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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?


To: Izzy who wrote (5345)9/18/1998 11:59:00 PM
From: Steve Fancy  Respond to of 6136
 
DuPont says AIDS drug to simplify treatment

Reuters, Friday, September 18, 1998 at 18:02

(adds details, quotes, analysis; previous Wilmington, Del)
By Ransdell Pierson
NEW YORK, Sept 18 (Reuters) - DuPont Pharmaceuticals (NYSE:DD)
said Friday it had won U.S. marketing approval for Sustiva, the
first once-a-day drug to treat the virus that causes AIDS,
predicting it would transform and simplify HIV treatment.
Sustiva, a so-called non-nucleoside reverse transcriptase
inhibitor, was approved late Thursday after a fast-track review
by the U.S. Food and Drug Administration.
The medication can be used with or without a protease
inhibitor -- drugs of another class that in recent years have
also helped reduce HIV infection and AIDS from a certain death
sentence to a chronic condition. Protease inhibitors are a
component of most anti-HIV cocktails.
The unit of DuPont Co. said patients should take three 200
milligram Sustiva (efavirenz) pills together at any time of the
day, with or without food, in two-drug, three-drug, or
four-drug combinations.
The 11 other anti-HIV drugs sold in the United States must
be taken at multiple times during the day, typically in
three-drug combos. Confusing dosing requirements create
lifestyle difficulties that have caused some patients to
abandon therapy.
"Typical patients are now taking 15 to 25 pills a day on
regimens that are hard to adhere to. Their entire lives revolve
around complicated schedules of taking a pill, maybe waiting
two hours to eat, and then taking another pill," DuPont
Pharmaceuticals president Nicholas Teti told Reuters.
"Sustiva will help patients live more normal lives," Teti
said, adding it was shown in studies of up to 24 weeks to
reduce HIV levels below detectable amounts. Long-term
effectiveness has not yet been demonstrated.
DuPont said side effects included nervous system problems
such as dizziness, insomnia, impaired concentration and
abnormal dreaming that generally lasted only for the first few
weeks of treatment.
The prescription drug will be priced at about $10.95 a day,
or $3,942 a year, which DuPont described as the "mid-range" of
anti-HIV medications.
ABN-AMRO Securities analyst Mario Corso said Sustiva could
become a leading anti-HIV drug because of its combination of
potency, safety and easy dosing, garnering potential annual
sales of $1 billion within five years,
"In the United States, only 50 percent of people who have
tested positive for the HIV virus are on drug therapy and a big
reason is that existing regimens are just too cumbersome,"
Corso said.
Protease inhibitors are particularly unwieldy. It is not
unusual for patients to take them at three intervals each day,
five pills at a time, Corso said.
By using Sustiva in combination only with reverse
transcriptase inhibitors, Corso said the total number of pills
taken by eligible patients could thereby be reduced to a
minimum, without sacrificing efficacy.
Moreover, Corso said protease inhibitors, which include
Merck & Co.'s (NYSE:MRK) Crixivan (indinivir) and Agouron
Pharmaceuticals Inc.'s (NASDAQ:AGPH) Viracept (nelfinivir), cause
more serious side effects than reverse transcriptase inhibitors
-- including nausea, diarrhea and unattractive fat deposits.
People who discontinue treatment with any HIV drugs can
allow the virus to mutate, rendering patients unresponsive in
the future not only to drugs they had been taking but to
chemically similar anti-HIV drugs.
The current standard of treatment is a three-drug cocktail
consisting of one protease inhibitor and two reverse
transcriptase inhibitors.
Reverse transcriptase inhibitors include two types, the
non-nucleoside variety and the more-common nuceloside variety
which includes Glaxo Wellcome Plc.'s (ISEL:GLXO) Epivir
(lamivudine), also known as 3TC.
Protease inhibitors and reverse transcriptase inhibitors
interfere at different sites of an enzyme vital for replication
of the HIV virus.
DuPont on July 1 secured marketing rights to Sustiva in the
United States, Canada and several European countries when it
bought for $2.6 billion Merck's interest in their former 50-50
joint venture, DuPont Merck Pharmaceutical Co.

Copyright 1998, Reuters News Service



To: Izzy who wrote (5345)9/19/1998 11:07:00 AM
From: Oliver & Co  Read Replies (1) | Respond to of 6136
 
Hi, Izzy.
I agree with you that the first choice in using PI's, is definitely Viracept, however, there is a place for the other PI's when Viracept either fails, or is not tolerated.
I can tell you that I am presently starting new patients in combos without PI's, eg: combivir+Viramune. And when it fails I go to Zerit, Videx and Viracept.
By the way I dumped all the stock yesterday, took my losses, but expect to pick it up again if it falls. Which I expect will happen next week. Then I will start day trading the stock (rolling it). Which is what I should have done a long time ago. You can not get emotionally involved in these things. There are too many playing it for money.

Hope you are doing well.

JLL



To: Izzy who wrote (5345)9/21/1998 5:51:00 PM
From: Elmer  Read Replies (2) | Respond to of 6136
 
Hi Izzy,
GLX plans to make the VRTX PI available on an early access program. Does that mean that a NDA is still some time off? Would they do that if it weren't effective?

Thanks
Dave