United States

Zoetis Receives USDA License for CYTOPOINT

  • 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. – Dec. 21,2016 – 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 7-561, 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. For full Prescribing Information, go to ZoetisUS.com/ApoquelPI.

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

References:
* 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.

For further information contact:
Colleen White
973-822-7203 (o)
colleen.white@zoetis.com

Media Contacts:
Elinore White
973-443-2835 (o)
elinore.y.white@zoetis.com

Investor Contact:
Steve Frank 
973.822.7141 (o)
steve.frank@zoetis.com