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MACVSc Vice President Pharmaceutical Research & Development Fort Dodge Animal Health • Active ingredient: moxidectin • Macrocyclic lactone • Anthelmintic agent • Dogs, horses, cattle, sheep, swine • Co-development with WHO for humans • Onchocerciasis (river blindness) ProHeart 6 Introduction • Innovative Product • A single dose provides 6 months protection from heartworm disease caused by Dirofilaria immitis • Treats existing hookworm infections • Overcomes compliance failures associated with monthly heartworm preventives ProHeart 6 Introduction Moxidectin Extensive Toxicology Database • Receptor-mediated adverse pharmacologic/toxicologic effects not expected (new study) • Toxicology studies of up to 2 years in mice and rats and 1 year in dogs showed no adverse histologic or biochemical effects on any organ system • Exposure (AUC) of dogs to moxidectin in toxicology studies were 454-fold higher than after 2 doses of ProHeart 6 given 6 months apart (new study) • No increase in tumors in 2-year carcinogenicity studies • Safety study results demonstrate • Wide margin of safety • Safe in breeding animals • Safe in unique canine populations • Ivermectin-sensitive • Heartworm positive • 100% efficacy at commercial dose • 100% efficacy in large number (84) of breeds • A total of 770 dogs were evaluated for US registration Pre-Approval ProHeart 6 Clinical Study Results Factors Limiting Heartworm Control in US Dogs • Widespread availability of heartworm preventives has not changed the infection rates in last 10 years • 240,000 dogs in US tested positive for heartworm nationwide in 2001 • One-fifth of surveyed dog owners stopped giving their dogs the monthly oral preventive altogether • Approved and marketed globally • US – June 2001 • Canada, Japan, Italy, France, Spain, Portugal, Greece, Korea • ProHeart SR 12 • Australia – October 2000 • 12 months heartworm protection • 3 times ProHeart 6 dose ProHeart 6 Approval • Rapid and broad acceptance by dog owners and veterinary professionals • 24% US market share • 47% Australian market share ProHeart 6 Market Experience 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0% Heartgard Heartgard Plus Interceptor Iverhart Plus ProHeart 6 Revolution Sentinel Q3 2001 Q4 2001 Q1 2002 Q2 2002 Q3 2002 Q4 2002 Q1 2003 Q2 2003 Q3 2003 Q4 2003 Q1 2004 Q2 2004 Source: June 2004 Doane Market Research: Heartworm Tracking Study Brand Share Change 2001 - 2004 Dispensed Units ProHeart 12 - Australia 0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00% 50.00% Ca nim ax / H ea rt Ex elp et He ar tga rd C he w He ar tga rd Pl us He ar tga rd T ab s Pr oh ea rt SR 12 Pr oh ea rt Ta bs Re vo lut ion Ad va nt ag e& A dv oc ate In ter cep tor Se nti na l/ P lus M ar-02 Jun-02 Se p-02 De c-02 M ar-03 Jun-03 Se p-03 De c-03 M ar-04 Jun-04 Se p-04 US and Australian AER Reports US Australia Doses sold 18,000,000 2,000,000 AER rate 2.5 1.6 (per 10,000 doses) Allergy reporting rate 1.3 0.8 (per 10,000 doses) Death reporting rate 0.3 0.1 (per 10,000 doses) • September 2004: FDAH voluntary recall of ProHeart 6 based on CVM concerns about adverse events • Data reviewed by Canadian, Australian, European, and Japanese regulatory authorities • Confirmed authority to continue marketing ProHeart 6 Introduction • Large independent nation-wide database: Banfield The Pet Hospital™ • Nearly 7 million “encounters” (office visits) • ProHeart 6, two heartworm preventives, vaccines were evaluated • Results demonstrate no clinically significant increase in adverse events following ProHeart 6 treatment • ProHeart 6 safety profile similar to 2 monthly heartworm preventives ProHeart 6 Epidemiological Evaluation (presented by Dr. Larry Glickman, Purdue University) • Post-marketing monitoring of AERs • Overall reporting rate is low • Reporting rate is declining • Most AERs appear to be allergic and self limiting • Assignment of causality confounded by concurrent vaccinations • Varied non-allergic AERs reflect diseases often seen in dogs Re-Evaluation of AERs by FDAH (presented by Dr. David Hustead, FDAH) ProHeart 6Safety Assessmentby Fort Dodge Animal Health ProHeart 6 Introduction ProHeart 6 Introduction MoxidectinExtensive Toxicology Database Pre-Approval ProHeart 6 Clinical Study Results Factors Limiting Heartworm Control in US Dogs ProHeart 6 Market Experience Brand Share Change2001 - 2004 Dispensed Units US and Australian AER Reports ProHeart 6 Introduction ProHeart 6 Epidemiological Evaluation(presented by Dr.
