An advisory panel to the Food and Drug Administration is expected to give its opinion on whether the drug, is safe enough to be distributed to patients even before formal approval from the FDA.

A thumbs-up from the panel could accelerate full FDA approval, letting Myotrophin compete in an estimated $400 million world-wide market and boosting the fortunes of tiny Cephalon, based in West Chester, Pa., and its much bigger partner in developing the drug, Chiron Corp. of Emeryville, Calif.

A rejection, on the other hand, would present big problems for Cephalon, damage Chiron -- and vindicate the two analysts' decidedly off-the-Wall Street approach of using the skills and discipline they developed as scientists to scrutinize the medical claims of the companies they follow, blowing whistles when they find fault. When the FDA panel convenes in Bethesda, Md., Drs. Claudio and Lenstra plan to be in the audience, sitting near the front
row. Among other criticisms, Dr. Claudio views the number of people in Cephalon's test as too small -- a few hundred compared with about a thousand in rival drug trials -- and its measurement methods as too subjective.

However, critics, including other analysts, accuse the pair of waging a vendetta aimed at profiting from Cephalon's failure -- pointing out that Smith Barney represents a Cephalon rival -- Regeneron Pharmaceuticals Inc. But Drs. Claudio and Lenstra counter that they started criticizing Cephalon long before Smith Barney agreed last fall to help Regeneron raise cash.

Cephalon executives say they are mystified by the analysts' assertions. "It would be an understatement to say that we have found their criticisms and interpretations of our findings frustrating," a spokesman says. "They seem determined to discredit us. We can't understand why."

Lou Gehrig's disease, also known as amyotrophic lateral sclerosis, is a debilitating and eventually fatal malady, and the company that comes up with an alleviating medication will surely profit. But finding such a drug is fraught with risks, and Cephalon's stock price, which hit a high of $41.50 a share in December, closed yesterday on the Nasdaq Stock Market at $23, unchanged, reflecting investor uncertainty.

One of the major reasons for investor uncertainty has been the blunt -- and highly publicized -- views of Drs. Claudio and Lenstra. The pair met in 1989. Dr. Claudio, who is now a tenured professor of neurobiology at Yale University, met Dr. Lenstra after giving a lecture in Geneva, where he was a molecular biologist for the pharmaceutical company known then as Glaxo Holdings PLC. Days later, they both happened to take the same train to Paris; six
weeks later they married.

Dr. Lenstra (his first name is pronounced RYE-er) is 40 years old, of Dutch nationality and serious; Dr. Claudio is 41, California-born and animated. Dr. Lenstra, a physician with a doctorate in molecular biology, went on to get a master's degree in business administration at Columbia and became a biotech analyst in San Francisco in 1992. In 1994, he joined Smith Barney in New York; and in the same year, Dr. Claudio, on leave from Yale, went to work
with her husband at the securities firm. Their approach soon put them at odds with a number of publicly held biotech companies -- among them, Genzyme Corp., MedImmune Inc. and Hybridon Inc. Wall Street analysts largely earn their keep by spotting stocks with potential that they can recommend for purchase. But rookie analysts Claudio and Lenstra kept finding stocks they didn't like.

While the two analysts hail biotech drugs that can change the course of medicine, they say they are often confronted by products hyped in "slick press releases." They deplore the cozy relationships some companies have with doctors and analysts. And they never mince words, characterizing some biotech companies as "snake-oil salesmen" preying on "desperate patients."

Homing in on companies' statistical methods, they talk of scientific rules being violated and key adverse data being omitted. The barbs have infuriated the companies they criticize, rival analysts and others, who variously accuse the pair of being holier-than-thou, unscientific and hysterical -- albeit usually off the record. "I think Claudio is off the wall, she's misleading people," says Theodore Munsat, a Boston specialist in Lou Gehrig's
disease. "Don't let that Yale professor business throw you off base -- it's just a title. It doesn't say much about her qualification to do what she's doing."

The final quote is from Dr. Munsat, as you can see. He is a leading-if not THE leading-doc specializing in ALS. In other words, Toni Claudio is a wacko. Incidentally, the meeting where Dr. Claudio was sitting in the "front row" was the one where the FDA voted 11-0 in favor of Myotrophin. Obviously, her views were not shared by the FDA or the Advisory Panel.