Published on November 29, 2012
2012 ReportMedicines in DevelopmentHIV/AIDSpresented by america’s biopharmaceuticalresearch companies Biopharmaceutical Researchers Are Testing More Than 70 Medicines and Vaccines For HIV InfectionMedicines in Developmentfor HIV/AIDS 40 1.2 million Americans 25 are living with HIV, 50,000 are newly diagnosed each year 4 4 Biopharmaceutical research companies vaccine given to only a third of the population ls s py es or ira are developing 73 medicines and vaccines, could reduce new HIV infections by 24 percent ra cin lat tiv he du c focusing on improved treatment regimens, over 15 years. An Va eT mo more effective therapies and promising new en no The medicines in the development pipeline ll/G mu preventative vaccines. include: Ce Im Although HIV/AIDS is one of the most • gene therapy that uses genetic material to AMedicines in Development devastating diseases affecting people aroundfor HIV/AIDS by Phase of remove disease-causing aspects of the virus. the world, the number of new infections hasDevelopment been steadily declining. In the United States, • transdermal vaccine that helps suppress vi- A the AIDS-related death rate has fallen by 79 rus replication and destroys HIV-infected cells. 35 percent due to antiretroviral therapy. • first-in-class medicine intended to prevent the A 28 Over the past 30 years, nearly 40 medicines HIV virus from breaking through the cell membrane. have been approved to treat HIV/AIDS. Despite the incredible progress to date, the Testing for the disease also has advanced HIV/AIDS epidemic remains a complex prob- dramatically, enabling earlier treatment. While lem. America’s biopharmaceutical research 2 5 4 these medicines have helped to prolong the companies are continuing their efforts to de- lives of HIV-infected patients, making HIV a velop novel and more effective therapies, vac- manageable chronic disease, opportunities for cines to prevent the disease, and potentially a eI II I d itte n eI eI d ifie even greater progress remain. bm tio as cure, so the millions of patients suffering today as as Su lica ecPh Ph Ph sp For example, biopharmaceutical companies have hope for a better tomorrow. p Ap Un are intensifying their efforts to develop vac-* Some medicines are listed in more than one cines that would help prevent HIV. Currentphase of development. estimates show that a 50 percent effective
Medicines in Development for HIV/AIDS Antivirals Product Name Sponsor Indication Development Status* abacavir/dolutegravir/lamivudine ViiV Healthcare HIV infection therapy in Phase III fixed-dose combination Rsch. Triangle Park, NC treatment-naive patients (877) 844-8872 (integrase inhibitor/reverse transcriptase inhibitor) amdoxovir (DAPD) RFS Pharma HIV-1 infection treatment Phase II Tucker, GA (404) 601-1430 BI-224436 Gilead Sciences HIV infection treatment Phase I completed (integrase inhibitor) Foster City, CA (800) 445-3235 CB1922 Canopus BioPharma HIV infection treatment Phase II (synthetic steroidal lactone) Studio City, CA www.canopusbiopharma.com cenicriviroc Tobira Therapeutics HIV-1 infection treatment Phase II (CCR5 receptor antagonist) South San Francisco, CA (650) 741-6625 CMX157 Merck HIV infection treatment Phase I completed (tenofovir PIM conjugate) Whitehouse Station, NJ (800) 672-6372 cobicistat Gilead Sciences HIV infection treatment application submitted (PK enhancer) Foster City, CA (800) 445-3235 cobicistat/darunavir Gilead Sciences HIV infection Phase I fixed-dose combination Foster City, CA (800) 445-3235 (PK enhancer/protease Janssen Therapeutics (800) 526-7736 inhibitor) Titusville, NJ cobicistat/darunavir/ Gilead Sciences HIV-1 infection Phase II emtricitabine/GS-7340 Foster City, CA (800) 445-3235 fixed-dose combination Janssen Therapeutics (800) 526-7736 Titusville, NJ cobicistat/elvitegravir/ Gilead Sciences HIV-1 infection Phase II emtricitabine/GS-7340 Foster City, CA (800) 445-3235 fixed-dose combination dapivirine International Partnership for HIV infection prevention Phase I/II completed (NNRTI) Microbicides (vaginal ring) (301) 608-2221 Silver Spring, MD -------------------------------------------------- ------------------------------------------- HIV infection prevention Phase I/II completed (vaginal gel) (301) 608-2221 dolutegravir Shionogi HIV-1 infection treatment Phase III (S/GSK1349572) Florham Park, NJ (973) 966-6900 (integrase inhibitor) ViiV Healthcare (877) 844-8872 Rsch. Triangle Park, NC*For more information about a specific medicine in this report, please call the telephone number listed.2 Medicines in Development HIV/AIDS 2012