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Score: 1927638.3 - https://www.who.int/tdr/public...ts/moxidectin-13-pres-cobb.pdf
Data Source: un
Livestock can become infected with rabies by dogs or wildlife, resulting in economic losses and impacting food security. (...) Recent achievement made in the prevention of dogborne diseases is the development of multisectoral Dog Population Management strategy approved by City Governor Office. (...) Community participation, education and public awareness are important elements of successful rabies control programmes, and mass vaccination of dogs is critical. Communities need to take responsibility for their dogs, prevent dog bites and know what to do when bitten.
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Score: 1799006.8 - https://www.who.int/mongolia/n...-day-2013-observed-in-mongolia
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However, a community approach to reducing breeding of the mosquitos that can carry dengue is starting to pay off. (...) WHO/TDR/Maricel Seeger The Salto team began with surveys and home visits to find out what residents knew about dengue, and where the mosquito was breeding. Most people knew of the disease and how it’s transmitted, but they weren’t doing much to prevent mosquito breeding in households. (...) Edna Solaris, a Municipality of Salto worker, says, “Before we went to homes and we saw them full of water bottles, buckets, bowls for dog food which weren’t washed. And now we enter and we can see that the dog's bowls are clean.
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Score: 1786020.7 - https://www.who.int/tdr/news/2...gue-vector-control-uruguay/en/
Data Source: un
Regular supply and availability of dog rabies vaccines will also benefit dog immunization programmes in neighbouring countries such as Mozambique, Lesotho and Swaziland. Dog vaccine banks provide a stable supply for mass dog vaccination campaigns and stimulate expanded control of dog-mediated rabies in surrounding areas. (...) The vaccine bank allows countries to gain first-hand experience in mass dog vaccination, increase access to vaccines and improve data on the size of canine populations.
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Score: 1721071.9 - https://www.who.int/news/item/...ted-vaccine-bank-kwazulu-natal
Data Source: un
Rabies  is a preventable viral disease  that  is mainly  transmitted  to humans  through  the bite of an  infected dog.  Once  symptoms develop,  the disease  is  invariably  fatal  in humans unless  they promptly  receive post‐exposure  prophylaxis. Human rabies has been successfully prevented and controlled  in North America and  in a number of  Asian  and  Latin  American  countries  by  implementing  sustained  dog  vaccination  campaigns,  managing  dog  populations humanely and providing post‐exposure prophylaxis.  (...) Humans  become  infected  by  ingesting  Echinococcus  eggs  that  are  most  commonly shed in faeces of dogs and several wild canids, such as foxes, wolves, jackals and coyotes. 
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Score: 1600648.4 - https://www.who.int/neglected_diseases/Cheat_sheet_NTDs.pdf
Data Source: un
Page 1 No. 85/PMO 31/05/1993 (Unofficial Translation) DECREE ON LIVESTOCK MANAGEMENT IN LAO PDR Chapter I General Provisions Article 1 All species of domestic animals, including cattle, buffaloes, elephants, horses, donkeys, sheep, goats, pigs, dogs, cats, poultry, domesticated wildlife and fish in the territories of the Lao PDR should be under the centralized and unanimous legal management of the state, entrusted by the relevant sector of the State (Livestock and Fisheries sector) for implementation. The Government applies a policy of promotion for the progressive development of the livestock population in order to:  Meet food security and provide sufficient draught power in the country.  To serve as market oriented production and generate income for people and for all economic sectors as well.  To promote the improvement of animal breeds and the conservation of local breeds.  To manage the balance of the animal herds. (...) Article 5 The import and export of animal breeds, livestock and livestock products from the Lao PDR should be approved by the Ministry of Commerce based on the animal herd equilibration plan outlined by the Ministry of Agriculture and Forestry by following the general principles: Page 2 No. 85/PMO 31/05/1993 (Unofficial Translation) 5.1 For the exportation of animal breeds, livestock and livestock products, an export license shall be requested.
