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


To: jopawa who wrote (728)12/4/1998 3:23:00 PM
From: Anthony Wong  Respond to of 2539
 
John, IMHO MRK is a trading buy here to hold until another run-up on Vioxx approval, after which I'll switch to anothr big pharma. Unless they have other potential blockbuster drugs coming out in 1999 and 2000, investor sentiment on MRK would turn negative when more and more of their drugs are near patent expiration (profit on those drugs would be cut in half and MRK won't be growing as fast as Pfizer and some other big pharmas).

Anthony



To: jopawa who wrote (728)12/7/1998 8:50:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 2539
 
Outfoxing pathways of pain 'COX-2' drugs are easier on stomach
US News - Science & Ideas 12/14/98

MEDICINE

BY SUSAN BRINK

It was a vote with resonance from Wall Street to the
homes of America's 23 million arthritis sufferers.
Last week, in a stuffy hotel ballroom in Silver
Spring, Md., the Food and Drug Administration's
arthritis advisory committee's nine members
unanimously recommended approval of Celebrex,
G. D. Searle & Co.'s new arthritis drug. Those in
the standing-room-only crowd of more than 300
industry scientists and market analysts stood up to
watch the show of hands, and many reached for
their cell phones the minute the vote was tallied to
capitalize on the news. This is a nearly $2
billion-a-year market they're talking about.

But one arthritis-care expert remains skeptical. As
a rheumatologist and spokesman for the Arthritis
Foundation, Doyt Conn is as eager as anyone to
see arthritis sufferers spring from their rocking
chairs. But he says "time will tell" whether
celecoxib, a new class of drug, to which Celebrex
belongs, that targets arthritis inflammation and pain
with fewer side effects, is worth the hoopla.

Conn's concern is that the drug, while it has been
tested in more than 14,000 people (about 10 times
more than typically submitted to the Food and Drug
Administration, though no single patient has taken
it for longer than about a year), may present
unexpected side effects when used by millions for
many years. "There's no reason to expect them to
be any better than what we've already got. But
there's good reason to hope they're safer," Conn
said.

Bad enzyme. Doctors have long known that
nonsteroidal anti-inflammatory drugs, or NSAIDs,
can relieve arthritis pain by blocking production of
cycloöxygenase, or COX for short, an enzyme that
helps make prostaglandins, the substance largely
responsible for the pain and inflammation of
arthritis. Philip Needleman, then chair of the
pharmacology department at Washington University
in St. Louis, was instrumental in figuring out in the
1980s that two enzymes help make prostaglandins,
dubbed COX-1 and COX-2, and that COX-2 was the
driver of the disease's symptoms. Needleman
moved to Monsanto Corp., parent company of
Searle, and, with an army of chemists, began
working on a theory of "good enzyme, bad
enzyme," to develop a drug that targets only
COX-2. It doesn't affect COX-1, which protects the
digestive system from its own erosive acids.
Therein lies the benefit of COX-2 inhibitors: They
ease pain just like common NSAIDs, including
aspirin and ibuprofen, but without interfering with
COX-1, thus reducing the risks of serious side
effects like bleeding ulcers. About 107,000 people
are hospitalized each year for upper gastrointestinal
complications resulting from NSAID use; 16,500 of
them die.

The theory that COX-2 inhibitors don't interfere with
COX-1's stomach-protecting ability has proved
largely true. But competitors of Searle, including
Robert Palmer, group director of rheumatology
clinical research and development for SmithKline
Beecham, are eager to articulate the complications.
Palmer points to a growing body of research that
suggests that COX-1 and COX-2 may have
overlapping functions and that neither is purely
"good" or "bad." The FDA advisory committee urged
that the drug's label warn of potential harm to the
stomach and intestines, even though the risk is
likely to be smaller than that of available arthritis
drugs.

Celebrex awaits final FDA approval, likely by
year-end. (Merck & Co. is close behind with Vioxx,
a similar drug.) Celebrex will treat both
osteoarthritis, which affects some 21 million people
and results from wear and tear on the joints, and
rheumatoid arthritis, an autoimmune disorder that
affects about 2 million people.

Needleman, now co-president of Searle and chief
scientist at Monsanto, is a rare scientist who has
seen an idea through, from tissue in a petri dish to
the imminent prospect of a new drug on the
pharmacy shelf. "In science, a hypothesis is
something you usually throw away," he said. "This
one didn't melt."

usnews.com



To: jopawa who wrote (728)12/8/1998 5:09:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 2539
 
Merck to Update Outlook for Vioxx at Analysts Meeting Wednesday

Bloomberg News
December 8, 1998, 3:37 p.m. ET

Merck to Update Outlook for Vioxx at Analysts Meeting Wednesday

Whitehouse Station, New Jersey, Dec. 8 (Bloomberg) - Merck &
Co., the world's biggest drugmaker, will give an update on the
outlook for its next potential blockbuster, the experimental
arthritis painkiller Vioxx, at an analysts' meeting tomorrow.

