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Biotech / Medical : AMLN (DIABETES DRUGS) -- Ignore unavailable to you. Want to Upgrade?


To: D. Kim who wrote (953)11/18/1997 9:50:00 PM
From: Henry Niman  Respond to of 2173
 
D. Kim, I read the Barron's article when it first came out and saw nothing new.



To: D. Kim who wrote (953)11/19/1997 1:41:00 PM
From: D.Right  Read Replies (2) | Respond to of 2173
 
Dear D.Kim:

Of course Henry won't see anything new here, this is a positive article about the drug pramlintide from AMLN and Henry doesn't like pramlintide or anything AMLN may have for reasons he kept to himself. The only reason he posts here is to tell people AMLN is a really bad investment choice and they should all switch to LGND.

I agree that most of the information in that article was available before if you have followed the company closely. But that is not the case for potential new investors who happened to read Barron that day. I am sure Henry would send out many many e-mails all over the places if it had been for LGND with or without new informations.

What is new in the Barron's article, however, is that it was the first time we know how diabetic patients feel after they took pramlintide. It is true that you have to have the numbers for a FDA approval, I am sure AMLN is working for those number right now in the on-going trials, but it is what the drug can do for patients like the ones in Barron's article that will decide how successful a drug will be after the approval. And the article did tell us that.

Good day

D.Right



To: D. Kim who wrote (953)11/20/1997 11:12:00 AM
From: Henry Niman  Read Replies (2) | Respond to of 2173
 
D. Kim, The original press release also indicated that 75% of the patients elected to continue to take the drug. The news that came out of the original AMLN release was not viewed favorably on the street, because the reponse was weak. Here's another competitor with a drug that knock's glycocylated hemoglobin down 2%, which is markedly more than Pramlintide's average. In the past I have recommended AMLN, but the news and price seem to be heading in the wrong direction. This news may be contributing to AMLN's weakness this morning:

By Lauran Neergaard
The Associated Press
B E T H E S D A, Md., Nov. 19 -
Diabetics may soon get a new
medicine that promises to help their
bodies produce insulin only when
they need it, at mealtime.
Scientific advisers to the Food and Drug
Administration recommended Wednesday
that Novo Nordisk's repaglinide be
approved to treat Type II diabetes.
But the doctors cautioned they weren't
sure how to prescribe the drug-and asked
if diabetics really would opt to take a drug
three times a day, 15 minutes before every
meal, when older medicines work with just
one tablet a day.
"You need insulin when you eat,"
responded company scientist Dr. Peter
Damsbo. "No meal, no tablet."
But Novo Nordisk never proved that
taking medicine only with meals actually
improved diabetes care, panel chairman Dr.
Robert Sherwin of Yale University said after
the 8-1 vote.

Not Necessarily Better
"All of us had some mixed emotions" about
backing repaglinide, he said, noting that
scientists don't understand how it works or
even know the best dose. "The drug was
comparable to other drugs already on the
market. Superiority wasn't clearly
demonstrated."
The FDA is not bound by advisory
committee decisions, but typically follows
them. Because repaglinide, to be sold under
the brand name Prandin, is the first in a new
class of diabetes drugs, the government has
promised a quick decision.
About 18 million Americans have
diabetes. Type I diabetes typically strikes
children, who cannot produce insulin and to
survive need lifelong, daily shots of the
hormone, which converts blood sugar into
energy.
The vast majority of diabetics-16
million-have Type II, also known as the
noninsulin-dependent type that usually hits in
adulthood. The body's natural insulin
gradually loses its ability to work, letting
blood sugar rise. Unchecked, that can cause
kidney damage, blindness, heart disease and
other complications.
These Type II diabetics are the ones
repaglinide is supposed to help. They
already can choose other once-a-day pills to
boost insulin production and decrease blood
sugar.

Produces Insulin Quicker
A healthy body quickly produces insulin after
a meal to promptly digest blood sugar. Type
II diabetics take longer to produce that
insulin, and it takes longer for it to work.
Once-a-day pills increase insulin
production daylong-not just when blood
sugar skyrockets after meals, but even when
blood sugar naturally dips low, as in patients
who don't have a snack before going to bed.
The theory is that a drug that worked only at
mealtime might decrease the risk of serious
hypoglycemia-when patients' blood sugar
actually drops so low that they could pass
out, even enter a coma.
In Novo Nordisk's studies, repaglinide
patients had a 60-milligram drop in their
overall blood sugar levels, similar to other
diabetes drugs, said company scientist Dr.
Martin Edwards. Patients had a roughly 2
percent drop in glycosolated hemoglobin
, a
measure of how high blood sugar affects
diabetics' hemoglobin over time.

May Benefit Light Eaters
Diabetics who tend to skip meals might
benefit from repaglinide, FDA adviser
Sherwin said.
But "did they really prove it mattered?
Not really," he said. "Most patients would
prefer to be on once-a-day medication."
In safety studies of 1,200 patients, no
one suffered hypoglycemia serious enough to
require medical attention. About 1.5 percent
of patients dropped out the study citing mild
to moderate hypoglycemia, compared with
about 2.5 percent of "control" patients who
quit taking older diabetes medicines for the
same reason.
Repaglinide patients suffered slightly
more cardiovascular side effects-including
five patients who died of heart attacks
compared with just one heart attack death
among control patients taking other diabetes
medicines. But the FDA advisers split on
whether the findings were chance or a
serious risk, and Novo Nordisk wants to
study the question in depth while it sells the
drug.



To: D. Kim who wrote (953)11/20/1997 12:37:00 PM
From: schadenfreude  Read Replies (2) | Respond to of 2173
 
For the sake of argument, let's say that the Amylin product does become a $500 million product. The Barron's article estimates that this would net $2-3 per share to Amylin. With 32 million shares, thats $64-96 million. If this were true, Amlyin's stock is worth more than the current $7/share, but not a lot more. First, the earnings stream is about five years out since the drug won't be approved until 2000. And second, patent protection doesn't last forever--we're not talking about a perpetuity here. The company would of course be worth more if they have other products in the pipeline, but from what I've heard, this is a one-trick pony.

If Barron's earnings estimates are true, then M Murphy's long-term projection of $100/share is all wet. I am missing something here?

While the stock is down quite a bit from its highs and seems to be under pressure from year-end tax selling, I'm not sure the risk-reward relationship is favorable.