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


To: BigKNY3 who wrote (6453)12/9/1998 12:28:00 PM
From: Jim Lamb  Respond to of 9523
 
Viagra sales at 3 Billion so far.??

Anthony posted this story. Here is a longer version. Look at the last sentence. Has to be a typo right?

--------------------------------------------------------------------------------
Tuesday December 8, 10:19 PM

Pfizer says no plans to launch Viagra in India
NEW DELHI, Dec 8 (AFP) - US drug manufacturer Pfizer said on Tuesday it had no plans to market the anti-impotence drug Viagra in India as the country had no strong patent laws.
"It makes no commercial sense to market Viagra or any other of Pfizer's new drugs in India in the absence of patent protection," Simon Campbell, chief of the company's research wing who discovered the drug told reporters here.

Since US patent laws do not yet apply in India, there is no legal barrier to indigenous manufacture of the drug.

Campbell said a government plan to grant exclusive marketing rights for five years to multinational companies was "not entirely satisfactory."

"Five years is too short a period for any drug firm to recover its investments," Campbell, currently in India to attend a global conference, was quoted by the Press Trust of India as saying.

He said the company spent an average of about 500 million dollars on a new drug to be developed over 13 years of research and clinical trials before actually being certified for marketing.

"It took 13 years to develop Viagra. Unless we have patent protection it makes no commercial sense to market the drug as the company has to recover the investments made on research in developing it," he said.

"Research on developing new drugs is high risk business and only one out of 10 drugs being researched actually finds its way to the market," he said.

Viagra has been hailed as the most important breakthrough to date in the treatment of male impotence. Trials suggest it helps seven out of 10 impotent men to have sex and works eight times out of 10.

The phenomenal success has, however, been overshadowed to a degree by the unexpectedly high number of deaths attributed to the drug.

In the United States alone some 69 deaths, mostly from heart attacks, have been linked to Viagra by the Food and Drug Administration.

Viagra is banned in India and sells on the black market for 500 rupees (12 dollars) a pop, a steep sum in a poor country. At least four Viagra-related deaths have been reported across the country.

"Viagra to me is not a recreation drug that boosts a man's potency but a drug that restores a normal sexual life to people with erectile dysfunctions," Campbell said.

He said the drug had earned the company about three billion dollars since its launch.



--------------------------------------------------------------------------------



To: BigKNY3 who wrote (6453)12/9/1998 2:52:00 PM
From: Anthony Wong  Respond to of 9523
 
Merck 'Optimistic' About Quick Regulatory Review of Vioxx

Bloomberg News
December 9, 1998, 2:13 p.m. ET

Merck 'Optimistic' About Quick Regulatory Review of Vioxx

Whitehouse Station, New Jersey, Dec. 9 (Bloomberg) -- Merck
& Co., the world's biggest drugmaker, said it is optimistic about
the changes of getting quick regulatory review of its
experimental painkiller Vioxx.

Merck also disclosed for the first time that Vioxx is
statistically no more likely to cause stomach ulcers than a
placebo, or sugar pill. That finding is important because Vioxx
is likely to be prescribed for long-term use in patients
suffering from arthritis, who risk developing ulcers when they
use existing painkillers.

Merck shares rose 11/16 to 159 3/8.

Merck told analysts that after three months, 7.3 percent of
patients on placebo had ulcers, compared to 4.7 percent of those
who received a 25 milligram daily dose of Vioxx and 8.1 percent
of those who received 50 milligrams. By comparison, 28.5 percent
of those treated with the painkiller ibuprofen developed ulcers.

Merck presented the research on Vioxx at its analyst meeting
in Whitehouse Station, New Jersey.

Edward Scolnick, president of Merck's research laboratories,
also said he was ''optimistic'' that the U.S. Food and Drug
Administration would grant Merck expedited review of Vioxx.

Merck submitted its U.S. Food and Drug Administration
application for Vioxx in November. Merck is looking to Vioxx to
offset the expected loss of patent by 2001 on four drugs with
combined 1997 sales of $3.5 billion.

Rival Monsanto Co.'s Celebrex is expected to be the first of
a new class of painkillers, the Cox-2 drugs. These appear to
treat pain and swelling without the side effects of existing
painkillers, which can cause stomach bleeding. Vioxx and Celebrex
are each expected to have annual sales of more than $1 billion.

