OVERLAND PARK, Kan., June 5 Fort-Dodge-Animal
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 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 www.proheart6dvm.com or call 1-800-533-8536.
SOURCE Fort Dodge Animal Health
