Novartis bolsters innovative dermatology portfolio through acquisition of Ziarco Group Limited

NovartisNovartis announced today that it has entered into a definitive agreement for the acquisition of Ziarco Group Limited, a privately held company focused on the development of novel treatments in dermatology. This acquisition would add a once-daily oral H4 receptor antagonist in development for atopic dermatitis (AD), commonly known as eczema, to complement the growing Novartis dermatology portfolio and pipeline. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.

Ziarco's lead investigational product, ZPL389, is a potential first-in-class oral treatment for moderate-to-severe eczema. Eczema is a chronic, itchy, inflammatory skin condition found in millions of children and adults worldwide[1]. In addition, it is associated with sleep loss and a significant reduction in quality of life[2]. Currently, no safe, effective, and well-tolerated oral treatments are available for the moderate-to-severe form of this condition.

"There is an unmet need for innovative, effective and safe oral treatment options for people living with eczema," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We are proud of our dermatology capabilities shown by the recent successful launches of Cosentyx and Xolair. Now we're excited about a potential new medicine for people with eczema through the acquisition of Ziarco and the addition of a first-in-class oral H4 receptor antagonist to our growing pipeline."

In a proof of concept study, ZPL389 showed a clinically and statistically significant reduction of eczema. After eight weeks of treatment, the compound reduced the Eczema Area and Severity Index (EASI) score by 50% (placebo: 27%, (p=0.01)) in a study of 98 patients. In addition, there was a statistically significant improvement in SCORing Atopic Dermatitis (SCORAD) and body surface area (BSA) scores affected by eczema for ZPL389. The study also showed a decrease in itching, which was numerically greater in the active treatment arm. Both the EASI and SCORAD sub-scores related to itching showed positive results and there was a statistically significant decrease in sleep loss for the active comparator. Itch is a major cause for sleep loss in eczema patients[2]. In clinical studies conducted to date, ZPL389 has a favorable safety profile.

Eczema poses a significant burden on health-care resources and patients' quality of life with recent data showing that its prevalence is still increasing[3]. Eczema affects up to 10% of the population in the US alone[4],[5], with approximately 15% of children and 70% of adults having the moderate-to-severe form of the disease[6]. Treatment does not cure eczema but can control symptoms and potentially improve quality of life[7].

About the Novartis dermatology portfolio
Novartis is committed to addressing the unmet medical needs of patients living with dermatological conditions and improving their overall quality of life by providing innovative medicines. The Novartis Dermatology portfolio includes Cosentyx (secukinumab) for the treatment of moderate-to-severe psoriasis and Xolair (omalizumab) for the treatment of chronic spontaneous urticaria.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world.

1. Bieber T. Atopic Dermatitis. N Engl J Med. 2008;358:1483-1494
2. Patel T. et al. Nocturnal Itch: Why do we itch at night? Acta Derm Venereol. 2007;87:295-298
3. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab. 2015;66(suppl 1):8-16
4. Silverberg et al. Adult eczema prevalence and associations with asthma and other health and demographic factors: A US population-based study. J Allergy Clin Immunol. 2013; 132 (5): 1132-1138.
5. Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema Prevalence in the United States: Data from the 2003 National Survey of Children's Health. J. Invest. Dermatol. 2001; 131:67-73.
6. Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.
7. American Academy of Dermatology (AAD) website. Atopic Dermatitis. Available at: https://www.aad.org/public/diseases/eczema/atopic-dermatitis#treatment. Last accessed December 2016

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