[AIDS Medicines in Development]

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IDRUGS AND VACCINES
Presented by the Pharmaceutical Manufacturers Association
In cooperation with the American Foundation for AIDS Research
and the Food and Drug Administration

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Summer 1990

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Since last winter, the
number of medicines and
combination therapies in
development for AIDS and related
disorders has risen to 77 from 71,
according to the latest survey by
the Pharmaceutical Manufacturers
Association. These 77 research
projects involve 62 medicines and
vaccines being developed by 40
companies.
Zovirax, by Burroughs Wellcome,
has received marketing approval
from the Food and Drug Administration for the treatment of herpes
zoster/simplex, a common opportunistic viral infection in AIDS
patients. Zovirax brings the total
number of approved medicines for
AIDS patients to 11. In addition,
Retrovir (AZT)-also by Burroughs
Wellcome and the only approved
drug to treat ARC and AIDS itselfhas been granted FDA approval for
treating HIV-positive asymptomatic
and symptomatic pediatric and
adult patients.
Investigation continues into the
use of combination drug therapy
for the treatment of AIDS and its
related illnesses. There are now 24
combination drug trials listed on
our survey, including 18 with
Retrovir-a doubling of both in the
past year and a half.
Opportunistic infections (Ols),
which account for up to 90 percent of AIDS-related deaths, are a
top priority for the research-based
pharmaceutical industry, according
to survey results. Of the 10 medicines added to the survey this
period, 8 are being tested for the

prevention or treatment of various
Ols. The continuing search for
new and improved OI therapies is
focusing on three important objectives: lowering toxicity; increasing
convenience through the development of alternatives to intravenous
administration; and overcoming
infectious organisms' resistance to
standard therapy.
Our survey's findings also include
the following:
* Antivirals. In development are
27 antivirals; 8 are combinations
of drugs-twice as many as last
winter. The medicines added to
this category since our last survey
are: FIAU by Oclassen Pharmaceutical in testing for HIV, ARC, AIDS,
and herpes group virus infections;
foscarnet sodium by Astra Pharmaceutical for CMV retinitis; and
MSL-109 by Sandoz for CMV infections and AIDS.
* Cytokines. In testing are 16
cytokines; 11 are combination
trials. The two medicines added to
this category are: alpha interferon
(low-dose oral) by Interferon
Sciences for ARC, and Proleukin
with Retrovir by Cetus for ARC
and AIDS.
* Immunomodulators. Being
tested are 10 immunomodulators;
2 are combinations.
* Anti-infectives. In development
are 19 anti-infectives, including
3 combination trials. The 5 additions to this category are: ABCD
by Liposome Technology for the
prevention of PCP (Pneumocystis
carinii pneumonia); Septra by
Burroughs Wellcome, also for PCP

prophylaxis; ABLC by Liposome
Company for treatment of cryptococcal meningitis and TLC-G-65
for MAI, a bacterial infection; and
SCH39304/42427 by ScheringPlough for treatment of opportunistic fungal infections and for
empirical treatment in neutropenic
sepsis.
* Vaccines. There are now 2
vaccines in human clinical trials by
2 companies.
* Other. In development are 3
medicines for other AIDS-related
problems, such as anorexia,
cachexia and diarrhea.
One application has been submitted to the FDA, and there are
now 14 medicines, or combinations
of them, in Phase III clinical trials,
5 more than last winter.
The progress in developing new
AIDS medicines, as shown in these
survey results, underscores the
need for a fair, efficient, and scientifically credible approval process
to make safe and effective drugs
available to treat patients in the
shortest possible time. To achieve
this objective, the pharmaceutical
industry must submit an adequate
body of data, and the FDA must
take the responsibility for positive
decisions, without requiring data
which are peripheral to the decision process.
Gerald J. Mossinghoff
President
Pharmaceutical Manufacturers Association