Medicines in Development for HIV/AIDS Antivirals Product Name Sponsor Indication Development Status efavirenz/lamivudine/ Mylan Laboratories HIV-1 infection treatment application submitted tenofovir fumarate Canonsburg, PA (724) 514-1800 fixed-dose combination elvitegravir Gilead Sciences HIV-1 infection treatment application submitted (integrase inhibitor) Foster City, CA (800) 445-3235 elvucitabine Achillion Pharmaceuticals HIV infection treatment Phase II (NRTI) New Haven, CT (203) 624-7000 GS-7340 Gilead Sciences HIV infection treatment Phase II (NtRTI) Foster City, CA (800) 445-3235 HIV attachment inhibitor Bristol-Myers Squibb HIV infection treatment Phase II Princeton, NJ (800) 332-2056 HIV maturation inhibitor Bristol-Myers Squibb HIV infection treatment in clinical trials Princeton, NJ (800) 332-2056 ibalizumab TaiMed Biologics USA HIV-1 infection treatment Phase II (TMB-355) Irvine, CA (intravenous) (Fast Track) (949) 769-6543 (fusion inhibitor) -------------------------------------------------- ------------------------------------------- HIV-1 infection treatment Phase I (subcutaneous) (949) 769-6543 Intelence® Janssen Therapeutics HIV infection combination therapy in Phase II etravirine Titusville, NJ treatment-naive patients (800) 526-7736 (NNRTI) (Fast Track) KD-247 Kaketsuken HIV-1 infection treatment Phase I (monoclonal antibody) Kumamoto, Japan www.kaketsuken.or.jp KP-1461 Koronis Pharmaceuticals HIV infection treatment Phase II (replication inhibitor) Redmond, WA (425) 825-0240 lamivudine (3TC)/lopinavir/ Abbott Laboratories HIV-1 infection treatment in clinical trials ritonavir fixed-dose Abbott Park, IL (847) 937-6100 combination lamivudine (3TC)/maraviroc/ GlaxoSmithKline HIV infection Phase I completed zidovudine fixed-dose Rsch. Triangle Park, NC (888) 825-5249 combination lersivirine (UK-453061) ViiV Healthcare HIV infection treatment Phase II (NNRTI) Rsch. Triangle Park, NC (877) 844-8872 Lexiva® Vertex Pharmaceuticals HIV infection treatment in Phase II fosamprenavir Cambridge, MA adolescents, children and infants (617) 444-6100 (PI) ViiV Healthcare (877) 844-8872 Rsch. Triangle Park, NCMedicines in Development HIV/AIDS 2012 3
Medicines in Development for HIV/AIDSAntiviralsProduct Name Sponsor Indication Development StatusMK-1439 Merck HIV-1 infection treatment Phase I(NNRTI) Whitehouse Station, NJ (800) 672-6273Norvir® Abbott Laboratories HIV infection treatment in clinical trialsritonavir Abbott Park, IL (847) 937-6100powdered formulation(PI)NRT inhibitor Bristol-Myers Squibb HIV infection treatment Phase II Princeton, NJ (800) 332-2056Prezista® Janssen Therapeutics HIV infection application submitteddarunavir Titusville, NJ (800) 526-7736(once-daily 800 mg)PRO 140 CytoDyn HIV-1 infection prevention and Phase II completed(CCR5 receptor antagonist) Lake Oswego, OR treatment (971) 204-0382RAP101 RAPID Pharmaceuticals HIV infection treatment Phase II(CCR5 receptor antagonist) Huenenberg, Switzerland www.rapidpharma.comRPI-MN ReceptoPharm HIV infection treatment Phase I Plantation, FL (954) 321-8988S/GSK1265744 Shionogi HIV infection treatment Phase II(integrase inhibitor) Florham Park, NJ (973) 966-6900 ViiV Healthcare (877) 844-8872 Rsch. Triangle Park, NCSPL-7013 Starpharma HIV infection prevention Phase I completed(vaginal gel) Melbourne, Australia (Fast Track) www.starpharma.comTBR-220 Tobira Therapeutics HIV infection treatment Phase I(CCR5 receptor antagonist) South San Francisco, CA (650) 741-6625tenofovir vaginal gel CONRAD HIV infection prevention Phase I(NtRTI) Arlington, VA (703) 524-4744 International Partnership for Microbicides Silver Spring, MDTMC310911 Janssen Therapeutics HIV infection treatment Phase II completed(PI) Titusville, NJ (800) 526-77364 Medicines in Development HIV/AIDS 2012
