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Therapy Profile
In our Therapy Profiles you can find wide-ranging background information on each
therapeutic classification adapted from EphMRA codes. They help subscribers to:
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Understand the classification better
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Provide statistical data on the diseases covered
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Get a quick overview of marketed and emerging products
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Identify issues likely to affect the market, and provide weblinks to sites containing
further background information
THERAPEUTIC DEFINITIONS | INCIDENCES AND MARKET VALUES | CURRENT THERAPY| TRENDS | MARKET DEVELOPMENTS| RELATED WEBSITES
ANTIVIRAL, ANTI-HIV (J5A)
see also: Immunostimulant, anti-AIDS (I1A); Antiviral, interferon (J5B); Antiviral
(J5Z); Prophylactic vaccine (J7A1); Therapeutic vaccine (J7A2); Recombinant vaccine
(T2B).
MARKET RATING: 2 (worldwide sales of US$501-2000 million per year)
THERAPEUTIC DEFINITIONS
The human immunodeficiency virus, or HIV, is a virus which attacks the immune
system, generally leading to Acquired Immunodeficiency Syndrome (AIDS). HIV is
a lentivirus, with a genome of RNA and a glycoprotein envelope. The envelope glycoprotein
gp120 can bind to receptors on human CD4 (T4) lymphocytes, cells which are normally
involved in defence against invading organisms. Once inside the cell, the virus
uses its own enzyme, reverse transcriptase, to make a DNA copy of its genome,
which can then insert into the host cell's genome. From here, a combination of
host and viral enzymes are used to make new virus particles which burst from the
cell, killing it. Syncitial formation can also occur.
Infection with HIV follows an unusual course. After the initial infection, an
acute phase is seen which lasts for only a few weeks. This is followed by seroconversion
and an asymptomatic phase. This stage commonly lasts for around ten years, during
which the patient may have no clinical signs of infection, and infection can only
be detected by the presence of antibodies to HIV or measurement of viral load
in the bloodstream. However, viral replication continues at a high level during
this 'latent' phase, and the virus and the immune system are involved in a titanic
struggle, which eventually wears the body's defences out. The blood viral load
is used as a measure of expected rate of progression of the disease. When it rises,
and CD4 cell depletion subsequently accelerates, clinical manifestations begin
or worsen. This usually occurs when CD4 cell levels fall below 200 cells/mm3.
Opportunistic infections and certain cancers may develop in such individuals.
These are usually the ultimate cause of death in AIDS patients. However, HIV itself
has some other direct clinical effects, particularly on the gastrointestinal and
neurological systems. Raised TNF levels in AIDS patients can also cause cachexia
(wasting). It is thought the course of the disease may be affected by host factors
and a number of other cofactors.
Two subspecies of HIV, HIV-1 and -2 have been identified, HIV-2 being more usually
found in Africa. Not all drugs act equipotently on HIV-1 and -2. The epidemiology
of opportunistic infections also varies, with tuberculosis re-emerging as a major
killer in Africa and poorer parts of developed countries. Other major causes of
AIDS-associated death include Pneumocystis carinii pneumonia, cytomegalovirus
infections, toxoplasmosis, Mycobacterium avium intracellulare, Kaposi's sarcoma
and lymphoma.
The virus mutates at a high level. Standard treatment in the developed world
is triple combination antiretroviral therapy, known as HAART, but treatment failure
due to resistance development is common. Anti-HIV drugs also have cumulative toxicities.
For these reasons, there is a requirement for an increasing range of antiretroviral
options, particularly drugs which act against targets other than reverse transcriptase
or the HIV protease. However, for the vast majority of those infected with HIV,
getting access to the minimum basic standard of anti-HIV drugs is beyond their
means, and there is major pressure on pharmaceutical companies and governments
to come up with solutions to prevent AIDS devastating the developing world. Some
progress has be made in recent years.
Updated by IL on 25/03/2004.
