To combat the one of the world’s most devastatingdiseases, pharmaceutical and biotechnologyresearchers are testing 83 medicines for HIV/AIDS
and related conditions, intensifying their efforts and
achieving steady progress in the development of vaccines.
The medicines in the pipeline will add to the 80 that
have been approved since the virus that causes AIDS
was first identified just 20 years ago.
In what has been called “a silent revolution in AIDS
vaccine research,” 15 new vaccines are in development
and, according to the R&D database, Pharmaprojects,
62 projects were being evaluated earlier this year. Vaccine
research is considered crucial to control the AIDS pan-
demic. In September, it was announced that the first global
human tests of an experimental AIDS vaccine had begun in
18 cities in North America, South America, the Caribbean,
Southern Africa, and Southeast Asia. “I’m certainly more
optimistic than just a couple of years ago (about vaccine
research),” said Dr. Robert Gallo, who discovered the virus
that causes AIDS and is among those working to develop a
vaccine. “We can see the light at the end of the tunnel.”
AIDS has killed 28 million people and infected an
estimated 42 million people worldwide, 70 percent of
whom live in sub-Saharan Africa, where the pharmaceu-
tical industry is making special efforts to counter the
disease (see page 14). As many as 950,000 U.S. residents
are estimated to be living with HIV infection, though the
increased use of new medicines has helped to substan-
tially reduce the death rate from AIDS in this country in
recent years. By 2010, it’s estimated that 45 million new
people could be infected with the HIV virus—unless
there’s a dramatic breakthrough. “A safe and effective
HIV vaccine is critical to the control of HIV globally,”
says Dr. Anthony Fauci, Director of the National
Institute of Allergy and Infectious Disease.
In addition to the 15 vaccines, the medicines in devel-
opment, which are either in human clinical trials or are
at the Food and Drug Administration awaiting approval,
include 33 antivirals, 7 anti-infectives, 6 anti-cancer treat-
ments, 9 immunomodulators, 4 antifungals, and 13 other
types of drugs.
Of the medicines and vaccines in development, one
vaccine is designed to induce different types of immune
response, enhancing the overall immune response. The
first dose primes the body to induce cellular immunity.
The booster dose, consisting of genetically engineered
HIV subunits, induces neutralizing antibodies. Another
vaccine candidate is made from a noninfectious copy
of a protein from the surface of the AIDS virus. The
vaccine is designed to induce an immune response
through the production of antibodies that will prevent
the invading virus from attaching to a patient’s T-cells.
Examples of other AIDS medicines in the pipeline
include:
• A medicine that tries to block the integrase enzyme.
Existing drugs block one of two enzymes the HIV virus
need to reproduce, the reverse transcriptase and protease
enzymes. But HIV also needs an enzyme known as
integrase to make more copies of itself. This potential
new medicine would be the first to block that enzyme.
• An antisense gene therapy that uses two novel tech-
nologies to boost immune responsiveness against HIV.
One involves the insertion of a new type of genetic
material into blood cells to inhibit the growth of the
virus. The second involves inserting new genes into
target cells and integrating the gene into the chromo-
some of the cell. The cells containing the new genes
are then transferred to the patient.
While HIV/AIDS remains a formidable foe and world-
wide scourge, pharmaceutical and biotechnology companies
are meeting the challenge by continuing their all-out efforts
to develop novel and more effective therapies and vaccines
to contain the disease. They fully understand that patients
all over the world are depending on them.
Alan F. Holmer
President and CEO
PhRMA
2003
HIV/AIDS
M E D I C I N E S I N D E V E L O P M E N T F O R
Survey
P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L C O M P A N I E S
Researchers Are Testing 83 Medicines for HIV/AIDS;
Progress Being Made in Developing Vaccines
Vaccines
Immunomodulators
Antivirals
Antifungals
Anti-Infectives
4
7
33
9
15
Anticancers 6
13Others
2003 MEDICINES IN DEVELOPMENT FOR AIDS*
*Some medicines are l is ted in more than one category.