Medicines in Development for HIV/AIDS Antivirals Product Name Sponsor Indication Development Status UB-421 United Biomedical HIV-1 infection treatment Phase II (FI) Hauppauge, NY (631) 273-2828 VRX806 Valeant Pharmaceuticals HIV infection treatment Phase II (NNRTI) Mississauga, Canada (905) 286-3000 Cell Therapy/Gene Therapy Product Name Sponsor Indication Development Status HIV gene therapy Adaptimmune HIV infection Phase I Philadelphia, PA (267) 499-2066 Cardiff University Cardiff, Wales University of Pennsylvania Philadelphia, PA lexgenleucel-T VIRxSYS HIV infection therapy in Phase II (replication inhibitor) Gaithersburg, MD treatment-experienced patients (301) 987-0480 SB-728-T Sangamo BioSciences HIV infection treatment Phase II Richmond, CA (510) 970-6000 Stealth Vector® Enzo Therapeutics HIV-1 infection treatment Phase I/II HGTV-43™ New York, NY (212) 583-0100 antisense gene medicine Immunomodulators Product Name Sponsor Indication Development Status AMZ0026 Amazon Biotech HIV infection treatment Phase I/II New York, NY (212) 444-1019 CYT107 Cytheris HIV infection treatment Phase II (recombinant human Rockville, MD (301) 231-0450 interleukin-7) Cytolin® CytoDyn HIV infection treatment Phase I anti-CD8 mAb Lake Oswego, OR (971) 204-0382 IRT-103 TNI BioTech HIV infection treatment Phase II (low-dose naltrexone) New York, NY www.tnibiotech.comMedicines in Development HIV/AIDS 2012 5
Medicines in Development for HIV/AIDSVaccinesProduct Name Sponsor Indication Development StatusADVAX Aaron Diamond AIDS Research HIV infection prevention Phase I completed(DNA vaccine) Center (212) 448-5000 New York, NY (212) 847-1111 International AIDS Vaccine Initiative -------------------------------------------------- ------------------------------------------- New York, NY HIV infection prevention Phase I completed Ichor Medical Systems (new delivery system) (212) 448-5000 San Diego, CA (212) 847-1111AGS-004 Argos Therapeutics HIV-1 infection treatment Phase II(autologous dendritic cell Durham, NC (919) 287-6300vaccine-intradermal injection)AVX101 AlphaVax HIV-1 infection prevention Phase I(single gene HIV vaccine) Rsch. Triangle Park, NC (919) 595-0400DCVax-001 Celldex Therapeutics HIV infection prevention and Phase I(recombinant protein vaccine) Needham, MA treatment (781) 433-0771 Rockefeller University New York, NYDermaVir™ Patch Genetic Immunity HIV-1 infection treatment Phase IIDNA topical patch vaccine McLean, VA (703) 879-6803HIV gp41 vaccine Mymetics HIV infection prevention Phase I Epalinges, Switzerland www.mymetics.comHIV recombinant vaccine GlaxoSmithKline HIV-1 infection prevention Phase I Rsch. Triangle Park, NC (888) 825-5249HIV vaccine Crucell HIV infection prevention Phase I Leiden, The Netherlands (212) 847-1111 Beth Israel Deaconess Medical Center Boston, MA International AIDS Vaccine Initiative New York, NYHIV vaccine GeoVax Labs HIV infection prevention Phase II Smyrna, GA (678) 384-7220HIV vaccine GeoVax Labs HIV infection treatment Phase I/II Smyrna, GA (678) 384-72206 Medicines in Development HIV/AIDS 2012
Medicines in Development for HIV/AIDS Vaccines Product Name Sponsor Indication Development Status HIV vaccine Massachusetts General Hospital HIV infection Phase I Boston, MA (617) 726-2000 Opal Therapeutics Parkville, Australia HIV vaccine Novartis Vaccines & Diagnostics HIV infection Phase I Cambridge, MA (617) 871-7000 National Institutes of Health Bethesda, MD HIV vaccine PaxVax HIV infection prevention in clinical trials San Diego, CA (858) 450-9595 HIV vaccine Profectus Biosciences HIV-2 infection prevention Phase I (MAG pDNA) Baltimore, MD (866) 938-8559 HIV vaccine Profectus Biosciences HIV infection prevention Phase I (rVSV) Baltimore, MD (866) 938-8559 HIV vaccine Sumagen HIV-1 infection Phase I (SAV001) Seoul, South Korea www.sumagen.co.kr HIVAX™ GeneCure Biotechnologies HIV-1 infection Phase I replication-defective Norcross, GA (770) 263-7508 HIV-1 vaccine ITV-1 Immunotech Laboratories HIV infection treatment in clinical trials immune therapeutic vaccine Pasadena, CA (818) 409-9091 Pennvax®-B Inovio Pharmaceuticals HIV infection prevention and Phase I DNA vaccine (clade B) Blue Bell, PA treatment (267) 440-4200 Pennvax®-G Inovio Pharmaceuticals HIV infection prevention Phase I DNA vaccine (clades A, C, D) Blue Bell, PA (267) 440-4200 TUTI-16 Thymon HIV-1 infection treatment Phase I/II (lipoprotein vaccine) Short Hills, NJ (973) 467-9558 vacc-4x Bionor Pharma HIV-1 infection treatment Phase II (intradermal vaccine) Oslo, Norway www.bionorpharma.comMedicines in Development HIV/AIDS 2012 7
