Zoetis Receives USDA License for CYTOPOINT™

December 21, 2016 Source: Zoetis

  • First monoclonal antibody licensed to help control the clinical signs associated with atopic dermatitis in dogs
  • Targets and neutralizes interleukin-31 (IL-31), a key itch-inducing cytokine (protein) in canine atopic dermatitis
  • Provides convenience and long-lasting relief from itch with one injection every four to eight weeks
  • Joins Zoetis’ APOQUEL ® (oclacitinib tablet), giving the company two targeted treatment options to offer veterinarians for canine patients with atopic dermatitis

PARSIPPANY, N.J.–(BUSINESS WIRE)–Zoetis Inc. (NYSE:ZTS) today announced that the U.S. Department of Agriculture (USDA) has granted the company a license for CYTOPOINT™, the first monoclonal antibody (mAb) therapy approved to help provide sustained control of the clinical signs associated with atopic dermatitis in dogs. CYTOPOINT targets and neutralizes interleukin-31 (IL-31), a key protein involved in triggering itch in dogs. It provides fast, effective relief of itching – the hallmark sign of the allergic skin condition atopic dermatitis in dogs – and offers the sustained efficacy and convenience of one injection every four to eight weeks. CYTOPOINT helps improve the long-term quality of life for dogs suffering from atopic dermatitis and eases the related frustration and concern of their owners. It is now available to all veterinarians in the United States

“As the owner of allergic pets, I understand the frustration that my clients feel, and as a person with allergies myself, I understand what my patients feel,” said Laura Stokking, PhD, DVM, DACVD, Veterinary Specialty Hospital, San Diego, CA.* “With CYTOPOINT, in a single injection we now have an excellent opportunity to help control the itch without leading to any secondary signs that can be more difficult to manage than the itch itself.”

“CYTOPOINT results from our acquiring a deeper scientific understanding of the causes of allergic skin conditions in dogs at the molecular level and developing novel, targeted, effective treatments based on these new insights,” said Dr. Catherine Knupp, Executive Vice President and President, Research and Development at Zoetis. “Veterinarians have told us that allergic dogs and their owners have a variety of needs and we are proud to offer them two innovative solutions with CYTOPOINT and with our oral tablet therapy APOQUEL. These first-in-class medicines give veterinarians effective, safe options to customize atopic dermatitis treatment for canine patients, and I am very proud of the breakthrough treatments our Zoetis team has developed.”

APOQUEL® (oclacitinib tablet) is the first Janus kinase inhibitor approved by the U.S. Food and Drug Administration for veterinary use to provide fast and safe itch relief for dogs at least 12 months of age that have symptoms associated with allergic dermatitis triggered by food, fleas or contact allergens, as well as atopic dermatitis.

About CYTOPOINT

CYTOPOINT is a ready-to-use, sterile liquid injectable containing a mAb specifically designed to target and neutralize cytokine interleukin-31 (IL-31), a key cytokine (protein important in cell-to-cell communication) involved in triggering the itch associated with canine atopic dermatitis. It works by mimicking the activity of natural antibodies to selectively bind and neutralize IL-31, thus interrupting the itch cycle in atopic dogs.

CYTOPOINT begins working within 1 day and delivers 4 to 8 weeks of relief from the clinical signs of canine atopic dermatitis, allowing the damaged skin the chance to heal. In clinical studies submitted to the USDA and published in Veterinary Dermatology, treatment with CYTOPOINT at a minimum dose of 2 mg/kg resulted in a significantly (P≤0.05) greater percentage reduction from baseline in pruritus on days 1–49, and skin condition scores on days 7-56(1), when compared to placebo.

It is safe for dogs of any age, even those with concomitant diseases, and can be used with many common medications. Moreover, because of its specificity in targeting IL-31, it has minimal impact on normal immune responses.

The USDA granted Zoetis a conditional license for Canine Atopic Dermatitis Immunotherapeutic (now branded as CYTOPOINT) in August 2015. During the conditional licensing period, Zoetis collected valuable feedback from dermatology specialists, a small group of general practice veterinarians, and pet owners to prepare for full licensure.

About Atopic Dermatitis

Itching is among the most frequent complaints of pet owners, affecting roughly 1 in 6 dogs whose owners seek veterinary help(2). There are a number of factors that can trigger an itch reaction, such as infections, allergies and parasites—and approximately 15-20 percent of all itchy dogs will be diagnosed with atopic dermatitis(2).

CYTOPOINT is now available for veterinarians throughout the United States. It brings mAb therapy – a fast-growing area of human medicine – for the first time to veterinarians for use to treat atopic dermatitis in canine patients. For more information, visit www.cytopoint.com.

IMPORTANT SAFETY INFORMATION ABOUT APOQUEL

Do not use APOQUEL in dogs less than 12 months of age or those with serious infections. APOQUEL may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. APOQUEL has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL has been used safely with many common medications including parasiticides, antibiotics and vaccines….