Medicines in Development for HIV/AIDS
A N T I C A N C E R S
Product Name Sponsor Indication Development Status*
A-007 Dekk-Tec AIDS-related Kaposi’s sarcoma Phase I
New Orleans, LA
Avastin™ National Cancer Institute AIDS-related Kaposi’s sarcoma Phase II
bevacizumab Bethesda, MD N C I T R I A L
Genentech (800) 4-CANCER
South San Francisco, CA
BMS 275291 Bristol-Myers Squibb AIDS-related Kaposi’s sarcoma Phase II
(MMPI) Princeton, NJ (212) 546-4000
halofuginone National Cancer Institute AIDS-related Kaposi’s sarcoma Phase II
Bethesda, MD N C I T R I A L
Collgard Biopharmaceuticals (800) 4-CANCER
Atlanta, GA
interleukin-12 National Cancer Institute AIDS-related Kaposi’s sarcoma Phase II
Bethesda, MD N C I T R I A L
(800) 4-CANCER
Rituxan™ National Cancer Institute HIV-associated lymphomas Phase II
rituximab Bethesda, MD N C I T R I A L
IDEC Pharmaceuticals (800) 4-CANCER
San Diego, CA
A N T I F U N G A L S
Product Name Sponsor Indication Development Status
0.5% C31G Biosyn oral infections associated with Phase I/II
oral rinse Philadelphia, PA immune suppression (215) 387-5338
DB 289 Immtech International Pneumocystis carinii pneumonia Phase II
Vernon Hills, IL (PCP) (847) 573-0033
(see also anti-infectives)
micafungin Fujisawa Healthcare invasive fungal infections application submitted
(FK463) Deerfield, IL (800) 727-7003
Noxafil Schering-Plough opportunistic fungal infections Phase III
posaconazole Kenilworth, NJ (908) 298-40000
A N T I - I N F E C T I V E S
Product Name Sponsor Indication Development Status
dapsone Jacobus Pharmaceutical Pneumocystis carinii pneumonia Phase III completed
Princeton, NJ (PCP) prophylaxis (609) 921-7447
dapsone and Jacobus Pharmaceutical PCP and toxoplasmosis Phase III completed
pyrimethamine Princeton, NJ prophylaxis (609) 921-7447
and folinic acid
dapsone with Jacobus Pharmaceutical PCP treatment Phase III completed
trimethoprim Princeton, NJ (609) 921-7447
2 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
* For more information about a specific medicine in this report, please call the telephone number listed.
A N T I - I N F E C T I V E S
Product Name Sponsor Indication Development Status
DB 289 Immtech International PCP Phase II
Vernon Hills, IL (see also antifungals) (847) 573-0033
GEM® 92 Hybridon HIV infection Phase I
Cambridge, MA (617) 679-5593
SPD705 Shire Pharmaceutical opportunistic infections Phase I
Development (240) 453-6400
Rockville, MD
Ushercell Polydex Pharmaceuticals prevention of HIV infection and Phase I/II
Toronto, Ontario other sexually transmitted diseases (416) 755-2231
A N T I V I R A L S
Product Name Sponsor Indication Development Status
640385 GlaxoSmithKline HIV infection Phase I
(VX-385) Philadelphia, PA (888) 825-5249
(aspartyl protease Rsch. Triangle Park, NC
inhibitor) Vertex Pharmaceuticals
Cambridge, MA
678248 GlaxoSmithKline HIV infection Phase I
(NNRTI) Philadelphia, PA (888) 825-5249
Rsch. Triangle Park, NC
695634 GlaxoSmithKline HIV infection Phase I
(NNRTI) Philadelphia, PA (888) 825-5249
Rsch. Triangle Park, NC
810781 GlaxoSmithKline HIV infection Phase II
(integrase Philadelphia, PA (888) 825-5249
inhibitor) Rsch. Triangle Park, NC (973) 966-6900
873140 GlaxoSmithKline HIV infection Phase I
(ONO-4128) Philadelphia, PA (888) 825-5249
(CCR5 antagonist) Rsch. Triangle Park, NC
AG-1859 Pfizer HIV positive Phase I
New York, NY (860) 732-6058
Alferon N Hemispherx Biopharma HIV infection Phase III
Injection® New Brunswick, NJ (888) 728-4372
interferon alfa-n3 --------------------------------------------------------------------------------------
HIV & hepatitis C co-infection Phase II
(see also immunomodulators) (888) 728-4372
AMD070 AnorMed HIV infection treatment Phase I
Vancouver, BC (604) 530-1057
amdoxovir Gilead Sciences HIV disease treatment Phase II
(DAPD) Foster City, CA (650) 574-3000
(purine nucleoside
analog)
Anticort™ Samaritan Pharmaceuticals HIV infection Phase II completed
procaine HCl Las Vegas, NV (702) 735-7001