If Merck wins accelerated review of Vioxx, it could be
introduced about six months after Celebrex. If not, it could
follow by about a year.

--Kerry Dooley in Whitehouse Station through the Washington

news.com



To: BigKNY3 who wrote (6453)12/9/1998 3:13:00 PM
From: Anthony Wong  Respond to of 9523
 
Merck to Add 700 Sales Reps, Seek Expanded Zocor Use (Update2)

Bloomberg News
December 9, 1998, 12:42 p.m. ET

Merck to Add 700 Sales Reps, Seek Expanded Zocor Use (Update2)

(Adds that Merck will present this afternoon on research
programs in 7th through 9th paragraphs, comment from chairman in
9th and 10th paragraphs. )

Whitehouse Station, New Jersey, Dec. 9 (Bloomberg) -- Merck
& Co., the world's biggest drugmaker, said it will add about 700
new sales representatives in the U.S. next year, expanding its
current sales force of about 4,000 by 17.5 percent.

The maker of the cholesterol-reducer Zocor and anti-baldness
pill Propecia reviewed other steps it is taking to boosts its
sales at an analysts' meeting. Merck also is seeking to add new
benefits to the label for Zocor, its top-selling product with
more than $3 billion in 1997 sales.

Merck has been facing increased competition for Zocor sales
in the past year from Warner-Lambert Co.'s similar drug Lipitor,
which Pfizer Inc. helps market. Merck said it is seeking U.S.
Food and Drug Administration approval to cite Zocor's ability to
boost levels of HDL, the ''good cholesterol,'' in some patients.

''Pfizer and Warner-Lambert are formidable competitors,''
said Viren Mehta, an analyst with Mehta Partners, which has a
''buy'' rating on Merck. ''Merck is going to use every
opportunity it can'' to try to boost Zocor sales.

Merck said its mid-October filing was based on studies in
which HDL rose about 13 percent to 16 percent for certain Zocor
patients. Zocor sales rose 10 percent to $990 million while sales
of Lipitor, introduced in 1997, more than doubled to $569
million.

Merck rose 5/16 to 159 in midday trading. The company,
based in Whitehouse Station, New Jersey, earlier touched a record
high of 160 1/4.

Later this afternoon, Edward Scolnick, president of Merck
Research Laboratories, will give an update on the company's next
potential blockbuster, the painkiller Vioxx. He also will speak
on some of Merck's current projects in development. Scolnick
leads a research program often considered the best in the drug
industry.

Still, rival Monsanto Co. could win FDA approval within a
month of a painkiller, Celebrex, similar to Merck's Vioxx.
Merck is at least several months behind Monsanto in the race to
introduce the first of a new class of painkillers, the Cox-2
drugs. These appear to treat pain and swelling without the side
effects of existing painkillers, which can cause stomach
bleeding. Vioxx and Celebrex are each expected to have annual
sales of more than $1 billion.

Vioxx ''will be an important contributor'' to boosting
Merck's profit, said the company' chief executive, president and
chairman, Raymond Gilmartin, in comments this morning at the
meeting.

''We strive for long-term earnings-per-share growth in the
top quartile of our peer group, which is made up of 12 large-cap,
multinational pharmaceutical companies such as Pfizer, Lilly and
Glaxo Wellcome,'' Gilmartin said.

Gilmartin did not comment directly on analysts' estimates in
his speech. Chief executives often do address how ''comfortable''
they are with current estimates of how much profit their
companies will earn at these kinds of meetings. Gilmartin will
speak again later today.

--Kerry Dooley in Whitehouse Station through the Washington

news.com



To: BigKNY3 who wrote (6453)12/9/1998 4:25:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 9523
 
NDA for Vioxx submitted to FDA on Nov. 23..around 6 months behind Celebrex, even if Vioxx is given priority review status.

Excerpt from Merck's new release:

The company also revealed new data on VIOXX™ (rofecoxib) -- its once- daily, anti-inflammatory COX-2-specific inhibitor for the treatment of the signs and symptoms of osteoarthritis and the relief of pain -- and confirmed it had submitted a New Drug Application to the U.S. Food and Drug Administration on November 23. Merck expects to have filed similar regulatory applications worldwide by the end of the year.