Medicines in Development for HIV/AIDS Vaccines Product Name Sponsor Indication Development Status VRC-HIVADV014-00-VP GenVec HIV infection prevention Phase II completed (HIV-1 recombinant adenovirus Gaithersburg, MD www.vrc.nih.gov vaccine) Vaccine Research Center (NIAID) Bethesda, MD VRC-HIVADV027-00-VP GenVec HIV infection prevention Phase I (HIV adenovector Ad35 vaccine) Gaithersburg, MD www.vrc.nih.gov Vaccine Research Center (NIAID) Bethesda, MD VRC-HIVDNA016-00-VP Vaccine Research Center (NIAID) HIV infection prevention Phase II Bethesda, MD www.vrc.nih.govThe content of this report has been obtained through public, government and industry sources, and the Adis “R&D Insight” database based on thelatest information. Report current as of November 16, 2012. The information in this report may not be comprehensive. For more specific informa-tion about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Developmentis available on PhRMA’s web site.A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.infoProvided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.Copyright © 2012 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given.Pharmaceutical Research and Manufacturers of America • 950 F Street, NW, Washington, DC 200048 Medicines in Development HIV/AIDS 2012
Approved Medicines for HIV Infection/AIDS Entry Inhibitors • Selzentry® (maraviroc) ViiV Healthcare • Fuzeon® (enfuvirtide) Genentech, Trimeris Integrase Inhibitor • Isentress® (raltegravir) Merck Nucleoside Reverse Transcriptase Inhibitors (NRTI) • Combivir® (lamivudine/zidovudine) ViiV Healthcare • Emtriva® (emtricitabine) Gilead Sciences • Epivir® (lamivudine) ViiV Healthcare • Epzicom® (abacavir/lamivudine) ViiV Healthcare • Hivid® (zalcitabine) Roche, marketing discontinued • Retrovir® (zidovudine) ViiV Healthcare • Trizivir® (abacavir/lamivudine/zidovudine) ViiV Healthcare • Videx® (didanosine) Bristol-Myers Squibb • Videx® EC (didanosine delayed release) Bristol-Myers Squibb • Zerit® (stavudine) Bristol-Myers Squibb • Zerit® XR (stavudine extended-release) Bristol-Myers Squibb, marketing discontinued • Ziagen® (abacavir) ViiV Healthcare Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) • Edurant™ (rilpivirine) Janssen Therapeutics • Intelence® (etravirine) Janssen Therapeutics • Rescriptor® (delvaridine) ViiV Healthcare • Sustiva® (efavirenz) Bristol-Myers Squibb • Viramune® (nevirapine) Boehringer Ingelheim Pharmaceuticals • Viramune®XR™ (nevirapine extended-release) Boehringer Ingelheim PharmaceuticalsMedicines in Development HIV/AIDS 2012 9
Approved Medicines for HIV Infection/AIDS Nucleotide Reverse Transcriptase Inhibitor (NtRTI) • Viread® (tenofovir disoproxil fumarate) Gilead Sciences Protease Inhibitors • Agenerase® (amprenavir) GlaxoSmithKline, Vertex Pharmaceuticals • Aptivus® (tipranavir) Boehringer Ingelheim Pharmaceuticals • Crixivan® (indinavir) Merck • Fortovase® (saquinavir soft-gel) Roche, marketing discontinued • Invirase® (saquinavir) Genentech • Kaletra® (lopinavir/ritonavir) Abbott Laboratories • Lexiva® (fosamprenavir) ViiV Healthcare, Vertex Pharmaceuticals • Norvir® (ritonavir) Abbott Laboratories • Prezista® (darunavir) Janssen Therapeutics • Reyataz® (atazanavir) Bristol-Myers Squibb • Viracept® (nelfinavir) ViiV Healthcare Combination Medicines NNRTI/NRTI/NtRTI • Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Bristol-Myers Squibb, Gilead Sciences NRTI/NNRTI/NtRTI • Complera™ (emtricitabine/rilpivirine/tenofovir, disoproxil fumarate) Gilead Sciences Integrase Inhibitor/PK Enhancer/NRTI/NtRTI • Stribild™ (elvitegravor/cobicistat/emtricitabine/tenofvoir disoproxil fumarate) Gilead Sciences NRTI/NtRTI • Truvada® (emtricitabine/tenofovir disoproxil fumarate) Gilead Sciences10 Medicines in Development HIV/AIDS 2012
