Fort Dodge Reintroduces ProHeart 6 to U.S. Market
Fort Dodge recently announced the reintroduction of ProHeart® 6, a unique heartworm preventative, to the U.S. veterinary market. This announcement follows a review by the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) of an extensive body of scientific data and international experience, which support the decision to return this life-saving product to the market.
"We are extremely pleased to bring ProHeart 6 back to veterinarians and pet owners throughout the United States, as it has safely and effectively protected millions of dogs around the world against potentially deadly heartworm disease," says Rami Cobb, BVSc (Hons), MACVSc, senior vice president of pharmaceutical research and development for Fort Dodge Animal Health. "Our first and foremost priority continues to be providing products that help ensure the health and well being of all animals.
"At the time of the voluntary U.S. recall in 2004, we believed it was in the best interest of veterinarians and pet owners to thoroughly address the concerns of the CVM before continuing the marketing of this product in the United States. We have always maintained our confidence in ProHeart 6 and the unique medical benefits it brings to veterinary medicine. Fort Dodge has worked with the CVM to address its questions, and feels the scientific data, as well as our vast experience with the product internationally, supports confidence in the product and its return to the U.S. market."
For the past seven years, Fort Dodge has provided the ProHeart family of sustained-release products in a number of other countries, where it has protected millions of dogs against this potential deadly disease. It is marketed in major countries (Australia, the Mediterranean regions of Europe and Japan) where heartworm infection is endemic and a serious health risk for dogs. ProHeart products have achieved substantial usage in all of these countries, and are the market leader in both Australia and Italy.
ProHeart 6 is the only option for heartworm prevention in the United States that helps ensure dogs are continuously protected against this potentially fatal disease for six months following a single dose. The American Heartworm Society (AHS) estimates as many as 27 million dogs in the United States are not currently on a preventative – putting a staggering number of dogs at risk for heartworm disease. Based on a survey conducted by the AHS in 2005, the organization also reports approximately 250,000 pets in the United States tested positive for heartworm infection in 2004, which represents an increase of nearly 5 percent over the number of pets that tested positive in 2001.
Because ProHeart 6 is being returned to the U.S. veterinary market following a voluntary recall, Fort Dodge will implement a post-marketing surveillance initiative based on programs used to monitor the safety of human drugs. The effort will include comprehensive veterinarian training, pet owner education and consent forms, and specific requirements for the purchase and administration of ProHeart 6. This program will also allow the Company to gather additional product data and maintain active communication with veterinarians and the CVM.
Practitioners who purchase ProHeart 6 will also be required to communicate with pet owners about the benefits and risks associated with the product. This will include providing pet owners with a Client Information Sheet and answering all client questions, as well as obtaining a signed "Informed Consent" form from the pet owner before the product is administered.
"While Fort Dodge and other veterinary professionals have worked diligently during the past few years to generate additional safety data to support the return of ProHeart 6 to the U.S. market, this accomplishment would not have been possible without the support of countless veterinarians and pet owners who truly believe in this product and recognize the benefits it brings to the dogs in our lives," says Dr. Cobb.
Fort Dodge Animal Health is a leading manufacturer and marketer of animal health products for the livestock, companion animal, equine, swine and poultry industries in North America and international markets. Key products include West Nile-Innovator®, CYDECTIN® Pour-On, the Duramune® and Fel-O-Vax® vaccine lines, and QUEST® and QUEST® Plus Gel. The company has research and development facilities in Iowa and New Jersey, and manufacturing facilities/offices in Brazil, Argentina, Spain, Ireland, France, The Netherlands, Italy, India, Taiwan and Australia. Its headquarters is in Overland Park, Kan.
About Heartworm Disease
Heartworm disease is a potentially deadly disease affecting the U.S. canine population. Spread by mosquitoes, it can cause serious damage to the heart and pulmonary arteries eventually leading to heart failure. In severe cases, heartworm disease can damage other organs such as the liver and kidneys. Clinical signs of heartworm disease may not be recognized in the early stages, as heartworms may accumulate gradually over a period of months and sometimes years. Heavily infected animals may show clinical signs including mild, persistent cough, reluctance to move or exercise, tiredness after only moderate exercise, reduced appetite and weight loss. Prevention of heartworm disease is the best alternative, as treatment can result in death, severe allergic reactions or pulmonary embolism.
The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on Februa ry 29, 2008. The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
ProHeart® 6 is generally well tolerated. Do not use in sick, debilitated or underweight animals, animals with a history of weight loss, or within one month of vaccination. Use with caution in dogs with pre-existing allergic disease. A small percentage of dogs showed mild, transient swelling or itching at the injection site. While rare, allergic, digestive, hematological, or neurological reactions may occur. In addition, death has been reported. ProHeart 6 is available only through a restricted distribution program. Only veterinarians enrolled in this program can receive and administer ProHeart 6. In addition, ProHeart 6 must only be administered to clients whose owners have been advised of the risks of ProHeart 6 and sign an Owner Consent Form. To obtain additional information including a copy of the product labeling, visit the website at http://ac.acidirect.net/c.asp?709669&1744501031ab3d03&4 or call 1-800-533-8536.