INCIDENCES AND MARKET VALUES
Infection, HIV/AIDS
|
DESCRIPTION |
AMOUNT |
AREA |
SOURCE |
| |
|
|
|
|
HIV infection 2005/ adult prevalence |
40.3 million/ 1.1% |
Worldwide |
UN AIDS epidemic update, Dec 2005 |
|
AIDS deaths, 2005 |
3.1 million |
Worldwide |
UN AIDS epidemic update, Dec 2005 |
|
New infections, 2005 |
4.9 million |
Worldwide |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
25.8million/ 7.2% |
Sub-Saharan Africa |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
7.4million/ 0.7% |
S & SE Asia |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
1.8million/ 0.6% |
Latin America |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
1.6million/ 0.9% |
E Europe and C Asia |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
0.87million/ 0.1% |
E Asia |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
1.2million/ 0.7% |
N America |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
0.72million/ 0.3% |
W & C Europe |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
0.51million/ 0.2% |
N Africa and Middle East |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
0.3million / 1.6% |
Caribbean |
UN AIDS epidemic update, Dec 2005 |
|
HIV infection/adult prevalence |
74,000/
0.5% |
Oceania |
UN AIDS epidemic update, Dec 2005 |
|
2002 salesHIV/AIDS therapies |
US 3.03 billion |
US |
Press release, Frost & Sullivan, 3 Feb 2003 |
|
2001 sales, antiretrovirals |
US $3.2 billion |
US |
IMS Health salesfigures |
|
2004 sales for antiretrovirals with sales of >200 million |
|
|
|
|
2003 salesTrizivir (lamivudine + zidovudine + abacavir) |
UK
pounds 376 million |
Worldwide |
Annual Report, GSK, 2003 |
|
2003 sales, Combivir (lamivudine + zidovudine) |
UK pounds 589 million |
Worldwide |
Annual Report, GSK, 2003 |
|
2003 sales Epivir
(lamivudine) |
UK
pounds 293 million |
Worldwide |
Annual Report, GSK, 2003 |
|
2003 sales, Ziagen (abacavir) |
UK
pounds 167 million |
Worldwide |
Annual Report, GSK, 2003 |
|
2003 sales Viracept (nelfinavir) |
CHF 276 million |
Worldwide |
Annual Report, Roche, 2003 |
|
2003 sales Zerit (stavudine) |
US $354 million |
Worlwide |
Annual Report, BMS 2003 |
|
2003 sales Viread (tenofovir disproxil fumarate) |
US $566 million |
Worldwide |
Press Release, Gilead,2 9 Jan 2004 |
|
2003 sales Sustiva/Stocrin (efavirenz) |
US $544 million |
Worldwide |
Annual Report, BMS, 2003 |
|
2001 sales Viramune (nevirapine) |
Euro 310 million |
Worldwide |
Co presentation, Boehringer Ingelheim, 30 Mar 2004 |
|
2003 sales Kaletra (lopinavir + ritonavir) |
US $752 million |
Worldwide |
Press release, Abbott, 16 Jan 2004 |
|
2003 sales Videx (didanosine) |
US $267 million |
Worldwide |
Annual Report, BMS, 2003 |
|
2003 sales Viread (tenofovir disoproxil fumarate) |
US $566 million |
Worldwide |
Press release, Gilead, 29 Jan 2004 |
Updated by IL on 0612/2004.
CURRENT THERAPY
|
DRUG NAME |
ORIGINATOR |
PHARMACOLOGY |
| |
|
|
|
nevirapine |
Boehringer Ingelheim |
PO-RDNA- |
|
stavudine |
Bristol-Myers Squibb |
PO-RDNA- |
|
didanosine |
NIH |
PO-RDNA- |
|
emtricitabine+tenofovir DF |
Gilead Sciences |
PO-RDNA- |
|
zalcitabine |
NIH |
PO-RDNA- |
|
delavirdine |
Pfizer |
PO-RDNA- |
| tenofovir disoproxil fumarate |
Gilead Sciences |
PO-RDNA- |
|
zidovudine |
GlaxoSmithKline |
PO-RDNA- |
|
abacavir+lamivudine, GSK |
3M Pharmaceuticals |
PO-RDNA- |
|
efavirenz |
Merck & Co |
PO-RDNA- |
|
lamivudine+zidovudine+abacavir |
GlaxoSmithKline |
PO-RDNA- |
|
lamivudine |
Shire |
PO-RDNA- |
|
lamivudine+zidovudine |
Shire |
PO-RDNA- |
|
emtricitabine |
Gilead Sciences |
PO-RDNA- |
|
abacavir sulfate |
GlaxoSmithKline |
PO-RDNA- |
|
