Bayer to Expand Companion Animal Portfolio With Two New EU Product Approvals

MONHEIM, Germany, April 26, 2011 /PRNewswire/ -- Bayer today announced that the European Commission has approved two new companion animal products: Veraflox(R) (pradofloxacin) and Procox(R) (emodepside and toltrazuril). Veraflox(R) is the first next-generation veterinary fluoroquinolone antibiotic for the treatment of bacterial infection in cats and dogs. Procox(R) is the first and only licensed combination treatment for roundworm and coccidia in dogs.

"Bayer Animal Health is proud to introduce these two innovative treatments which will provide veterinarians with much needed, effective new treatment options for a range of indications," said Jean-Luc Lowinski, Managing Director of Bayer Animal Health. "As an expert solution provider for animal health we have a strong and ongoing commitment to researching and developing innovative ways to address parasitic and bacterial infections in companion animals."

Veterinary antibiotics such as fluoroquinolones are an essential weapon in the fight against infections in companion animals worldwide. There have, however, been no major advances in the class since the introduction of the first veterinary fluoroquinolone by Bayer Animal Health over 20 years ago.

Veraflox(R) is the first next-generation veterinary fluoroquinolone antibiotic for the treatment of bacterial infection in cats and dogs and marks the first major advance in the fluoroquinolone market in many years. Veraflox(R)'s mode of action gives it enhanced antibacterial activity compared with existing fluoroquinolones, including extended spectrum efficacy against Gram-positive and anaerobic pathogens. The European Commission granted approval for the treatment of the following infections caused by specified and susceptible pathogens: wound infections, superficial and deep pyoderma (bacterial skin infections), acute urinary tract infections, and, as adjunctive treatment for severe gingival (gum) and periodontal tissue infections in dogs, and against wound infections, abscesses and acute upper respiratory tract infections in cats (oral suspension). Veraflox is approved in 30 European countries and will be launched in the first markets shortly.

Procox(R) is the first parasiticide of its kind for the combination treatment of roundworm and coccidia gastrointestinal parasitic infections in dogs, including puppies of at least two weeks of age and weighing at least 0.4 kg. This is important as puppies are extremely susceptible to parasitic infections in their early months. Roundworms are often transmitted from the mother to the newborn, and coccidia frequently occur during the first month of life. Due to its single dose suspension formulation, which can be taken from two weeks of age, Procox(R) offers an easy and convenient first time treatment option for puppies.

Procox(R) is approved in 27 EU countries and the first launches are planned for quarter 3, 2011.

About Veraflox(R)

Veraflox(R) has proven outstanding efficacy across a range of infections in both cats and dogs. Veraflox(R) is safe and well tolerated at the recommended therapeutic dose. In field studies of over 700 dogs and cats, all adverse events with Veraflox(R) treatment were mild and transient and comparable to the control group. Extensive ocular safety testing has demonstrated that Veraflox(R) has no adverse effects on feline retinas, even at ten times the recommend therapeutic dose. Veraflox(R) is palatable with simple once daily formulations - flavoured tablets for dogs and cats and a convenient oral suspension for cats - helping facilitate compliance whilst giving veterinarians optimal and flexible control over infections. Unlike long-acting injectable antibiotics, veterinarians are able to fully control treatment duration with Veraflox(R) as it is administered daily.

About Procox(R)

Procox(R) is the first parasiticide of its kind for the combination treatment of roundworm and coccidia gastrointestinal parasitic infections in dogs. It treats infections with adult, immature adult and larval stages of Toxocara canis and adult stages of Uncinaria stenocephala and Ancylostoma caninum. In addition Procox(R) is effective against the replication of coccidia and also against the shedding of oocysts, thereby reducing the spread of infection. Procox(R) is available in an easy and convenient oral suspension. One administration is generally sufficient though it can be given every two weeks, on up to five occasions if required.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at http://www.bayerhealthcare.com.

With a turnover of EUR 1.120 million (2010) Bayer HealthCare's Animal Health Division is one of the world's leading manufacturers of veterinary drugs. The division manufactures and markets more than 100 different veterinary drugs and care products for livestock and companion animals.

Find more information at http://www.animalhealth.bayerhealthcare.com.

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