ProHeart 6 Safety Assessment by Fort Dodge Animal Health
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1 ProHeart 6 Safety Assessment by Fort Dodge Animal Health January 31, 2005
2 Rami Cobb, BVSc (Hons.) MACVSc Vice President Pharmaceutical Research & Development Fort Dodge Animal Health
3 ProHeart 6 Introduction Active ingredient: moxidectin Macrocyclic lactone Anthelmintic agent Dogs, horses, cattle, sheep, swine Co-development with WHO for humans Onchocerciasis (river blindness)
4 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
5 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
6 Pre-Approval ProHeart 6 Clinical Study Results 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
7 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
8 ProHeart 6 Approval Approved and marketed globally US June 2001 Canada, Japan, Italy, France, Spain, Portugal, Greece, Korea ProHeart SR 12 Australia October months heartworm protection 3 times ProHeart 6 dose
9 ProHeart 6 Market Experience Rapid and broad acceptance by dog owners and veterinary professionals 24% US market share 47% Australian market share
10 Brand Share Change Dispensed Units 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% Q Q Q Q Q Q Q Q Q Q Q Q % Heartgard Heartgard Plus Interceptor Iverhart Plus ProHeart 6 Revolution Sentinel Source: June 2004 Doane Market Research: Heartworm Tracking Study
11 ProHeart 12 - Australia 50.00% 45.00% 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Canimax/ Heart Exelpet Heartgard Chew Heartgard Plus Heartgard Tabs Proheart SR12 Proheart Tabs Revolution Advantage& Advocate Interceptor Sentinal/ Plus Mar-02 Jun-02 Sep-02 Dec-02 Mar-03 Jun-03 Sep-03 Dec-03 Mar-04 Jun-04 Sep-04
12 US and Australian AER Reports US Australia Doses sold 18,000,000 2,000,000 AER rate (per 10,000 doses) Allergy reporting rate (per 10,000 doses) Death reporting rate (per 10,000 doses)
13 ProHeart 6 Introduction 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
14 ProHeart 6 Epidemiological Evaluation (presented by Dr. Larry Glickman, Purdue University) 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
15 Re-Evaluation of AERs by FDAH (presented by Dr. David Hustead, FDAH) 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
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