Agouron Plans to Give Away
AIDS Drug to Some People
By RHONDA L. RUNDLE
Staff Reporter of THE WALL STREET JOURNAL
Agouron Pharmaceuticals Inc. plans to announce
Monday a program to give away its experimental
AIDS drug, Viracept, to people in an advanced
stage of the disease who have exhausted
treatments with similar drugs.
Viracept is a member of a family of
protease-inhibitor drugs that, when used in
combination with some older drugs, can make the
virus undetectable in the blood of some patients.
Viracept will be offered to people who have
stopped using the three commercially available
protease inhibitors because of adverse reactions,
intolerable side effects or, in a very small number
of cases, because the other drugs appear to be
losing their fight against the human
immunodeficiency virus.
Peter Johnson, president and chief executive
officer of the San Diego drug company, estimated
that "somewhere between several hundred to
probably several thousand patients" will be
candidates to receive Viracept free of charge. The
program will be unveiled in New Orleans at the
Conference on Antimicrobial Agents and
Chemotherapy.
'Expanded-Access' Program
The drug hasn't yet been approved by the U.S.
Food and Drug Administration but will be given
away with the FDA's approval under an
"expanded-access" program. The program ends
once the drug is approved for sale, but Agouron
says patients in the program won't be cut off if they
don't have insurance or funds to pay for the drug.
Agouron is following in the footsteps of
Hoffmann-La Roche Inc., Merck & Co., and Abbott
Laboratories Inc., which all set up
expanded-access programs to give their
respective protease inhibitors to certain patients
before the drugs received FDA approval. But
Viracept and several other emerging protease
inhibitors are being tested in a new era when rival
drugs are already on the market.
"Agouron has to answer a whole new set of
questions, because it is the first of an entire
second generation of up and coming
compounds," said Dawn Averitt, executive
director of the Women's Information Service and
Exchange, an Atlanta-based AIDS-treatment
group. The people who are waiting for Viracept
have tried the other drugs and can't take them or
are starting to see their virus levels climb, she
said.
Agouron expects to file its Viracept application
with the FDA early next year, and activists hope
the agency will move quickly to approve the drug.
The company has talked to other drug companies,
including Bristol-Myers Squibb Co., about a
possible marketing partnership. But Mr. Johnson
said, "it is now quite unlikely that we would have a
partner involved for the U.S. launch." However,
"we expect to have one or more partners" in the
European market, he added. Viracept would be
Agouron's first commercial product.
Overshadowed by Others
Viracept has been overshadowed by the three
protease inhibitors launched in December and
early this year. The giveaway program will draw
attention to Viracept, increase doctors' familiarity
with it, and identify patients who have been
unsuccessful in using the other protease inhibitors.
Mr. Johnson said these considerations were
"secondary" to the aim of responding to patients'
needs.
Agouron initially will limit eligibility to patients with
very weak immune systems as measured by CD4
white-cell counts of 50 or less. The drug will be
distributed starting Oct. 1 on a first-come,
first-serve basis. Agouron said it can treat at least
500 people at first and will scale up as needed.
Patients and doctors seeking information about
the program can call 1-800-621-7111.
In clinical tests of more than 600 people so far,
Viracept has proven to be at least as potent
against the virus as the approved drugs, Mr.
Johnson said. The only side effect appears to be
mild to moderate diarrhea.
"People like it, they don't feel bad on it, and it
seems to have good [antiviral] activity," said
Robert Schooley, head of the infectious-disease
division at the University of Colorado.
A burning question facing Viracept is whether it
will work in HIV-infected patients whose virus has
mutated in ways that resist the approved protease
inhibitors. Activists and physicians report that
some patients have "failed" all three drugs,
although scientific proof is rare. Mr. Johnson said
he believes there are "very, very few" people in
that situation. |