Glossaryapplication submitted—An application for in the virus’ replication, blocking it can halt promising drugs by establishing very early onmarketing has been submitted by the company further spread of the virus. whether the agent behaves in human subjectsto the Food and Drug Administration (FDA). as was anticipated from preclinical studies. PK enhancer—Pharmacokinetic (PK) en-entry inhibitor—Unlike other HIV drugs that hancer increases the effectiveness of pharma- Phase I—Researchers test the drug in a smallwork after HIV has entered the human immune ceutical treatment. group of people, usually between 20 and 80cell, entry inhibitors work outside the CD4 healthy adult volunteers, to evaluate its initial reverse transcriptase inhibitor (RTI)—Whencell, blocking the virus from entering the cell. safety and tolerability profile, determine a HIV infects a cell, reverse transcriptaseThe process of HIV entry into a cell requires a safe dosage range, and identify potential side changes the single-stranded RNA into aseries of steps in sequence involving several effects. double-stranded viral DNA. The new viral DNAkey proteins. Different entry inhibitors target is then integrated into the human DNA cells, al- Phase II—The drug is given to volunteerseparate proteins in the process. One type of lowing reproduction of the virus. RTIs block this patients, usually between 100 and 300, to seeentry inhibitor blocks the attachment of the HIV action and prevent completion of synthesis of if it is effective, identify an optimal dose, and toprotein gp120 to CD4 cell receptors on the cell the double-stranded viral DNA, preventing HIV further evaluate its short-term safety.surface. Another inhibitor targets the binding from multiplying. RTIs are a class of antiretro-of the virus to CCR5 or CXCR4 co-receptors Phase III—The drug is given to a larger, more viral drugs.involved in the virus entering the cell. And a diverse patient population, often involving be-third entry inhibitor interferes with the fusion of NRTI—Nucleoside reverse transcriptase tween 1,000 and 3,000 patients (but sometimethe HIV virus with T-cells at the cell membrane. inhibitor. many more thousands), to generate statistically significant evidence to confirm its safety andHIV infection—The presence of antibodies in NNRTI—Non-nucleoside reverse transcriptase effectiveness. They are the longest studies,the blood to the human immunodeficiency virus inhibitor. and usually take place in multiple sites around(the virus that causes AIDS). HIV-1 refers to NtRTI—Nucleotide reverse transcriptase the world.the most common strain of the virus found inU.S. AIDS patients. inhibitor. PI—Protease inhibitors are a class of antiret- Phase 0—First-in-human trials conducted roviral drugs used to treat HIV infection. Theyintegrase inhibitor— A class of antiretroviral in accordance with FDA’s 2006 guidance on prevent the HIV virus from replicating by inhib-drugs designed to block the action of integrase, exploratory Investigational New Drug (IND) iting the activity of proteases, such as HIV-1.an enzyme that inserts the virus into the DNAof human cells. Since integration is a vital step studies designed to speed up development ofMedicines in Development HIV/AIDS 2012 11
Selected Facts about HIV/AIDS Overview U.S. AIDS Diagnoses through 20101 U.S. AIDS Deaths through 20091 Adults/Adolescents 1,119,651 614,394 Pediatric (under age 13) 9,475 4,986 TOTAL 1,163,575* 641,976* * ecause totals for the estimated numbers were calculated independently of the values for the subpopulations, the subpopulation values may not B equal these totals. HIV/AIDS Worldwide 2 • In 2010, 2.7 million people became newly infected with HIV infection (including 390,000 children younger than age 15), down from 3.1 million in 2001. Although the annual number of people newly infected with HIV has dropped since its peak in the late 1990s, it is still occur- ring at an unacceptably high rate: between 2.5 million and 3 million people annually for the past five years, adding to the global number of people living with HIV that reached 34 million (including 3.4 million children younger than age 15) by the end of 2010. • Globally, the annual number of people newly infected with HIV continues to decline, although there is stark regional variation. In sub-Saharan Africa, where most of the people newly infected with HIV live, an estimated 1.9 million people became infected in 2010. That was 16 percent fewer than the estimated 2.2 million people newly infected with HIV in 2001, and 27 percent fewer than the annual number of people newly infected between 1996 and 1998, when the incidence of HIV in sub-Saharan