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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Little Gorilla who wrote (7721)5/21/1999 2:20:00 PM
From: Brander  Respond to of 9523
 
Not entirely correct.

The dosage recommendation of Celebrex for treatment of osteoarthritis is 200mg per day as a single dose or 100mg twice a day. The dosage for rheumatoid arthritis is 100 to 200mg twice a day.



To: Little Gorilla who wrote (7721)5/21/1999 5:18:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
FDA Okays ‘Super-Aspirin'
Vioxx Meant to Fight Pain Without Side-Effects

N E W Y O R K, May 21 — The U.S. Food and
Drug Administration has given Merck & Co.
approval to market its long-awaited
“super-aspirin” Vioxx to treat pain associated
with osteoarthritis and acute general and
menstrual pain, the pharmaceutical giant said
today.
Vioxx will now compete with Monsanto Co.'s Celebrex,
the first in a new class of revolutionary drugs designed to
battle pain and inflammation without the side effects of
aspirin and related drugs such as ibuprofen, which can
cause deadly internal bleeding.
An estimated 16,000 people a year die from deadly
ulcers caused by conventional painkillers, which block the
COX-1 enzyme that protects the stomach lining.

Similar Pricing to Celebrex
New Jersey-based Merck said Vioxx will cost patients
between $2.38 and $2.52 per tablet, competitive with the
$2.42 price of Celebrex, which was launched in January.
Vioxx is expected to be in pharmacies before mid-June.
Despite Celebrex's head start and robust sales, Merck
has said Vioxx could enjoy a possible marketing advantage
over its rival because it is “a true once-a-day drug.”
Celebrex is taken once or twice a day for osteoarthritis,
the breakdown of joint cartilage from normal wear and tear,
and twice a day for rheumatoid arthritis, an auto-immune
disease caused when the patient's body attacks the joints.

Additional Applications
Celebrex is not approved for acute chronic pain, such as
from dental surgery, which Merck has said could give
Vioxx another marketing edge.
Merck is counting on Vioxx, expected by analysts to be
a multibillion-dollar product within several years, to help the
company overcome the loss of U.S. patent protection on
five of its key drugs by 2001.
Combined 1998 sales from three of those drugs were
more than 25 percent of Merck's drug sales last year.
Merck said the recommended dose for osteoarthritis is
12.5 milligrams daily, with some patients possibly benefiting
from 25 mg daily. For acute pain, the recommended Vioxx
dose is 50 mg once daily.
Use of Vioxx for more than five days has not been
studied.
Like Celebrex, Vioxx will carry a label advising patients
to be alert for ulceration and bleeding that can occur
without warning.

abcnews.go.com



To: Little Gorilla who wrote (7721)5/21/1999 5:24:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
A Bloomberg update:
news.com

Excerpts:

Additional Markets

Celebrex also has been approved for sale in eight additional
markets since the beginning of 1999: Peru, Brazil, Canada,
Mexico, Colombia, Argentina, Switzerland and Hong Kong. It is
awaiting European approval.

The FDA gave Merck's drug little, if any, advantage over
Celebrex on the prescribing label, said Jeffrey Chaffkin, an
analyst with PaineWebber.

''The labels are essentially the same,'' he said.

The good news for Merck is that the FDA didn't highlight
questions about Vioxx's potential to cause water retention,
Chaffkin said. Water retention, or edema, can be a concern for
doctors treating elderly patients who already are at higher risk
for some heart problems.

Still, Merck had hoped its extensive studies would let it
say more about Vioxx's apparent lower risk of causing ulcers and
irritation in the gastrointestinal tract, Chaffkin said.

''They didn't get as strong a label in the GI as they
wanted,'' Chaffkin said. ''Right now, in terms of sheer revenue,
I think that Celebrex will always have an advantage.''

Chaffkin estimated peak sales of Celebrex at $2 billion to
$3 billion, with Vioxx more likely to sell in the bottom of that
range.

Single Dose

Some analysts see advantages in Merck's drug. While
Monsanto's pill can be used once a day, some patients take it
twice. Merck's drug is a ''true'' once-a-day pill, analysts have
said.

''There may be some cost advantage (to Vioxx); once-daily
dosing for Vioxx could be less expensive,'' said CIBC World
Markets analyst Steven Gerber. ''At present, we think Merck has
the edge.''

Gerber also said the approval is a chance for Merck to
showcase its Merck-Medco Managed Care division, which provides
pharmaceutical benefit services.

''This is also an interesting opportunity for Merck to use
the power of its Medco division,'' Gerber said. ''We think
they'll do a very good job with this product.''

To catch up with the team of Pfizer and Monsanto, Merck is
likely to use ads directed at consumers as well as the more
traditional ones placed in medical journals. It also will
probably give out thousands of free Vioxx samples, a tactic
Pfizer and Monsanto have used to promote Celebrex.

Drug 'War'

''It's going to be war out there,'' said Jack Lafferty, an
analyst with U.S. Trust, which holds about 9 million Merck
shares, according to regulatory filings.

In December, Merck announced that it would hire 700 new U.S.
sales representatives, adding to a then-current sales force of
about 4,000.