View Full Version : EPA Approves Fort Dodge Animal Health's ProMeris For Dogs

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09-30-2007, 11:14 AM
Fort Dodge Animal Health, a division of Wyeth (NYSE: WYE), today announced the Environmental Protection Agency (EPA) has approved ProMeris™ for dogs, a low-volume, topical spot-on, to effectively control existing flea and tick infestations and prevent re-infestations on dogs and puppies eight weeks and older. ProMeris for cats, a topical spot-on for the effective control of existing flea infestations and to prevent re-infestation on cats and kittens eight weeks and older, was introduced in June 2007.

"The new ProMeris line gives veterinarians and pet owners a new weapon to fight today's fleas and ticks, which can be vectors of serious disease and health conditions," says Rami Cobb, BVSc (Hons), MACVSc, Senior Vice President of Pharmaceutical Research and Development, Fort Dodge Animal Health. "Metaflumizone has never before been used to control fleas and research shows they are readily susceptible. Amitraz, the second active ingredient in ProMeris for dogs, is a well-established tickicide and provides dogs with up to four weeks of tick control. Amitraz works by disrupting the tick's normal nerve function, leading to reduced feeding and attachment, paralysis and death of the tick."

ProMeris for dogs is the only product available to control fleas that contains the active ingredient metaflumizone, a new compound in the animal health industry. Its new mode of action attacks fleas' nervous systems by blocking voltage dependent sodium channels, which results in paralysis and death of the flea.

While monthly application is generally recommended for optimal flea and tick control, research results show ProMeris for dogs effectively controls fleas and protects against re-infestation for up to six weeks, and may be used as part of a treatment strategy for dogs suffering from flea allergy dermatitis.

ProMeris for dogs also provides broad-spectrum control of ticks including the Blacklegged Tick (Ixodes scapularis), Brown Dog Tick (Rhipicephalus sanguineus), American Dog Tick (Dermacentor variabilis) and Lone Star Tick (Amblyomma americanum), which can transmit serious diseases including Lyme disease, Rocky Mountain spotted fever and Ehrlichiosis.

ProMeris for dogs is waterproof and gentle enough to be used on dogs and puppies eight weeks and older. It is available in five sizes to accurately dose dogs and puppies of different body weights. Each size is available in three- or six-dose packages. ProMeris for dogs will be available for sale to veterinarians in the fall of 2007.

ProMeris for Dogs Available Exclusively From Veterinarians

ProMeris for dogs is only available through practicing veterinarians involved in an established veterinarian-client-patient relationship. Fort Dodge established a veterinarian-only sales policy for ProMeris for dogs because it believes veterinarians should be pet owners' primary source of information to help ensure the health and well-being of their companion animals. Fort Dodge will not sell ProMeris for dogs through over-the-counter (OTC) channels, including Internet pharmacies.

Fort Dodge has created a Track and Trace system, a proprietary technology to help ensure ProMeris for dogs will only be available from veterinarians. Track and Trace features a barcode tracking system, which monitors the movement of each individual dose of ProMeris for dogs from manufacture to the individual veterinary practice that purchases the product. With the Track and Trace system, any product found in the OTC channel can be traced back to the purchasing customer.

User-Friendly Applicator Design

Fort Dodge devoted considerable time to the design of the packaging for ProMeris for dogs to make it easy to use for pet owners. One of the advanced packaging features includes a novel nozzle design that helps minimize "splash back" and helps prevent the dose from spilling out, even when inverted, until the pet owner is ready to apply the product. Label information, such as species, size and weight range, is printed on every applicator for accurate dosing. The rounded applicator nozzle reduces the risk of skin abrasions during product application.

About Fleas

Fleas can be a severe nuisance and irritation to pets and humans. They may also cause illness including anemia and flea allergy dermatitis, transmit Murine Typhus and Cat Scratch Disease, and serve as an intermediate host of parasites. Adult cat fleas begin feeding almost immediately once they acquire a host (i.e., pet). Mating occurs after fleas have fed and egg production begins about 24 hours after females take their first blood meal. Females are capable of producing 40 to 50 eggs per day during peak production and can produce eggs for more than 100 days. With such a large reproductive output, most homes would rapidly become infested with hundreds or even thousands of fleas.

About Ticks

Many of the ticks that infest dogs and cats will also affect humans. Ticks can carry and transmit a broad range of bacterial and protozoal diseases, including Lyme disease, Rocky Mountain spotted fever and Ehrlichiosis. Ticks transmit disease effectively because they attach firmly when feeding and may go unnoticed for some time, as feeding may take several days to complete. Mating usually occurs while adult ticks are on the body of the host animal. The female then drops to the ground and deposits her eggs. Adult female hard ticks feed only once and lay one large batch of eggs, which may contain 10,000 or more. Some of the more common ticks include the American Dog Tick (Dermacentor variabilis), Lone Star Tick (Amblyomma americanum), Blacklegged Tick, also known as the Deer Tick (Ixodes scapularis) and Brown Dog Tick (Rhipicephalus sanguineus).

About Fort Dodge Animal Health

Fort Dodge Animal Health is a leading manufacturer and distributor of animal health products for the companion animal, equine, livestock, swine and poultry industries in North America and international markets. Key products include West Nile-Innovator® and the Innovator® combination vaccines, the line of Duramune® vaccines, the Fel-O-Vax® vaccine line, CYDECTIN® Pour-on, the Pyramid® vaccine line and QUEST® Gel.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and 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 risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third-party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, 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." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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