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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Henry Niman who wrote (18442)4/1/1998 4:51:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
Still looking for more merger news (GLX & AHP were both fairly strong today). Here's an update on market response to AHP & IPIC due to Redux report:

AHP climb loses power, Interneuron rallies

NEW YORK, April 1 (Reuters) - The rally in American Home
Products Corp.'s stock, on positive results from a study of its
weight-reduction drug Redux, lost momentum Wednesday as the
market viewed the news as a "small positive," according to
analysts.
However, Interneuron Pharmaceuticals Inc. IPIC.O
sustained its sharp stock rise in related trade because the
company is smaller than AHP, giving the news a more significant
impact, they said.
In afternoon New York Stock Exchange trade AHP shares were
up 1/2 to 95-7/8, off the 12-month high 97-3/4 reached last
month.
The opening of NYSE trade in the shares was delayed this
morning due to an order imbalance, with the stock then
indicated to move as high as 98.
Meanwhile, Nasdaq-listed Interneuron held a 20 percent
rise, up 2-1/8 at 12-9/16.
AHP and Interneuron said Tuesday that a study of Redux had
found that the incidence of cardiac valve abnormalities among
users of the drug was far less than estimates previously
reported.
Redux, manufactured and marketed by Interneuron and AHP's
Wyeth-Ayerst unit, was withdrawn from the market last
September.
ABN Amro pharmaceutical analyst Mario Corso said the
companies had taken a step toward "defending their position in
the whole obesity drug scandal."
"They conducted the study which showed heart valve damage
at a much lower level than the study reported to the FDA (U.S.
Food and Drug Administration), which led to the market
withdrawal of the product," the analyst said.
Corso added, "The market is interpreting it as a small
positive. I don't think anything definitive came out of the
study for American Home. It was short-term in nature, while in
the (earlier) Mayo Clinic study patients were on the drug six
months or longer, so that could be an eventual point of
contention."
Wyeth-Ayerst and Interneuron marketed the drug fenfluramine
under the brand name Pondimin and the drug dexfenfluramine
under the brand name Redux.
On Sept. 15, 1997, Wyeth-Ayerst voluntarily pulled both
drugs off the market after the FDA presented to the company
"new and preliminary information about possible heart valve
abnormalities in patients using these products," according to
Wyeth-Ayerst.
Scores of lawsuits have been filed against the companies
related to the compounds and alleged heart valve damage.
David Saks, Gruntal & Co pharmaceutical analyst, said he
had raised his AHP 12-month price target to $115 per share from
$104.
"I made the case that what everyone was forecasting in
terms of the size of the (potential) litigation (awards) has
now dramatically shrunk to a much smaller price, though it will
not be resolved for many, many years," Saks said.
"This (the new study) is not going to resolve it, but the
science will help reduce the worst case. Whatever the number
is, it is no longer as big as a black hole," he said.
Announced the results of the new study, the companies said
a sustained-release form of dexfenfluramine in more than 1,000
patients had shown no significant increase in the prevalence of
heart valve regurgitation after two to three months.
Valvular regurgitation is the backward leakage of blood,
which can decrease blood flow to the body and increase the
workload of the heart.

REUTERS
Rtr 14:44 04-01-98



To: Henry Niman who wrote (18442)4/2/1998 6:44:00 AM
From: Henry Niman  Respond to of 32384
 
Here's more on the new Redux study and limited liability:
Dow Jones Newswires -- April 1, 1998
AG Edwards Analyst Says New Redux Study Shows 'The
Facts'

NEW YORK (Dow Jones)--A drug analyst at A.G. Edwards & Sons Inc.
said a new study on American Home Products Corp.'s (AHP) Redux
weight-loss drug is as "close as we're going to get to the facts."

Redux, which was developed by Interneuron Pharmaceuticals Inc. (IPIC)
and marketed in the U.S. by American Home Products, was pulled from
the market last September because reports linked the drug to heart-valve
leakage.

However, a recent Georgetown University Medical Center study found that
patients taking the diet drug experienced no significant increase in heart
valve abnormalities when compared with patients taking a placebo.

"It appeared they had those abnormalities, they did not know for sure and
there was no clinical study and no evidence," Kenneth Nover told CNBC
Wednesday. "Now we have a clinical study study that shows that it does
not appear to be the case."

He said he does not believe the drug will be brought back to the market.
However, the new study cuts the company's liability, which has been
reflected in the stock price.

"There was some liability, but we believe it was overdone ..." Nover said.