Merck is lagging competitor Monsanto Co. in bringing its
entry in the new class of painkillers to market. Monsanto's drug,
Celebrex, could win FDA approval as within a month.

Merck is expected to discuss tomorrow whether the FDA will
grant a priority review for Vioxx. If it does win accelerated
review, it could be introduced about six months after Monsanto's
Celebrex. If not, it could follow by about a year.


Merck, based in Whitehouse Station, New Jersey, rose 1/8 to
157 7/8 in afternoon trading.

At Wednesday's meeting, Merck also will discuss marketing
plans for its drugs, said John Doorley, a company spokesman.

Merck's top-selling product, the cholesterol reducer Zocor
has been losing share to Warner-Lambert Co.'s similar medicine
Lipitor. Merck last month announced a money-back guarantee for
Zocor, allowing refunds for those who take the drug and fail to
reduce their cholesterol as expected.

Lipitor is marketed by Pfizer Inc. through an agreement with
Warner-Lambert. Pfizer, considered one of the drug industry's
best marketers, also will help Monsanto Co. sell Celebrex, its
rival to Merck's Vioxx.

Merck's Best Chance

Both drugs are expected to easily reach annual sales of $1
billion. Merck's Vioxx is seen as Merck's best chance of keeping
profits rising after it loses patents on some of its best-selling
medicines. By 2001, Merck will lose the patent on four drugs that
had more than $5.3 billion in combined 1997 sales. These include
the high blood pressure medicine Vasotec with $2.5 billion in
sales.

Merck suffered a setback last week to its plan to look to
its own pipeline to offset these patent expirations. Monsanto Co.
told an FDA advisory panel that its Celebrex may be a once-a-day
pill, matching an advantage that Merck had claimed for Vioxx.


Vioxx and Celebrex are both so-called Cox-2 drugs. They
appear to work by targeting an enzyme, cyclooxygenase-2, involved
in pain and swelling. Unlike existing painkillers, a Cox-2
inhibitor doesn't suppress a related enzyme, Cox-1, that helps
protect the stomach from its own acid.

As a result, researchers say, the Cox-2 drugs should offer
the same benefits as existing painkillers with fewer side effects
such as bleeding and ulcers for people who take pain medication
for chronic conditions such as arthritis.

The development of the Cox-2 drugs shows how the search for
new medicines has changed in the past decade or so, said Bennett
Shapiro, who leads Merck's basic drug research. Drugmakers once
screened compounds at random to see if they could become
medicines. Now, they look more closely at targets, such as
enzymes, and try to find a way to block them, he said.

Merck 'Mantra'

Merck moved quickly on the Cox-2 project, Shapiro said. The
research was assigned to its Montreal lab where scientists had
developed another promising Merck drug, the once-a-day asthma
pill Singulair. At times, about 60 to 70 scientists, or two-
thirds of the available researchers, worked on the Cox-2 drug.

Recruiting scientists to work on the project was not
difficult, Shapiro said. ''On projects that are going well,
people smell blood in the water,'' he said.

Several likely drug candidates were passed by as Merck
looked for one that would hit Cox-2 and only Cox-2, Shapiro said.
''You never hit Cox-1,'' he said. ''That's really important.''

The drug the company finally came up with meets what Shapiro
termed ''the classic Merck mantra.''

Merck wants its drugs to be highly specific, meaning they
hit their targets in the body fairly precisely. Side effects
often are the result of drugs interfering with compounds in the
body that are similar to their target. The Merck ''mantra'' also
means making drugs that are taken just once a day and in low
doses.

''Vioxx is that kind of drug,'' Shapiro said.

Research has long indicated a possible link between
painkillers and reduced risk of Alzheimer's disease and colon
cancer. Chronic use of older drugs posed enough of a risk that
long-term studies of such disease prevention were not done. With
the Cox-2 drugs, Merck and Monsanto both are doing this kind of
research.

''Now you can move into an area you could never touch
before,'' Shapiro said.

Merck used last year's meeting to unveil early research on a
new depression drug that may work without some of the side
effects of available medicines such as SmithKline Beecham Plc's
Paxil. Antidepressants are some of the world's best-selling
drugs. Eli Lilly & Co.'s Prozac has annual sales of more than $2
billion and Paxil and Pfizer Inc.'s Zoloft each top $1 billion.

--Kerry Dooley in Boston through the Washington newsroom (609)