Here's the article I mentioned yesterday. Not as good as the title would indicate, but not bad:
California's Agouron Anticipates Approval of
Viracept HIV Treatment
Source: North County Times
North County Times via Knight-Ridder/Tribune via Individual Inc. : By Mario
C. Aguilera Knight-Ridder/Tribune Business News
LA JOLLA, Calif.--Feb. 22--Amazement, delight, euphoria.
Those are the emotions lately bounding through the halls of Agouron
Pharmaceuticals Inc., the La Jolla company on the brink of what no other
company in San Diego County's rich biotechnology industry has
accomplished: to guide a new drug from the development laboratory into the
public market.
Agouron's product to treat HIV infection, Viracept, is speeding along the
Food and Drug Administration's fast-tracking process for AIDS-related
products and could be approved within weeks, according to industry
observers.
Wall Street is expecting big things from Agouron, sending its stock from $15 a
share three years ago to an astonishing all-time high last week of $101. At the
same time, employment has zoomed from 238 to 530, quietly making
Agouron San Diego's largest biotech company.
If you've never heard of Agouron (pronounced AG-er-on), you're not alone.
Like many research-based biotechs, Agouron has never posted a profit. But
more important, co-founder and CEO Peter Johnson of Ramona and
communications director Donna Nichols of Encinitas have embraced a stealth
approach to publicity. "Underpromise and overperform" is their mantra.
"It's been our experience that managing expectations is so important," says
Johnson. "Particularly when you're dealing with diseases where there's a lot of
emotions associated -- with AIDS, with cancer -- the last thing somebody
needs is building unrealistic expectations or building expectations too early."
Other San Diego biotechs have come this far in the rigorous FDA drug
approval process only to fall flat.
In what remains a black eye in the history of local bioscience, flagship biotech
firm Gensia Inc. shocked the financial world in October 1994 when it
announced that its post-surgical heart drug Protara, which was cruising along
in development, did not significantly outperform a group treated with a
placebo in deep clinical studies.
The company never recovered, abandoned drug development and eventually
turned to manufacturing chemotherapy drugs for cancer. Gensia's common
stock crashed from a high of $42 a share in 1992 to under $5 today.
The Gensia saga remains a model of how a "sure-fire" bet in the speculative
world of biotechnology can jolt expectations.
For Agouron, the scenario appears to be playing out much differently.
Agouron began in 1984 with a handful of scientists hoping to apply a fresh
approach to some formidable afflictions of the human body: AIDS, cancer
and, later, the common cold.
"When we set out 13 years ago our goal was to bring great science to bear on
big problems," said Johnson. "And to have an impact."
Agouron's strategy was unique at the time and has since spun off similar
techniques in the drug discovery industry.
The first step in Agouron's "protein structure-based drug design" is identifying
a protein that plays a critical role in the disease. From there, researchers use
so-called "X-ray crystallography" to solve the exact structure of the protein.
"Then you have what we think of as a molecular block..." said Johnson. "Then
we begin to think of some ideas for some small molecule drug which will fit
into a crevice on this protein and shut it down."
When the FDA gives it the "Go" sign, Johnson said the company will begin
shipping tens of thousands of bottles of Viracept tablets, which are produced
in various locations and shipped out of Puerto Rico.
Agouron has invested more than $100 million into developing AG1343, the
product now known as Viracept.
Once it does hit the market, Viracept will become the fourth approved drug
that inhibits the HIV "protease," an enzyme that performs an essential role in
the infectious cycle of HIV, and the first drug expected to be cleared for
treating HIV-infected children.
But Agouron may have the edge over its competitors in some key areas.
Viracept is being seen as a potent ingredient in drug "cocktails," in which
patients ingest a mix of drugs rather than a single product.
Another plus for Viracept is that its major side effect, diarrhea, appears to be
managed better than other drugs' drawbacks, such as nausea.
And in the most recent development, Viracept was shown to be less resistant
to other protease drugs, making it a good choice in a new approach to HIV
treatment in which two protease drugs are used at once.
"That's why the stock has been so high in the last six months," said Jim
McCamant, editor of the Medical Technology Stock Letter.
"The market becomes twice as large when it looks like Viracept can be paired
with other drugs."
Merck & Co. Inc. sells its Crixivan protease drug for $4,800 to $5,200 per
year, while Abbott Laboratories sells Norvir for $7,500 to $8,000; and
Roche Holding's Invirase sells for about $7,200 a year.
For Agouron, which will set its price for Viracept upon approval, the market
potential is enormous.
Analysts have predicted Viracept's share of the billion-dollar worldwide HIV
market will be anywhere from $200 million to $600 million per year.
For the local economy, Agouron's success could translate into another 200 to
300 new jobs as it develops other new drugs.
Next in the pipeline is a drug called Thymitaq to treat head, neck and liver
cancer. Pivotal trials are being conducted in the U.S., Europe and Asia.
Further up the line is Agouron's drug designed to tackle the scientific enigma
known as the common cold.
"Most of us think of the cold as a minor annoyance," said Johnson. "But there
are 20 million people who have underlying lung diseases and are at risk for
complications, so it's actually a pretty serious infection."
Johnson said the family of "Rhino" viruses associated with the common cold
have a protease that plays the same function as one in the HIV structure.
Johnson believes that drug could move out of the labs and into development
as soon as next year.
But for now, the amazement, delight and euphoria at Agouron's La Jolla
headquarters focus on a drug called Viracept and the promise it holds for
putting San Diego on the biotechnology map, and more important, the way
HIV and AIDS are treated.
"It's not appropriate to call drugs like these cures, and there aren't any real
cures on the radar scope," says Johnson. "What Viracept does represent is
one widely used drug in combination therapy, which offers excellent prospects
for patients to manage HIV long term... For many patients who can resume
normal lives it represents not only the lifting of the death sentence that has
been associated with AIDS -- it's kind of a ticket to resume their life."
(c) 1997, North County Times, Escondido, Calif. Distributed by
Knight-Ridder/Tribune Business News.
AGPH,
[02-22-97 at 12:00 EST, Copyright 1997, Knight-Ridder/Tribune Business
News]
Contact: North County Times |
