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"We are extremely pleased to bring ProHeart 6 back to veterinarians andpet owners throughout the United States, as it has safely and effectivelyprotected millions of dogs around the world against potentially deadlyheartworm disease," says Rami Cobb, BVSc (Hons), MACVSc, senior vice presidentof pharmaceutical research and development for Fort Dodge Animal Health. "Ourfirst and foremost priority continues to be providing products that helpensure the health and well being of all animals.
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"At the time of the voluntary U.S. recall in 2004, we believed it was inthe best interest of veterinarians and pet owners to thoroughly address theconcerns of the CVM before continuing the marketing of this product in theUnited States. We have always maintained our confidence in ProHeart 6 and theunique medical benefits it brings to veterinary medicine. Fort Dodge hasworked with the CVM to address its questions, and feels the scientific data,as well as our vast experience with the product internationally, supportsconfidence in the product and its return to the U.S. market."
For the past seven years, Fort Dodge has provided the ProHeart family ofsustained-release products in a number of other countries, where it hasprotected millions of dogs against this potential deadly disease. It ismarketed in major countries (Australia, the Mediterranean regions of Europeand Japan) where heartworm infection is endemic and a serious health risk fordogs. ProHeart products have achieved substantial usage in all of thesecountries, and are the market leader in both Australia and Italy.
ProHeart 6 is the only option for heartworm prevention in the UnitedStates that helps ensure dogs are continuously protected against thispotentially fatal disease for six months following a single dose. The AmericanHeartworm Society (AHS) estimates as many as 27 million dogs in the UnitedStates are not currently on a preventative -- putting a staggering number ofdogs at risk for heartworm disease. Based on a survey conducted by the AHS in2005, the organization also reports approximately 250,000 pets in the UnitedStates tested positive for heartworm infection in 2004, which represents anincrease of nearly 5 percent over the number of pets that tested positive in2001.
Because ProHeart 6 is being returned to the U.S. veterinary marketfollowing a voluntary recall, Fort Dodge will implement a post-marketingsurveillance initiative based on programs used to monitor the safety of humandrugs. The effort will include comprehensive veterinarian training, pet ownereducation and consent forms, and specific requirements for the purchase andadministration of ProHeart 6. This program will also allow the Company togather additional product data and maintain active communication withveterinarians and the CVM.
Veterinarians who wish to purchase ProHeart 6 will be required toparticipate in a Web-based training program scheduled for Thursday, June 12,at 1 p.m. EDT and register with Fort Dodge Animal Health. To register,veterinarians should go to www.vetsymposium.com/proheart6 and follow thedirections provided on the site. If a veterinarian is unable to attend theWeb-based session, the training program will also be continuously available onthe Web site noted above beginning Friday, June 13. This training andregistration must be completed before product will be shipped to apractitioner. For additional information, veterinarians are encouraged to c
