Like coals to Newcastle.... This will be in Monday's IBD, and should be got for a pop or two:
MIXING IT UP Agouron May Soon Add Drug To AIDS 'Cocktail'
Arsenal
Date: 1/6/97
Author: Laura B. Benko
Agouron Pharmaceuticals Inc. knows there's more than one way to mix a cocktail.
That's why it's banking on its first drug, called Viracept, to make a splash among anti-AIDS combinations already
on the market.
The company filed for Food and Drug Administration approval of Viracept last week, more than a month earlier
than most analysts expected. If approved, it would become the 10th AIDS drug sold in the U.S.
HIV, the virus that causes AIDS, is best treated with a ''cocktail'' of three drugs. The need for more options is
great because some drugs don't work well with each other. Patients also can build up a resistance to one or more
of the drugs, rendering even good combinations ineffective, said Peter Johnson, Agouron's president and CEO.
''It's essential to have a number of candidates because even in combination, the usefulness of these drugs . . . is
often finite in nature. After time, patients need to change the components in order to maintain efficacy,'' Johnson
said. ''That's why having an arsenal of drugs available is a big advantage.''
Agouron is seeking an ''accelerated review'' of Viracept in tablet form for adults and in powder form for children.
The FDA often grants speedy approval for drugs that treat life-threatening diseases, provided that the drug maker
submit more data later. In March, the agency approved Merck & Co.'s Crixivan, which belongs to the same drug
class as Viracept, in a record 42 days.
If all goes well, Viracept could hit the market by the second quarter of 1997, analysts say. PaineWebber analyst
Douglas Lind expects the drug to garner more than $250 million in annual sales within three years.
Viracept is among a new class of powerful drugs called protease inhibitors, which work by blocking the protease
enzyme that the HIV virus needs to make copies of itself. So far, only Hoffmann-La Roche Inc., Abbott
Laboratories and Merck have had protease inhibitors approved.
When used with other types of AIDS drugs - namely, reverse transcriptase inhibitors, such as AZT and 3TC -
protease inhibitors can cut the amount of virus in a patient's blood to undetectable levels, research shows.
Viracept, developed jointly with the drug unit of Japan Tobacco Inc., has been tested on 1,800 patients through
various programs, Johnson said. Agouron plans to announce final test results at an AIDS conference in
Washington late this month.
Early data suggest that Viracept cuts HIV in the body to undetectable levels and boosts patients' immune-cell
counts, slowing down the onset of AIDS. What really makes the drug competitive, though, is its lack of severe
side effects, says Montgomery Securities analyst David Crossen.
''When the data comes out next month, I think we'll see Viracept has the best side-effect profile'' among all AIDS
drugs, Crossen said. ''Its only real side effect is diarrhea, which can be treated with standard (over-the-counter)
drugs.''
Side effects of other AIDS drugs range from nausea, vomiting and rash to kidney stones and facial numbness.
Viracept is also being tested as part of a new treatment approach - using two protease inhibitors together.
Agouron teamed up with Roche this month to study Viracept in combination with Roche's protease inhibitor,
Invirase.
Double protease-inhibitor therapy could offer patients ''more antiviral punch and a more livable safety and
side-effect profile'' than standard triple-drug therapy, Johnson said.
Already, early data look promising. A similar study conducted by Roche and Abbott showed that in patients who
took Invirase and Abbott's protease inhibitor, Norvir, HIV levels dropped by 99.9% and stayed low.
''It's very encouraging. But the real question - the question of duration - still has to be answered. That is, how long
will these drugs continue to work effectively together?'' Johnson said.
Bear, Stearns & Co. analyst David Molowa expects U.S. sales of AIDS drugs to double to $1 billion this year as
more patients begin to seek treatment.
The prospects for profit have got investors jumping. Agouron's market value has climbed more than tenfold to
$915 million since 1994, although the company has yet to turn a profit. The company also has three cancer drugs
in development.
For the fiscal first quarter ended Sept. 30, Agouron reported a net loss of $14.5 million, or $1.15 a share,
compared to a net loss of $2.5 million, or 33 cents, in the same period a year ago. Contract revenues rose 60%
to $17.5 million from $11 million. The stock, priced near 68, trades by AGPH. |