About Zoetis

Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products and genetic tests and supported by a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. In 2015, the company generated annual revenue of $4.8 billion with approximately 9,000 employees. For more information, visit www.zoetis.com.

Forward-Looking Statements : This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to business plans or prospects, future operating or financial performance, future guidance, future operating models, expectations regarding newly approved products and other products and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov , www.zoetis.com , or on request from Zoetis.

* Dr. Laura Stokking has a consulting relationship with Zoetis.

1 Data on file, Study Report No. C863R-US-12-018, Zoetis LLC.

2 Data on file, IL-31 Positioning Research. IPSOS 2014. L-31 Pricing Research. SKP. 2015, Zoetis LLC.

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Malassezia (Yeast) Dermatitis by Judy Seltzer, BVetMed, MRCVS, DACVD

Background
Malassezia dermatitis and otitis occurs most commonly in animals with allergies, endocrinopathies (hypothyroidism, Cushing’s disease), immunosuppressive diseases and other skin diseases. The most common causative organism is Malassezia pachydermatis. It is normal to find a small number of these organisms on cats, dogs and even people. However, overpopulation is common when the normal skin barrier is compromised.

Dogs of any age, breed, or gender can be affected by yeast dermatitis. Predisposing skin factors for Malassezia include warmth, moisture, increased humidity, exaggerated skin folds, obesity and inflamed skin or ears. Commonly affected breeds include West Highland White Terriers, Basset Hounds, Cocker Spaniels, Springer Spaniels, and Chinese Shar Peis. Other conditions that can be associated with secondary yeast infections include endocrinopathies (hypothyroidism, hyperadrenocorticism) and immunosuppression (neoplasia, animals on chemotherapy). Although less common than in dogs, yeast dermatitis can occur in cats, especially in Persian cats or cats with underlying internal disease. Malassezia is not considered to be contagious to other animals or people; however there are very rare reports of immunocompromised humans being at greater risk of infection.

Clinical Signs
Yeast infections can be localized (ears, perianal region, facial skin folds, interdigital spaces) or have a more generalized presentation. Affected animals are often pruritic and may be found licking and chewing the affected sites. The degree of itching does not always correlate with the actual severity of the infection. Some animals have fewer numbers of yeast organisms present but suffer from a hypersensitivity to these organisms. The skin of affected animals is usually erythematous, may have yellow crusting and scaling, and can become hyperpigmented and lichenified over time. Areas of the body commonly affected in dogs include the feet, nails, underside of the neck, axillae, abdomen, legs and under the tail. In cats, yeast infections can involve the chin or face, nails, or occasionally elsewhere on the body.

Diagnosis
Malassezia is usually diagnosed by performing skin or ear cytology. Samples are taken by pressing a slide against the skin, using cotton swabs or acetate tape, or performing dry skin scrapings with a blade. After staining with Diff-Quik, the slide can be examined under the microscope at 1000x (under oil). A few yeast organisms (1-2 yeast organisms per microscopic field) found on the skin or ear are usually considered normal. However, a larger number of organisms in combination with erythema, irritation and pruritus is considered abnormal. Additionally, identification and treatment of the underlying cause of the yeast infection is very important, and other diagnostics may include trial therapy for scabies mites, a hypoallergenic diet trial, allergy testing, bloodwork for hormonal diseases, or skin biopsies.

Treatment
The treatment for Malassezia dermatitis usually involves topical therapy with antifungal shampoos, sprays, wipes and lotions and/or systemic treatments with ketoconazole, fluconazole, itraconazole or terbinafine. The use of topical products alone may be adequate for treating mild or localized infections. Oral medications are recommended for more severe or generalized infections. Some infections require long term therapy for the best results. Occasionally, pulse therapy (therapy used only certain days of the week) is necessary to treat patients with chronic yeast infections. Most animals will also require oral antibiotics for concurrent bacterial skin infections. Treatment of the underlying cause is also very important and may involve trial therapy for parasites, a hypoallergenic diet, allergy hyposensitization injections based on allergy testing, or therapy for any underlying hormonal or internal disease.

Prognosis
The prognosis for yeast dermatitis is good, as long as the underlying cause is identified and treated. Some animals are not cured, but controlled with intermittent topical or systemic anti-yeast therapy.

Judy Seltzer, BVetMed, MRCVS, DACVD
Veterinary Medical Center of Long Island
75 Sunrise Highway
West Islip, New York 11795
(631) 587-0800; fax (631) 587-2006

http://www.vmcli.com

posted 10/7/2017

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Dermatologic (skin issues allergies, parasites, etc.) Link Resources

Dog Allergies: Symptoms and Treatment
Anna Burke | August 24, 2017 | AKC Learn more

Pododermatitis in Dogs (Inflammation of paws)
By Tammy Hunter, DVM; Ernest Ward, DVM | VCA |  Learn more…

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