nelfinavir mesylate |
Pfizer |
Pfizer |
|
ritonavir |
Abbott |
PR-H- |
|
saquinavir |
Hoffmann-La Roche |
PR-H- |
|
ritonavir, soft gel |
Abbott |
PR-H- |
|
indinavir sulfate |
Merck & Co |
PR-H- |
|
atazanavir sulfate |
Bristol-Myers Squibb |
PR-H- |
|
fosamprenavir calcium |
GlaxoSmithKline |
PR-H- |
|
lopinavir + ritonavir |
Abbott |
PR-H- |
|
amprenavir |
Vertex Pharmaceuticals |
PR-H- |
|
enfuvirtide |
Trimeris |
GP-41- |
|
didanosine, once daily |
Bristol-Myers Squibb |
PO-DRNA- |
TRENDS
|
DRUG NAME |
ORIGINATOR |
PHARMACOLOGY |
STATUS |
| |
|
|
|
|
tipranavir |
Pfizer |
PR-H- |
Registered |
|
darunavir |
Johnson & Johnson |
PR-H- |
Pre-registered |
|
etavirine |
Johnson & Johnson |
PO-RDNA- |
Phase III Clinical Trial |
|
MK-518 |
Merck & Co |
INT-HIV- |
Phase III Clinical Trial |
|
Ushercell |
Polydex |
UN |
Phase III Clinical Trial |
|
PRO-2000 |
Paligent |
GP-120- |
Phase III Clinical Trial |
|
carrageenan, PC |
Non-industrial source |
UN |
Phase III Clinical Trial |
|
efavirenz+emtricitabine+tenofo |
Gilead |
PO-RDNA- |
Phase III Clinical Trial |
|
glyminox gel |
Biosyn |
UN |
Phase III Clinical Trial |
| inteferon, Hemispherx |
Hemispherex Biopharma |
IF-A-N3+ |
Phase III Clinical Trial |
|
maraviroc |
Pfizer |
CK-CC-5- |
Phase III Clinical Trial |
|
FTC, racemic, Pharmasset |
Pharmasset |
PO-RDNA- |
Phase II Clinical Trial |
|
anti-HIV MAbs, Polymun |
Polymun |
IM+ |
Phase II Clinical Trial |
|
brecanavir |
Vertex Pharmaceuticals |
PR-H- |
Phase II Clinical Trial |
|
HGTV-43 |
Enzo Biochem |
PRT-TAT- |
Phase II Clinical Trial |
|
capravirine |
Shionogi |
PO-RDNA- |
Phase II Clinical Trial |
|
dexelvucitabine |
Pharmasset |
PO-RDNA- |
Phase II Clinical Trial |
|
PA-457 |
Panacos |
GAG-H |
Phase II Clinical Trial |
|
BI-201 |
BioInvent |
PRT-TAT |
Phase II Clinical Trial |
|
rilpivirine |
Johnson & Johnson |
PO-RDNA- |
Phase II Clinical Trial |
|
vicriviroc maleate |
Schering-Plough |
CK-CC-5- |
Phase II Clinical Trial |
|
c-1605 |
Merck & Co |
UN |
Phase II Clinical Trial |
|
JTK-303 |
Japan Tobacco |
INT-HIV |
Phase II Clinical Trial |
|
SPD-754 |
Shire |
PO-RDNA- |
Phase II Clinical Trial |
|
HDP-99.0002 |
Heidelberg Pharma |
PO-RDNA- |
Phase II Clinical Trial |
|
fozivudine tidoxil |
Heidelberg Pharma |
PO-RDNA- |
Phase II Clinical Trial |
|
semapimod |
Cytokine PharmaSciences |
KI-P38 |
Phase II Clinical Trial |
|
VRX-496 |
VIRxSYS |
GP-120- |
Phase II Clinical Trial |
|
GEM-92 |
Idera Pharmaceuticals |
GAG-H |
Phase II Clinical Trial |
|
TNX-355 |
Tanox |
CD-4- |
Phase II Clinical Trial |
|
(+)-calanolide A |
Advanced Life Sciences |
PO-RDNA- |
Phase II Clinical Trial |
|
GEM-92 |
Hybridon |
GAG-H- |
Phase II Clinical Trial |
|
AMD-070 |
AnorMED |
CK-CX-4- |
Phase II Clinical Trial |
|
mifepristone, VGX |
VGX Pharmaceuticals |
LIPCOR- |
Phase II Clinical Trial |
|
Anticort |
Samaritan Pharmaceuticals |
LIPCOR- |
Phase II Clinical Trial |
|
amdoxovir |
Non-industrial source |
PO-RDNA- |
Phase II Clinical Trial |
|
T-1249 |
Trimeris |
GP-141 |
Phase II Clinical Trial |
|
BlockAide/CR |
Adventrx |
GP-120- |
Phase II Clinical Trial |
|
dapivirine |
Johnson & Johnson |
PO-RDNA- |
Phase II Clinical Trial |
|
tenofovir |
Gilead Sciences |
PO-RDNA- |
Phase II Clinical Trial |
|
RPI-78M |
Nutra Pharma |
ACH- |
Phase II Clinical Trial |
|
elvucitabine |
Vion Pharmaceuticals |
PO-RDNA- |
Phase II Clinical Trial |
|
Ampligen |
Hemispherx Biopharma |
RIBO+ |
Phase II Clinical Trial |
|
AVR-118 |
Advanced Viral Research |
CK-CX-4- |
Phase II Clinical Trial |
| GW-695634 |
GlaxoSmithKline |
PO-RDNA- |
Phase II Clinical Trial |
Updated by IL on 07/04/2006.
