Novartis demonstrates commitment to lead immuno-dermatology by in-licensing IL-17C compound for atopic dermatitis

• Novartis enters an exclusive license agreement with Galapagos and MorphoSys for an investigational biologic compound, MOR106, a novel antibody directed against IL-17C

• IL-17C is believed to contribute significantly to atopic dermatitis (AD), a form of eczema and a severe dermatologic condition with high prevalence and significant unmet medical need [1],[2],[3]

• MOR106 is an extension of the Novartis AD pipeline portfolio, which includes oral ZPL389 in phase II, underlining Novartis commitment to immuno-dermatology

Basel, July 19, 2018 - Novartis announced today that it has entered into an exclusive license agreement with biotech companies Galapagos NV, Mechelen (Belgium) and MorphoSys AG, Planegg/Munich (Germany) regarding their compound MOR106. Under the agreement, Novartis acquires the exclusive global development and marketing rights to MOR106 for atopic dermatitis and all other potential indications. Novartis will make an upfront payment of EUR 95 million to Galapagos and MorphoSys, and additional payments, royalties and fees pending achievement of agreed milestones. The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

"We are a leader in immuno-dermatology and committed to reimagining the care of patients with severe diseases such as psoriasis, chronic spontaneous urticaria and atopic dermatitis. There is a key role for biologics to treat these severe diseases, which are more than just skin conditions, as they have complex underlying root causes," said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. "We are pleased to work with Galapagos and MorphoSys who have a proven track record of developing drug candidates for severe inflammatory diseases."

AD, a form of eczema, is a dermatologic disease that can cause intense itching and recurring lesions [1],[4]. AD affects approximately 8% of adults and 14% of children worldwide [4]. There is significant medical need for innovative treatments to help patients with this debilitating disease[4].

MOR106 is a monoclonal antibody directed against IL-17C. MOR106 is an extension of the Novartis AD portfolio, which includes oral ZPL389 in phase II. MOR106 has demonstrated first signs of efficacy and was generally safe and well tolerated in a double blind placebo-controlled Phase Ib study. MOR106 is a potentially first in class anti-IL-17C monoclonal antibody for AD and possibly other diseases. The in-licensing of MOR106 underlines Novartis commitment to lead immuno-dermatology, adding to Novartis marketed product portfolio Cosentyx and Xolair.

References

[1]     Weidinger, Stephan et al, Atopic dermatitis. Nature Reviews (2018) 4:1. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00149-X/abstract
[2]     Guttman-Yassky, Emma   and Krueger, James G. IL-17C: A Unique Epithelial Cytokine with Potential for Targeting across the Spectrum of Atopic Dermatitis and Psoriasis. Journal of Investigative Dermatology (2018) 138, 1467e1469.
[3]     Vandeghinste, Nick, Neutralization of IL-17C Reduces Skin Inflammation in Mouse Models of Psoriasis and Atopic Dermatitis, Journal of Investigative Dermatology (2018) 138, 1555e1563.
[4]     Silverberg, Jonathan I., Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin 35 (2017) 283-289.