• Easy-to-dose oral solution developed specifically for cats offers first and only non-steroid therapy for allergic dermatitis¹
• Allergic dermatitis, which causes itching, scratching and licking with resulting skin lesions and loss of hair, is one of the most common reasons for cat veterinary visits ²
• Atopica for Cats is proven to significantly relieve itching and reduce skin lesions, with improvement seen within a few weeks

Greensboro, NC, August 12, 2011—Novartis Animal Health US, Inc. announced today that Atopica^®for Cats(cyclosporine oral solution, USP) MODIFIED, a treatment for chronic allergic dermatitis, has been approved by the FDA.  This disease, which is one of the most common reasons for pet owners to take cats to the veterinarian², can be difficult to diagnose and causes itching and associated chewing and licking, skin lesions and loss of hair.  With a similar product already approved and successfully used to treat atopic dermatitis in dogs, Atopica^®for Cats is the first medication approved in the US specifically for allergic dermatitis in cats.

Atopica for Cats provides relief from the uncomfortable and recurrent itch/scratch cycle, and the majority of improvement is seen in the first four weeks^3-5. After six weeks of treatment with Atopica for Cats, 78 percent of cats were considered “comfortable” with satisfactory levels of grooming³ – a key indicator of a healthy cat. Additionally, Atopica for Cats is proven to significantly reduce unsightly and painful skin lesions and has a proven safety profile.

“Veterinarians and pet owners understand the discomfort and frustration of an itchy pet,” said George Gunn, BVMS, MRCVS and Division Head of Novartis Animal Health and Head, Novartis Corporate Responsibility.  “We are pleased to add Atopica for Cats to our proven family of Atopica products, offering an effective treatment for cats suffering from the extreme discomfort associated with allergic dermatitis.”

Developed specifically for domestic felines, Atopica for Cats is an oral solution that is easy to dose and administer. In studies, approximately one-third of cats took the medicine in their food and two-thirds were dosed directly into the mouth^3,4. The product offers a unique mode of action that specifically targets immune cells such as the T-lymphocytes involved in the allergic reaction. In this way, Atopica for Cats blocks the production of inflammatory cytokines, molecules that fuel the allergic response, breaking the recurrent itch/scratch cycle.

“Atopica for Cats has the potential to change how our profession treats the itchy cat,” said Dr. Keith Hnilica, DVM, MS, MBA and DACVD, who consults with Novartis and others on dermatological issues, and author of Small Animal Dermatology: A Color Atlas and Therapeutic Guide (3^rd ed).  “For the first time ever, we have a safe, highly effective, approved treatment for cats with allergic dermatitis. And because Atopica for Cats is not a corticosteroid, I can prescribe it for long-term use without worrying about the health risks that can be associated with steroids.”

Atopica for Cats offers an advanced alternative to steroids, avoiding the potential health risks associated with corticosteroids, which in cats include marked cutaneous atrophy, skin fragility, congestive heart failure and increased susceptibility to diabetes mellitus⁶.

The US launch of Atopica for Cats will begin in late 2011 and continue through 2012.

About Atopica for Cats
Atopica for Cats is a new, non-steroid alternative for the symptomatic control of feline allergic dermatitis. It is an oral solution of cyclosporine that lowers the immune response. The medication selectively acts on the immune cells involved in the allergic reaction. As with all drugs, Atopica for Cats may cause some side effects in individual cats. The most common side effect reported in clinical trials was vomiting. In most cases, the vomiting resolved with continued use. Weight loss, diarrhea, decreased appetite, lethargy and drooling were the next most frequent side effects observed. Persistent, progressive weight loss may be associated with more serious side effects and resulted in hepatic lipidosis in two out of 205 cats treated with Atopica for Cats in field studies. Monitoring of body weight is recommended in cats receiving Atopica for Cats.

As Atopica for Cats is a systemic immunosuppressive drug, it may increase the susceptibility to infection and the development of neoplasia. Therefore cats with a history of cancer or cats that may have cancer currently should not take Atopica for Cats. Cats should be tested and found to be negative for FeLv and FIV infections before treatment. Cats that are seronegative for Toxoplasma gondiimay be at risk of developing clinical toxoplasmosis if they become infected while under treatment. In rare cases this can be fatal. Potential exposure of seronegative cats to Toxoplasma should be avoided (e.g. keep indoors, avoid raw meat and scavenging).

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” or similar expressions, or by express or implied discussions regarding potential future revenues from Atopica for Cats. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Atopica for Cats to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Atopica for Cats will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Atopica for Cats could be affected by, among other things, competition in general; government, industry and general public pricing pressures; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Animal Health US, Inc.
Headquartered in Greensboro, NC, Novartis Animal Health US, Inc. researches, develops and commercializes leading animal treatments that meet the needs of pet owners, farmers and veterinarians. Part of the Basel, Switzerland-based Novartis Animal Health global organization, the US business is the largest of the 40 countries where Novartis Animal Health operates.  For more information about Novartis Animal Health US, Inc., please consult http://www.ah.novartis.us.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group’s continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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*NADA #141-329, Approved by FDA

References

1.         Atopica for Cats is indicated for control of feline allergic dermatitis in the US.

2.         Veterinary Practice News, April 2011: Veterinary Pet Insurance (VPI), top 10 pet medical conditions of 2010, p10.

3.         Novartis data on file. Study summary CYCINT-0105.

4.         Novartis data on file. Study summary CYCINT-0205.

5.         Novartis data on file. Study summary NAH-07-0028.

6.         Lowe AD et al. Glucocorticoids in the cat. Vet Derm, 2008, 19, 340-347

Atopica is a registered trademark of Novartis AG. For further information, contact Novartis Animal Health US, Inc., Customer Relations Department, 3200 Northline Avenue, Ste. 300, Greensboro, NC 27408; 1-800-843-3386.

© 2011 Novartis Animal Health US, Inc.

Source: Novartis Animal Health US, Inc.