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%
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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.
Language:English
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.
Language:English
Score: 1799006.8
-
https://www.who.int/mongolia/n...-day-2013-observed-in-mongolia
Data Source: un
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.
Language:English
Score: 1786020.7
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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.
Language:English
Score: 1721071.9
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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.
Language:English
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.
Language:English
Score: 1597271.3
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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.
Language:English
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.
Language:English
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.
Language:English
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.
Language:English
Score: 1514604.7
-
https://www.wto.org/english/th...e/omn_e/WTACCOMN25A1_LEG_1.pdf
Data Source: un