Africa peaked overall. • Reductions in the number of people acquiring HIV infection, especially people ages 15–24 in the countries in sub-Saharan Africa that have a high burden of HIV, have been offset by increases in new infections in Eastern Europe and Central Asia. In those areas, where the primary mode of transmission of HIV is among people who inject drugs and their sexual networks, the number of people dying from AIDS-related causes increased 1,100 percent during the past decade: from an estimated 7,800 in 2001 to 89,500 in 2010. • The annual number of people dying from AIDS-related causes worldwide is steadily decreasing from a peak of 2.2 million in 2005 to an estimated 1.8 million in 2010. That year, an estimated 250,000 children younger than age 15 died from AIDS-related causes, 20 percent fewer than in 2005. The number of people dying from AIDS-related causes began to decline in 2005–2006 in sub-Saharan Africa, South and Southeast Asia and the Caribbean and has continued subsequently. • Introducing antiretroviral therapy has averted 2.5 million AIDS deaths in low- and middle-income countries globally since 1995. Sub- Saharan Africa accounts for the vast majority of the averted deaths: about 1.8 million. • Providing antiretroviral prophylaxis to pregnant women living with HIV has prevented more than 350,000 children from acquiring HIV infection since 1995. Eighty-six percent of the children who avoided infection live in sub-Saharan Africa, the region with the highest prevalence of HIV infection among women of reproductive age.12 Medicines in Development HIV/AIDS 2012
Selected Facts about HIV/AIDS HIV/AIDS in the United States 1• In 2010, an estimated 48,298 people were newly diagnosed with HIV infection in the 46 states and 5 U.S. dependent areas with confidential name-based HIV infection reporting. In the 46 states, 46,912 adults and adolescents were newly diagnosed with HIV infection, with 37,045 diag- noses in males and 9,868 diagnoses in females. Among children younger than age 13, there were an estimated 217 diagnoses of HIV infection.• At the end of 2009, an estimated 1,148,200 people age 13 and older were living with HIV infection in the United States, including 207,600 people whose infections had not been diagnosed.• In 2009, the estimated number of deaths of people with a diagnosis of HIV infection in the 46 states and 5 U.S. dependent areas with confidential name-based HIV infection reporting was 21,601. In the 46 states only, that included 21,007 adults and adolescents and 8 children younger than age 13.• In 2010, the estimated number of people diagnosed with AIDS in the United States and 6 U.S. dependent areas was 33,630. In the 50 states and the District of Columbia, 24,749 AIDS diagnoses were among adult and adolescent males, 8,242 were among adult and adolescent females, and 23 diagnoses were among children younger than age 13.• In 2009, the estimated number of deaths of people with an AIDS diagnosis in the United States and 6 U.S. dependent areas was 18,234. In the 50 states and the District of Columbia, that included 17,770 adults and adolescents and 4 children younger than age 13. HIV/AIDS Economic Impact• The lifetime treatment cost of an HIV infection can be used as a conservative threshold value for the cost of averting one infection. Currently, the lifetime treatment cost of an HIV infection is estimated at $379,668 (in 2010 dollars); therefore, a prevention intervention is deemed cost-saving if its cost-effectiveness (CE) ratio is less than $379,668 per infection averted. The average annual cost of HIV care in the antiretroviral (ART) era is estimated to be $19,912 (in 2006 dollars; $23,000 in 2010 dollars). One study has estimated the medical savings from infections averted by United States prevention programs from 1991-2006 to be $129.9 billion with 361,878 HIV infections averted.1• Nearly 30 years into the HIV epidemic, HIV continues to take a heavy toll in the United States. More than 1.1 million people are currently living with HIV, nearly 18,000 people with AIDS still die each year, and lifetime medical care for those who become infected with HIV each year is estimated to cost $20 billion.1• Without intervention, a perinatal HIV transmission rate of 25 percent would result in 