OVERLAND PARK, Kan., June 5 /PRNewswire/ -- Fort Dodge Animal Health, a
division of Wyeth (NYSE: WYE), today announced the reintroduction of
ProHeart(R) 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.
Veterinarians who wish to purchase ProHeart 6 will be required to
participate 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 http://www.vetsymposium.com/proheart6 and follow the
directions provided on the site. If a veterinarian is unable to attend the
Web-based session, the training program will also be continuously available
on the Web site noted above beginning Friday, June 13. This training and
registration must be completed before product will be shipped to a
practitioner. For additional information, veterinarians are encouraged to
call their Fort Dodge sales representative or call the Company's
Professional Services department at 1-800-533-8536.
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(R), CYDECTIN(R) Pour-On, the
Duramune(R) and Fel-O-Vax(R) vaccine lines, and QUEST(R) and QUEST(R) 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 February 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(R) 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://www.proheart6dvm.com or call 1-800-533-8536.
SOURCE Fort Dodge Animal Health
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Related links:
http://www.vetsymposium.com/proheart6
http://www.proheart6dvm.com http://www.wyeth.com
CONTACT:
Kelly Goss of Fort Dodge Animal Health,
+1-913-664-7276, +1-913-375-4434, cell, gossk@fdah.com; or Doug
Petkus of Wyeth, +1-973-660-5218, petkusd@wyeth.com, or Justin
Victoria of Wyeth Investor Relations, +1-973-660-5340,
victorj@wyeth.com
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