3M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
A N T I V I R A L S
Product Name Sponsor Indication Development Status
Beta-L-Fd4C Achillion Pharmaceuticals HIV infection Phase II
West Haven, CT (203) 624-7000
calanolide A Sarawak MediChem HIV infection Phase II
(NNRTI) Pharmaceuticals and (630) 739-6744
Advanced Life Sciences
Woodbridge, IL
capravirine Pfizer HIV infection/AIDS Phase II
(NNRTI) New York, NY (860) 732-6058
CCR5 receptor Schering-Plough HIV infection Phase I
antagonist Kenilworth, NJ (908) 298-4000
entecavir Bristol-Myers Squibb HIV & hepatitis B co-infection Phase III
(BMS 200475) Princeton, NJ (212) 546-4000
Epivir® GlaxoSmithKline HIV infection Phase III
lamivudine Philadelphia, PA (888) 825-5249
Ziagen® Rsch. Triangle Park, NC
abacavir
(combination tablet)
GS 7340 Gilead Sciences HIV infection/AIDS Phase I
Foster City, CA (650) 574-3000
IFN-alpha lozenge Amarillo Biosciences treatment of oral warts in Phase III
(natural human Amarillo, TX HIV-seropositive patients (806) 376-1741, ext. 22
interferon-alpha) (see also immunomodulators)
(Orphan Drug)
ME-609 Medivir oral herpes Phase I
Huddinge, Sweden 46-8-608-3100
MIV-310 Medivir multi-resistant HIV infection Phase II
Huddinge, Sweden 46-8-608-3100
Multikine® CEL-SCI HIV/human papillomavirus Phase I
leukocyte Vienna, VA co-infection in women with (703) 506-9460
interleukin cervical dysplasia
injection (see also immunomodulators)
PCL-016 Novactyl herpes labialis (cold sores), Phase II
St. Louis, MO herpes genitalis (genital herpes) (800) 654-2299
Upsher-Smith Laboratories
Maple Grove, MN
peptide T Avanced Immuni T HIV infection Phase II
Stony Brook, NY
PRO 542 Progenics Pharmaceuticals HIV infection Phase II
Tarrytown, NY (914) 789-2800
R724 Roche HIV infection Phase II
(T-1249) Nutley, NJ (973) 235-5000
(fusion inhibitor) Trimeris (919) 419-6050
Durham, NC
R944 Roche HIV disease Phase I
(PI) Nutley, NJ (973) 235-5000
4 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
A N T I V I R A L S
Product Name Sponsor Indication Development Status
SPD754 Shire Pharmaceutical HIV infection Phase II
Development (240) 453-6400
Rockville, MD
SPD756 Shire Pharmaceutical HIV infection Phase I
Development (240) 453-6400
Rockville, MD
tipranavir Boehringer Ingelheim HIV infection Phase III
(PI) Pharmaceuticals (203) 798-9988
Ridgefield, CT
TMC114 Tibotec HIV infection Phase I/II
(PI) Yardley, PA
TMC125 Tibotec HIV infection Phase II
(NNRTI) Yardley, PA
UK-427,857 Pfizer HIV positive Phase II
New York, NY (860) 732-6058
Viread® Gilead Sciences once-daily regimen for the treatment Phase III
tenofovir disoproxil Foster City, CA of HIV infection in combination (650) 574-3000
fumarate with Emtriva™ (lemtricabine) and
efavirenz versus a regimen with
Combivir® (lamivudine/zidovudine)
and efavirenz
I M M U N O M O D U L A T O R S
Product Name Sponsor Indication Development Status
Alferon N Hemispherx Biopharma HIV infection Phase III
Injection® New Brunswick, NJ (888) 728-4372
interferon alfa-n3 --------------------------------------------------------------------------------------
HIV & hepatitis C co-infection Phase II
(see also antivirals) (888) 728-4372
Ampligen® Hemispherx Biopharma HIV infection Phase II
Philadelphia, PA (salvage therapy) (215) 988-0080
--------------------------------------------------------------------------------------
HIV infection Phase II
(strategic treatment intervention) (215) 988-0080
BAY 50-4798 Bayer HIV infection Phase I
West Haven, CT (800) 468-0894
IFN-alpha lozenge Amarillo Biosciences treatment of oral warts in Phase III
(natural human Amarillo, TX HIV-seropositive patients (806) 376-1741, ext. 22
interferon-alpha) (see also antivirals)
(Orphan Drug)
IMMUNITIN™ Hollis-Eden HIV infection/AIDS Phase II
(HE2000) Pharmaceuticals (858) 587-9333
San Diego, CA
MDX-010 Medarex HIV infection Phase I
Princeton, NJ (908) 479-2400
5M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
I M M U N O M O D U L A T O R S