1,750 HIV-infected infants born annually in the United States with lifetime medical costs estimated to be $282 million. The cost of intervention (HIV counseling, testing, and zidovu- dine treatment) was estimated to be $67.6 million. That intervention would prevent 656 pediatric HIV infections, saving $105.6 million in medical care costs—a net cost-savings of $38.1 million annually.3 Sources:1. U.S. Centers for Disease Control and Prevention, HIV Surveillance Report: Diagnoses of HIV Infection and AIDS in the United States and Dependent Areas, 2010; Vol. 22., www.cdc.gov2. World Health Organization (WHO), www.who.int/en3. KidSource OnLine, Inc., www.kidsource.comMedicines in Development HIV/AIDS 2012 13
The Drug Discovery, Development and Approval Process Developing a new medicine takes an average of 10-15 years; For every 5,000-10,000 compounds in the pipeline, only 1 is approved.The Drug Development and Approval ProcessThe U.S. system of new drug approvals is in people. The IND shows results of previous statistically significant evidence to confirm itsperhaps the most rigorous in the world. experiments; how, where and by whom the safety and effectiveness. They are the longest new studies will be conducted; the chemical studies, and usually take place in multiple sitesIt takes 10-15 years, on average, for an structure of the compound; how it is thought around the world.experimental drug to travel from lab to U.S. to work in the body; any toxic effects found inpatients, according to the Tufts Center for the New Drug Application (NDA)/Biologic the animal studies; and how the compoundStudy of Drug Development. Only five in 5,000 License Application (BLA). Following the is manufactured. All clinical trials must becompounds that enter preclinical testing make completion of all three phases of clinical trials, reviewed and approved by the Institutionalit to human testing. And only one of those five a company analyzes all of the data and files an Review Board (IRB) where the trials will beis approved for sale. NDA or BLA with FDA if the data successfully conducted. Progress reports on clinical trials demonstrate both safety and effectiveness.On average, it costs a company $1.2 billion, must be submitted at least annually to FDA and The applications contain all of the scientificincluding the cost of failures, to get one new the IRB. information that the company has gathered.medicine from the laboratory to U.S. patients, Clinical Trials, Phase I—Researchers test Applications typically run 100,000 pages oraccording to a 2007 study by the Tufts Center the drug in a small group of people, usually more.for the Study of Drug Development. between 20 and 80 healthy adult volunteers, to Approval. Once FDA approves an NDA orOnce a new compound has been identified in evaluate its initial safety and tolerability profile, BLA, the new medicine becomes availablethe laboratory, medicines are usually devel- determine a safe dosage range, and identify for physicians to prescribe. A company mustoped as follows: potential side effects. continue to submit periodic reports to FDA,Preclinical Testing. A pharmaceutical com- Clinical Trials, Phase II—The drug is given including any cases of adverse reactions andpany conducts laboratory and animal studies to volunteer patients, usually between 100 and appropriate quality-control records. For someto show biological activity of the compound 300, to see if it iseffective, identify an optimal medicines, FDA requires additional trialsagainst the targeted disease, and the com- dose, and to further evaluate its short-term (Phase IV) to evaluate long-term effects.pound is evaluated for safety. safety. Discovering and developing safe and effectiveInvestigational New Drug Application (IND). Clinical Trials, Phase III—The drug is given to new medicines is a long, difficult, and expensiveAfter completing preclinical testing, a company a larger, more diverse patient population, often process. PhRMA member companies investedfiles an IND with the U.S. Food and Drug involving between 1,000 and 3,000 patients (but an estimated $49.5 billion in research andAdministration (FDA) to begin to test the drug sometime many more thousands), to generate development in 2011.
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