News Release - New Products to Drive Revenue and Earnings Growth, Merck Tells Analysts; New Data Released on Investigational Medicine for Osteoarthritis and Pain
biz.yahoo.com



To: BigKNY3 who wrote (6453)12/9/1998 5:14:00 PM
From: Anthony Wong  Respond to of 9523
 
Merck Guides Analysts to Lower Estimates, Shares Fall (Update1)

Bloomberg News
December 9, 1998, 4:36 p.m. ET

Merck Guides Analysts to Lower Estimates, Shares Fall (Update1)

(Updates markets, adds analyst comment)

Whitehouse Station, New Jersey, Dec. 9 (Bloomberg) -- Merck
& Co., the world's biggest drugmaker, guided analysts to lower
estimates for its profit in 1999 as it hires new sales people
and prepares to introduce its most important new drug.

Merck Chairman and Chief Executive Raymond Gilmartin said
the company could have per-share profit of $4.27 to $4.34 in 1998
and $4.85 to $4.95 in 1999.

Gilmartin's remarks at the company's annual meeting with
analysts meeting at its headquarters in Whitehouse Station, New
Jersey, sent shares down because the figures he gave are at the
lower end of the range of analysts' estimates.

Merck had been expected to earn $4.30 a share in 1998 and
$4.97 a share in 1999, the average estimates of analysts polled
by First Call Corp.

Merck fell 6 7/16 to close at 152 1/4. Earlier in the day,
Merck touched an all time high of 161 3/4.

Overall, investors were disappointed that Merck didn't have
any dramatic good news to announce at the analysts meeting, as it
has in past years, said Jeffrey J. Kraws, an analyst with Everen
Securities with an ''outperform'' rating on Merck.

''There was a lot of pent-up demand,'' he said.

Expanded Sales Force

Earlier, Merck said it will add about 700 new sales
representatives in the U.S. next year, expanding its current
sales force of about 4,000 by 17.5 percent.

Merck, the maker of the cholesterol reducer Zocor and the
AIDS pill Crixivan, said about 600 of the new sales
representatives will target primary care physicians.

The company also said it's seeking U.S. Food and Drug
Administration permission to include information on its Zocor
drug's label about how it may help boost levels of HDL, the so-
called ''good cholesterol.''

The move shows Merck is working hard to compete against
Warner-Lambert Co.'s cholesterol-reducing drug Lipitor, said
Viren Mehta, an analyst with Mehta Partners, which has a ''buy''
on Merck.

Merck also said it is optimistic about the chances of
getting quick regulatory review of its experimental arthritis
medicine Vioxx.

If Merck wins accelerated review at the U.S. Food and Drug
Administration, Vioxx could be introduced about six months after
Celebrex. If not, it could follow by about a year.

Merck disclosed for the first time a study that indicates
Vioxx is statistically no more likely to cause stomach ulcers
than a placebo, or a sugar pill. That finding is important
because Vioxx is likely to be prescribed for long-term use in
patients suffering from arthritis, who risk developing ulcers
when they use existing painkillers.

Marketplace Battle

Merck is lagging rival Monsanto Co. in what likely will
become ''one hell of a marketplace battle,'' said Anstice, who
leads Merck's U.S. drug sales. At an analyst meeting today, Merck
said its studies of Vioxx are more extensive than was the
research Monsanto has done on its similar drug, Celebrex.

Vioxx and Monsanto's Celebrex are both so-called Cox-2
drugs, which appear to treat pain and swelling without causing
irritating the stomach as existing painkillers do.

Merck told analysts today that after three months, 7.3
percent of patients on placebo had ulcers, compared to 4.7
percent of those who received a 25 milligram daily dose of Vioxx
and 8.1 percent of those who received 50 milligrams. By
comparison, 28.5 percent of those treated with the painkiller
ibuprofen developed ulcers.

Merck submitted its FDA application for Vioxx in November.
Merck is looking to Vioxx to offset the expected loss of patent
by 2001 on four drugs with combined 1997 sales of $3.5 billion.

Vioxx and Celebrex is expected to be the first of a new
class of painkillers, the Cox-2 drugs. These appear to treat pain
and swelling without the side effects of existing painkillers,
which can cause stomach bleeding. Vioxx and Celebrex are each
expected to have annual sales of more than $1 billion.

--Kerry Dooley in Whitehouse Station through the Washington

news.com