Table of Contents
High Incidence of Infectious Diseases Persists, While Treatment Options Remain Scarce
Latin America presents many opportunities for the infectious diseases market. This market insight offers an overview of the human immunodeficiency virus (HIV), Chagas, dengue, and influenza H1N1 therapeutics markets in Latin America. General market trends are covered, and a competitive landscape, which highlights current drugs on the market as well as drugs in clinical trial, is given for each disease type. Key statistics include the relative prevalence of each disease in Latin America. Conclusions and recommendations are also provided. The base year is 2012, with some timelines extending to 2018.
Methodology and Scope
• This research service focuses on antiviral and antiretroviral therapeutics for the treatment of human immunodeficiency virus (HIV), Chagas, dengue, and influenza H1N1.
• This deliverable includes information regarding the challenges and trends in these markets, detailed analyses of products in these markets and their development in Latin America, and an overview of clinical trials and projected launch timelines.
• The information contained in this research service was derived from interviews with key opinion leaders in the industry and from published sources, including the following: disease organization Web sites, public health organization Web sites, company publications, press releases, government public sources, and published articles in scientific journals.
Key Findings—HIV Therapeutics
Latin American HIV Therapeutics industry
• Most of the ongoing HIV clinical trials are being conducted by multinationals. Local companies are not investing in research and development (R&D) for HIV therapeutics.
• Local growth in the Latin American HIV therapeutics market is needed.
• In Latin America, GSK currently marketsXproducts for the treatment of HIV: Combivir and Trizivir. The key advantages of Combivir and Trizivir are their single tablet regimens (STRs), which reduce the required number of daily pill intakes and improve patient adherence.
• GSK plans to expand its portfolio of HIV treatments with its integrase inhibitor, GSK1349572 (Dolutegravir), which is currently in Phase 3 development.
oPhase 3 clinical trials are being conducted in Argentina, Brazil, Chile, and Mexico for patients with Raltegravir resistance.
oThe launch of Dolutegravir in Latin American is expected in 2016.
oAdvantages include its antiviral activity with once daily, unboosted dosing.
• Gilead Sciences is also developing an STR* (single tablet EVG, FTC, and TDF*) to improve patient adherence in the treatment of HIV; its launch is anticipated for 2015.
• Cobicistat (GS-9350) a key development program in the treatment of HIV for Gilead Sciences.
oCobicistat is a selective inhibitor of human cytochrome and is in Phase 3 development in Latin America.
oClinical trails are being conducted in Argentina, Brazil, and Mexico.
oKey opinion leaders (KOLs) report that the drug does not attack the virus directly but that it does improve the effectiveness of other HIV drugs when combined with EVG, FTC, and TDF.
oCobicistat’s launch is expected in 2015.
World Health Organization (WHO)
• The new WHO guidelines for HIV treatment have established that infected patients must receive therapeutic intervention earlier.
• When a patient has blood levels of CD4* that are under 500 cells/cubic millimeter or when a patient is a pregnant women, a child under 5 years old, or is considered risky, medication for the treatment of HIV must be given immediately.
• Until 2012, Brazil was the only Latin American country with a local company, Lafepe, that supplied medication for Chagas.
• Now, Elea Laboratory (Argentina) offers Abarax (benznidazole) for the treatment of Chagas in Latin America.
• Due to a limited number of suppliers, drug shortages remain a challenge for treating Chagas in Latin America.
• In addition, there is a need for second-line therapies for patients that do not see a positive effect with benznidazole.
• E1224 is a drug in Phase 2 clinical investigation for the treatment of Chagas in Bolivia.
oE1224 is showing promising results in the treatment of patients with Chagas due to its potent activity against the parasite trypanosoma cruzi.
oClinical trial results reported to date indicate that the drug is more effective than benznidazole and well tolerated by chronically infected patients.
• The dengue therapeutics market in Latin America is highly under-developed.
• No vaccines or treatments that would prevent the disease are available, and the launch of any such treatments is not expected to occur in the short term.
• One vaccine, the CYD-TDV dengue vaccine, is currently being evaluated by Sanofi-Pasteur.
oLaunch is not expected sooner than 2017.
oThe vaccine has potential to be effective at preventing serotypes I, III, and IV of the dengue virus.
Key Findings—Influenza H1N1
• Several generics are available for the treatment of influenza H1N1 in Latin America.
• However, an unmet need still remains for more convenient therapies with long-term effectiveness and for more treatment options for oseltamivir-intolerant patients.
• Biota Scientific Management Pty Ltd. is conducting clinical trials for the development of laninamivir, a neuraminidase inhibitor that has demonstrated effectiveness for the treatment of influenza.
oClinical trials are being conducted in Argentina, Brazil, Chile, Colombia, Mexico, and Peru.
oIts launch is anticipated for 2017.
• GSK is also investigating an intravenously administered version of its already marketed drug, zanamivir, for hospitalized patients.
oClinical trials are being conducted in Brazil.
oIts launch is anticipated for 2017.
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