PHARMACOLOGY KEY
|
PHARMACOLOGY |
DESCRIPTION |
| |
|
|
ACH- |
Acetylcholine antagonist |
|
CD-4- |
CD4 antagonist |
|
CK-CC-5- |
CC cemokine receptor 5 antagonist |
|
CK-CX-4- |
CXC chemokine receptor 4 antagonist |
|
GAG-H- |
HIV gag inhibitor |
|
GP-120- |
GP120env antagonist |
|
GP-41- |
gp41 antagonist |
|
IF-A-N3+ |
Interferon alpha N3 agonist |
|
KI-P38- |
P38 kinase inhibitor |
|
PO-DRNA- |
DNA directed RNA polymerase inhibitor |
|
PO-RDNA- |
RNA directed DNA polymerase inhibitor |
|
PR-H- |
HIV protease inhibitor |
|
PRT-TAT- |
Transactivator transcription protein inhibitor |
|
RIBO+ |
Ribonuclease stimulant |
|
UN |
Unidentified pharmacological activity |
| |
|
MARKET DEVELOPMENTS
|
EVENT |
SOURCE |
| |
|
|
Patents for first NRTIs begin to expire in 2005-6 |
SMi Conf HIV Ther (London), 2001 |
|
First generation protease inhibitors' patents begin to expire in 2010 |
Patent priority dates |
|
Sustiva is the only NNRTI to be 'strongly-recommended' for use in in 1st-line combinations in the
US
|
Press release, DuPont, 6 Feb 2001 |
|
Lifetime, discounted, direct medical costs of treating a
US
adult with HIV are estimated at US$96,000 |
PhRMA Web Page, 14 Feb 2001 |
|
Pan-Caribbean Partnership against HIV/AIDS set up to give 95% of 15-24year olds
access to services by 2005 |
Scrip Daily Online, 2 Mar 2001, S00700292 |
|
Annual market growth rate for antiretrovirals to 2007 predicted to be 3.9% |
SMi Conf HIV Ther (London), 2001 |
|
BMS to offer Videx and Zerit to sub-Saharan Africafor $1 a day |
Press release, BMS, 14 Mar 2001 |
|
UN secretary general seeks US$10 billion/yr global funding for HIV/AIDS |
Scrip Daily Online, 30 Apr 2001, S00707748 |
|
GSK extends drug discounts to all of its antiretrovirals in the 63 poorest countries |
Scrip Daily Online, 13 Jun 2001, S00713720 |
|
UNGASS aims to reduce HIV prevalence in 15-24yr olds by 25% by 2010 |
Scrip Daily Online, 28 Jun 2001, S00716166 |
|
AIDS vaccine predicted to be available by 2007-2011 |
6th Int Cong AIDS AsiaPacific, 7 Oct 2001 |
|
Anti-trust suit filed in the
US
against GlaxoSmithKline by AIDS Healthcare Foundation challenging GSK's exclusive
rights to zidovudine, lamivudine and abacavir. |
Press release, AIDS Healthcare Foundation, 1 Jul 2002 |
|
68 million predicted to die from AIDS between 2000 and 2020 in the 45 most affected
countries |
UN AIDS report, Jul 2002 |
|
Abbott's Kaletra becomes the most-prescribed protease inhibitor (29.5% share
in Europe, 28.6% in the
US
) |
Press release, Abbott, 2 Oct 2002 |
|
US market for HIV/AIDS therapies projected to reach US$10.88 million by 2009 |
Press release, Frost & Sullivan, 3 Feb 2003 |
|
Number of children who have lost one or both parents to AIDS projected to rise
to 25 million by 2010 |
Press release, UNAIDS, 22 Sep 2003 |
|
Agrrement with the William Jefferson Clinton Foundation set to reduce the cost
of antiretrovirals in developing countries by up to a half |
Press release, Ranbaxy, 27 Oct 2003 |
|
BMS announces a further US$30 million in new grants to African countries to fight
HIV/AIDS |
Press release, BMS, 25 Nov 2003 |
|
Large scale trials planned for 2 anti-HIV microbicides |
Preess release, Reuters, 23 Mar 2004 |
|
HIV drug market predicted to grow to US$8 billion by 2013 |
Press Release, Decision Resources, 28 April 2004 |
|
Kenya to expand antiretroviral access from 28,000 patients to 95,000 by the end
of 2005 |
Scrip Daily Online, 7 Feb 2005 S00871920 |
|
Roche will withdraw Fortovase in 1st qtr 2006 in favour of new saquinavir mesylate
formulation |
Press Release, Roche, 18 May 2005 |
Updated by IL on 20/05/2005.
RELATED WEBSITES
© PJB Publications Ltd 2006
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