Product Name Sponsor Indication Development Status
Multikine® CEL-SCI HIV/human papillomavirus Phase I
leukocyte Vienna, VA co-infection in women with (703) 506-9460
interleukin cervical dysplasia
injection (see also antivirals)
SGN 00101 StressGen Biotechnologies genital warts Phase II
Victoria, British Columbia (800) 661-4978
WF10 Dimethaid Research late-stage HIV disease Phase III
Markham, Ontario (905) 415-1446
V A C C I N E S
Product Name Sponsor Indication Development Status
AG-702 Antigenics genital herpes Phase I
New York, NY (212) 332-4774
AIDS vaccine United Biomedical HIV infection Phase I
Hauppauge, NY (631) 273-2828
AIDSVAX® VaxGen HIV infection prophylaxis Phase III
Brisbane, CA (650) 624-1000
ALVAC™ Aventis Pasteur HIV infection prophylaxis and Phase II
(vCP1452) Swiftwater, PA immunotherapy (570) 839-4267
ALVAC™ Aventis Pasteur HIV infection prophylaxis and Phase III
(vCP1521) Swiftwater, PA immunotherapy (570) 839-4267
AVX101 AlphaVax HIV infection Phase I
(HIV vaccine) Rsch. Triangle Park, NC (919) 595-0400
EP HIV-1090 Epimmune HIV-1 therapy Phase I
San Diego, CA (858) 860-2515
genital herpes AuRx treatment of genital herpes Phase I/II completed
vaccine Glen Burnie, MD (410) 590-7610
HIVA.DNA-MVA International AIDS HIV-1 prophylaxis Phase I/II
Vaccine Initiative (212) 847-1111
New York, NY
HIV recombinant GlaxoSmithKline HIV prophylaxis Phase I
vaccine Philadelphia, PA (888) 825-5249
Rsch. Triangle Park, NC
HIV vaccine Emory Vaccine Center HIV infection Phase I
Atlanta, GA
GeoVax
Atlanta, GA
NIAID
Bethesda, MD
HIV vaccine Merck prevention and treatment of HIV Phase I
Whitehouse Station, NJ infection/AIDS (800) 672-6372
recombinant Therion Biologics AIDS Phase I
vaccine Cambridge, MA (617) 475-7253
Simplirix GlaxoSmithKline genital herpes prophylaxis Phase III
recombinant Philadelphia, PA (888) 825-5249
vaccine Rsch. Triangle Park, NC
6 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
V A C C I N E S
Product Name Sponsor Indication Development Status
tat toxoid Aventis Pasteur HIV infection prophylaxis and Phase I
Swiftwater, PA immunotherapy (570) 839-4267
O T H E R S
Product Name Sponsor Indication Development Status
1.0% C31G Biosyn prevention of HIV transmission and Phase II/III
vaginal gel Philadelphia, PA other sexually transmitted diseases (215) 387-5338
AVR118 Advanced Viral Research HIV infection Phase I/II
Yonkers, NY (914) 376-7383
buffer gel ReProtect prevention of sexual transmission Phase II
(microbicide) Baltimore, MD of HIV infection (410) 516-7260
HGTV43 Enzo Biochem HIV-1 infection Phase I/II
(gene medicine) Farmingdale, NY (631) 755-5500
HIV therapeutic United Biomedical block progression from Phase I
Hauppauge, NY HIV infection to AIDS (631) 273-2828
NEUPOGEN® Amgen treatment of neutropenia application submitted
filgrastim Thousand Oaks, CA in HIV-infected patients (805) 447-1000
(G-CSF)
NGX-4010 NeurogesX painful HIV-associated neuropathy Phase II/III
San Carlos, CA (650) 508-2116
PRO 2000 Indevus Pharmaceuticals prevention of HIV infection Phase II/III
Lexington, MA transmission (intravaginal gel) (781) 861-8444
prosaptide Savient Pharmaceuticals HIV-associated neuropathic pain Phase II
East Brunswick, NJ (800) 284-2480
rhlGF-1/rhlGFBP-3 Insmed AIDS lipodistrophy Phase II
Richmond, VA (804) 565-3000
Serostim™ Serono HIV-associated adipose Phase III
somatropin (rDNA Rockland, MA redistribution syndrome (800) 283-8088
origin) for injection
(Orphan Drug)
UC-781 Biosyn prevention of sexually-transmitted Phase I
(microbicide) Philadelphia, PA HIV (215) 387-5338
VRX496 VIRxSYS HIV infection Phase I
Gaithersburg, MD
The content of this survey has been obtained through government and industry sources based on the latest informa-
tion. Survey current as of November 7, 2003. The information may not be comprehensive. For more specific
information about a particular product, contact the individual company directly. The entire series of “Medicines
in Development” is available on PhRMA’s web site.