-Nancy Fonti; 201-938-5171



To: Henry Niman who wrote (18442)4/2/1998 7:04:00 AM
From: Henry Niman  Respond to of 32384
 
Here's what AP had to say about the new Redux study (voting at the CNBC site is 2-1 indicating that the FDA pulled it too early):
THE STUDY, conducted at Georgetown University,
appears to largely exonerate Redux, a prescription appetite
suppressant. It found the medicine is no more likely than
sugar pills to seriously harm the heart during the two or
three months that most people took it.
However, it did not rule out the possibility that taking
Redux for many months - as the drug was intended to be
used - could have harmed people. It also did not examine
whether the chemically similar phen-fen, which was pulled
from drugstores at the same time as Redux, is bad for the
heart valves.
"These results should be reassuring for the majority of
patients who have been on Redux," said Dr. Neil J.
Weissman, who directed the study.
His study is the first large, carefully controlled
experiment to see whether Redux truly caused the damage
that many suspected.
Wyeth-Ayerst Laboratories, which makes Redux and
fenfluramine - the fen of phen-fen - pulled both drugs off
the market at the request of the Food and Drug
Administration. The government acted after a Mayo Clinic
team reported 24 cases of heart valve problems among
people taking phen-fen.
Government agencies eventually gathered several
hundred cases of damaged heart valves among people
taking phen-fen and Redux. Such reports cannot prove that
the diet pills actually caused the valve damage. However,
the FDA estimated that one-third of people taking the diet
pills could have suffered significant heart valve damage as a
result.
Dr. Janet Woodcock of the FDA said that while the
study "is reassuring for people who took it for a short
period of time," the study does not settle the question of
what happened to those who used it longer. She said the
FDA believes this is where most of the harm occurred.
Dr. Curt Furberg of Wake Forest University, a
member of an expert panel assembled by Wheth-Ayerst to
help design studies of the drugs' effects, said the
Georgetown study "meets the highest scientific standards
we have."
The results were presented at a meeting of the
American College of Cardiology.
The study involved 1,072 overweight men and women
who had been involved in testing of a new,
sustained-release form of Redux. They were randomly
assigned to take regular Redux, the new form of Redux or
dummy pills. Neither the doctors nor the patients knew
which they were getting.
The study was stopped when Redux was taken off the
market. The patients were then give echocardiograms to
look at their heart valves. The doctors who read their scans
did not know which treatment they had received.
The results showed no significant difference in the three
groups in the kind of serious valve damage that the FDA
had warned of in Redux patients.
The study found mild or worse leaking of the aortic
valve in 5 percent of patients on Redux, 5.8 percent on
sustained-released Redux and 3.6 percent on placeboes. It
found moderate or greater mitral valve leaking in 1.7
percent on Redux, 1.8 percent on sustained-release Redux
and 1.2 percent on placeboes. The small differences were
not considered statistically meaningful.
The study showed - as heart experts already know
- that trivial valve leaking can be found with sophisticated
diagnostic machines in almost everyone, even though this
was somewhat more common among those getting Redux.
It found 50 percent of Redux users and 48 percent on
placebo had slight valve leakage.
The patients took the drug for an average of 77 days,
which is about the same as three-quarters of Redux patients
used the medicine.
The findings are unlikely to quell all of the furor over
Redux.
"This leaves the false impression that these drugs are
safe," said Guerry Thornton, an Atlanta attorney who has
filed lawsuits for women who used them.
Dr. Richard Bowen of Naples, Fla., who sent 122
cases of apparent valve damage to the FDA, said that while
new data are reassuring to those who used the drug briefly,
he worries that valve problems may be more common
among those who took the drug longer.
Dr. Philip J. de Vane of Wyeth-Ayerst said the
company has decided not to reintroduce Redux. "Given the
legal environment, it doesn't make any sense," he said.
Hundreds of lawsuits have been filed against the
company by people who took Redux or phen-fen.
Since 1995, 14 million prescriptions have been written
for fenfluramine or Redux, most of them for women. The
government estimates between 1 million and 5 million
Americans have taken the drugs.



To: Henry Niman who wrote (18442)4/2/1998 7:09:00 AM
From: Henry Niman  Respond to of 32384
 
Here's more from DJ:
Dow Jones Newswires -- April 1, 1998
Interneuron Shrs Up 63% In Two Days On Redux Data

NEW YORK (Dow Jones)--Shares of Interneuron Pharmaceuticals Inc.
(IPIC), coming off a 25% gain Tuesday, are up 31.1% in early trading
Wednesday, following the release of new data suggesting the diet pill
Redux may be safer than previously thought.

As reported, American Home Products Corp. (AHP), which recalled the
drug six months ago, late Tuesday released new data that may reassure
users of the drug, licensed to American Home by Interneuron.

The study of 1,072 people is the first of several sponsored by American
Home in an effort to exonerate its pills, which include both Redux and a
similar drug called Pondimin that was also recalled.

Skeptics say further studies may be needed before the safety issue can be
put to rest.

The drugs' problems began last September, when the Food and Drug
Administration said about 30% of patients using Redux suffered damage to
their heart valves.

Shares of Interneuron were recently up 3 1/4 at 13 11/16 on Nasdaq
volume of 2.1 million shares, eight times the daily average of 258,600.
American Home's NYSE-listed stock has gained 1 1/4, or 1.3%, to 96 5/8
on volume of 854,800 shares. Average daily turnover is 2.1 million shares.