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Score: 1597271.3 - https://www.wto.org/english/th...e/lao_e/WTACCLAO3A1_LEG_15.pdf
Data Source: un
STATEMENT / SUBMITTED BY SIRIUS GLOBAL ANIMAL ORGANISATION CHARITABLE TRUST
Thailand has also cracked down on the illegal trade in dogs to neighbouring Viet Nam. It is sometimes claimed that dogs are a source of protein for the poor. (...) The World Health Organization has pointed out an alarming increase in the incidence of antibiotic-resistant strains of salmonella as a result of the use of antibiotics in intensive breeding. The fact that antimicrobial resistance is so prevalent is of extreme importance in the consumption of all animals, especially dogs. (...) Dogs are companion animals that serve humankind well.
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Score: 1577974.8 - daccess-ods.un.org/acce...?open&DS=E/2012/NGO/108&Lang=E
Data Source: ods
LETTER DATED 16 FEBRUARY 1979 FROM THE PERMANENT REPRESENTATIVE OF TURKEY TO THE UNITED NATIONS ADDRESSED TO THE SECRETARY-GENERAL
But let us not forget that :%ll dogs are of the same species. There are house dogs, ball-dogs; be? dogs, retriever dogs, etc. . . . Despite difference in breeds, dogs cannot escape beine dogs. (...) ; no matter how much you take care of them, they are still dogs! Turks are the same. BeCaUSe , you wash them, you clean them but they still smell as dogs.
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Score: 1568582.4 - daccess-ods.un.org/acce...nsf/get?open&DS=A/34/97&Lang=E
Data Source: ods
Pets Animals kept in houses such as the cats, dogs, and ornamental birds e.g. parrots, peacocks and ornamental fish. (...) (Three) In the case of the dogs which are less than 30 days of age they shall be vaccinated against the distemper, lepto spirosis, hepatitis and typhus. (...) (Five) The semen of the dogs and cats shall be from countries free from rabies disease.
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Score: 1514604.7 - https://www.wto.org/english/th...c_e/omn_e/WTACCOMN23_LEG_3.pdf
Data Source: un
Pets Animals kept in houses such as the cats, dogs, and ornamental birds e.g. parrots, peacocks and ornamental fish. (...) ARTICLE (5.4.1.4):  Equidae ARTICLE (5.4.1.5):  Dogs and cats )One( The exporting country of the animals shall be free from rabies disease. )Two( It shall be vaccinated against rabies disease within a period not to exceed six months from the date of the shipment or to be vaccinated on arrival at the account of the owner. )Three( In the case of the dogs which are less than 30 days of age they shall be vaccinated against the distemper, lepto spirosis, hepatitis and typhus. )Four( The cats less than 30 days of age shall be vaccinated against feline enteritis, feline trichitis and feline calsiroes. )Five( All the previous items shall be indicated in the veterinary health certificate accompanying the animal ARTICLE (5.4.1.6):  Birds and ornamental birds: )One( They shall be imported from countries or region free from all birds diseases mentioned in list “A” as per (OIE) classification. )Two( The birds shall be free from the diseases mentioned in list “B” of (OIE) classification. )Three( On importing ostrich and other wild birds, they shall be from countries free from Crimean Congo Hemorrhagic Fever. (...) ARTICLE (5.4.1.13): Semen and Embryos: )One( They shall be from a collection centre approved by the exporting country. )Two( The source animals shall be free from the infectious and contagious venereal diseases as per the classification lists “A” and “B” of (OIE). )Three( It shall be from countries free from the infectious and contagious diseases mentioned in list “A”. )Four( The source animals shall be free from any genetical diseases. )Five( The semen of the dogs and cats shall be from countries free from rabies disease.
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Score: 1514604.7 - https://www.wto.org/english/th...e/omn_e/WTACCOMN25A1_LEG_1.pdf
Data Source: un