PhRMA Internet address: http://www.phrma.org
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
Copyright © 2003 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded
if proper credit is given.
7M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
A P P R O V E D M E D I C I N E S F O R H I V I N F E C T I O N / A I D S
Product Name Company Indication
Agenerase® GlaxoSmithKline HIV infection/AIDS
amprenavir Philadelphia, PA
(PI) Rsch. Triangle Park, NC
Vertex Pharmaceuticals
Cambridge, MA
Combivir® GlaxoSmithKline HIV infection
lamivudine/ Philadelphia, PA
zidovudine tablets Rsch. Triangle Park, NC
(NRTI)
Crixivan® Merck HIV infection
indinavir sulfate Whitehouse Station, NJ
(PI)
Emtriva™ Gilead Sciences treatment of HIV-1 infection in adults in combination with other
emtricitabine Foster City, CA antiretroviral medications
(NRTI)
Epivir® GlaxoSmithKline HIV infection, HIV infection (once-daily dosing)
lamivudine (3TC) Philadelphia, PA
(NRTI) Rsch. Triangle Park, NC
BioChem Pharma
Laval, Quebec
Fortovase® Roche treatment of HIV infection in adults in combination with
saquinavir Nutley, NJ other antiretroviral agents
mesylate (PI)
(soft gel
formulation)
Fuzeon® Roche HIV infection/AIDS
enfuvirtide Nutley, NJ
Trimeris
Durham, NC
Gamimune®-N Bayer pediatric HIV infection
immune globulin Berkeley, CA
intravenous
(human)
HIVID® Roche in combination with other antiviral agents for treatment of
zalcitabine Nutley, NJ HIV infection
(NRTI)
Invirase® Roche treatment of HIV infection in combination with other
saquinavir mesylate Nutley, NJ antiviral agents
(PI)
Kaletra® Abbott Laboratories treatment of HIV infection in adults and children
lopinavir/ritonavir Abbott Park, IL
(PI)
Lexiva™ GlaxoSmithKline treatment of HIV infection in combination with other
fosamprenavir Philadelphia, PA antiretroviral medications
calcium Rsch. Triangle Park, NC
(PI) Vertex Pharmaceuticals
Cambridge, MA
Norvir® Abbott Laboratories HIV infection (pediatric and adult)
ritonavir Abbott Park, IL
(PI)
8 M E D I C I N E S I N D E V E L O P M E N T F O R HIV/AIDS 2003
A P P R O V E D M E D I C I N E S F O R H I V I N F E C T I O N / A I D S
Product Name Company Indication
Rescriptor® Agouron Pharmaceuticals, HIV infection/AIDS
delvaridine a Pfizer Company
(NNRTI) La Jolla, CA
Retrovir® GlaxoSmithKline HIV positive (asymptomatic [CD4<500] and symptomatic
zidovudine (AZT) Philadelphia, PA [ARC, AIDS]), pediatric and adult, prevention of maternal/fetal
(NRTI) Rsch. Triangle Park, NC transmission of HIV infection
Reyataz™ Bristol-Myers Squibb treatment of HIV-1 infection in combination with other
atazanavir sulfate Princeton, NJ antiretroviral medications
(PI)
Sustiva® Bristol-Myers Squibb HIV infection
efavirenz Princeton, NJ
(NNRTI)
Sustiva® Bristol-Myers Squibb HIV infection
efavirenz Princeton, NJ
(once-daily)
(NNRTI)
Trizivir® GlaxoSmithKline HIV infection treatment
abacavir, Philadelphia, PA
lamivudine and Rsch. Triangle Park, NC
zidovudine
combination tablet
(NRTI)
VIDEX® Bristol-Myers Squibb HIV infection, pediatric HIV infection, once-daily dosing
didanosine (ddI) Princeton, NJ
(NRTI)
VIDEX® EC Bristol-Myers Squibb HIV infection
didanosine (ddI) Princeton, NJ
(NRTI)
Viracept® Agouron Pharmaceuticals, HIV infection/AIDS (pediatric and adult)
nelfinavir mesylate
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