-By Thomas Granahan; 201-938-5172



To: Henry Niman who wrote (18442)4/2/1998 7:16:00 AM
From: Henry Niman  Respond to of 32384
 
Still haven't found a news story on renewed merger talks. At the time of the CNBC story GLX was up 3. I believe it was the SBH CEO who indicated that hostile takeovers between large pharmas were very difficult. The report then indicated that AHP was now more attractive because of the new Redux study. I'm not sure if the report specifically said that a GLX/AHP combo was in the works, but AHP was definitely mentioned as being more attractive.

Of course a GLX/AHP would really leave SBH alone at the alter, but no one seems to writing about the above scenario. Drug stocks in general were strong yesterday, and I suspect that many combos are possible and talks of potential deals are fairly active.

Anyone see anything on a potential GLX/AHP merger?



To: Henry Niman who wrote (18442)4/2/1998 10:09:00 AM
From: Henry Niman  Respond to of 32384
 
Michael Murphy indicates that AHP is "desperately" looking for a partner. He doesn't think that the new Redux data will do much for IPIC because the study uses a new form of slow release Redux and most of the liability comes from Phen/Fen use. He laos indicated that lack or statistical significance was due to a small "n". He also cited another paper that was a small study, but it showed heart valve damage in 68% of diet drug users (not sure if it was Phen/Fen or Redux).



To: Henry Niman who wrote (18442)4/3/1998 8:22:00 AM
From: Henry Niman  Respond to of 32384
 
Latest Lehman Brothers report on GLX indicates SBH deal "still possible":
RESEARCH ALERT-Lehman repeats Glaxo 'outperform'

LONDON, April 3 (Reuters) - Lehman Brothers said on Friday its enthusiasm for British drugs group Glaxo Wellcome Plc <GLXO.L> had been reinforced by a meeting with the chairman and chief financial officer.

It issued a price target of 18 pounds, repeated its "outperform" rating on the stock and said an eventual deal with SmithKline Beecham Plc <SB.L> was still possible.

By 1000 GMT, Glaxo's share price gained 19p, or 1.1 percent, to 1750p in volume of 2.7 million shares.
According to a Lehman Brothers research note, Glaxo Chairman Sir Richard Sykes said the merger with SmithKline Beecham didn't happen -- despite the shared scientific goals -- because he could not build a unified management team, ie. a team which shared the same objectives and was balanced in its responsibilities.

Sykes told analysts that when the heat had died down everyone should "think again," the note said, implying that an eventual relationship between the two companies was not out of the question.

The message was reinforced, according to Lehman, by a subsequent comment from Sykes suggesting SmithKline needed a deal and Glaxo was the ideal partner.

Lehman said that, in the event of a deal, Glaxo would be worth well over 20 pounds per share.

05:33 04-03-98



To: Henry Niman who wrote (18442)4/3/1998 8:25:00 AM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
Here's more on Merger Mania:
Industry Consolidation: Wait and See

NEWTOWN, Pa.--(BW HealthWire)--April 2, 1998--Despite the recent breakdown of merger talks between Glaxo Wellcome and SmithKline Beecham, another wave of industry consolidation may be on the horizon, according to the spring 1998 issue of Scott-Levin's Pharmaceutical Quarterly.

From the creation of SmithKline Beecham in 1989 to the formation of Novartis in 1996, drug companies have long been part of a cyclical consolidation trend that arises periodically in response to market conditions. As new product pipelines dry up, earnings growth begins to slow and several blockbuster drugs go off patent, consolidation will no doubt be one strategy companies use to ensure survival in the next millennium.

Other stories covered in the current Pharmaceutical Quarterly:

-- PRILOSEC Going OTC: On the heels of a September accord to co-promote PRILOSEC, Astra Merck and Procter & Gamble agreed in December to market an over-the-counter version of the world's top-selling drug.

-- Baldness Market Getting Hairy: The December approval of PROPECIA, Merck's male pattern baldness therapy, sets the stage for a head-to-head battle with Pharmacia & Upjohn's ROGAINE in 1998.

-- REZULIN Weathers Liver Warnings: Will Warner-Lambert and co-promotion partner Sankyo follow the lead of Glaxo Wellcome in the United Kingdom and pull the oral antidiabetic REZULIN off the market. So far, despite concerns about the product's possible link to liver damage, the answer is 'no.'

Each issue of Pharmaceutical Quarterly also includes roundups of major activity by brand-name, generic, biotechnology and bioinformatic companies. For more information, contact editor Al Kilpatrick or publications coordinator Steve Shewbrooks at 215/860-0440; email@scottlevin.com.

Scott-Levin, a division of PMSI/Scott-Levin Inc., provides health care consulting, research and communications services to pharmaceutical companies worldwide.

CONTACT:

Scott-Levin, Newtown

Al Kilpatrick or Steve Shewbrooks, 215/860-0440

email@scottlevin.com

www.scottlevin.com

KEYWORD: PENNSYLVANIA

BW0126 APR 02,1998