WILMINGTON – Growing Wilmington-area biopharmaceutical firm Incyte has agreed to acquire a North Carolina-based firm working on a new treatment for the skin pigmentation disorder vitiligo in a deal worth up to $1.36 billion.
The deal announced Monday morning is a big bet by the growing Incyte, which secured the first U.S. Food & Drug Administration approval for a vitiligo treatment earlier this summer. In its research for new cancer drugs, Incyte researchers discovered that Jakafi, known generically as ruxolitinib, was effective in treating non-cancer, autoimmune diseases, including vitiligo and eczema. Last year, it won FDA approval for its Opzelura cream for eczema in some patients and gained approval for vitiligo in July.
It will now acquire Villaris Therapeutics, a biopharmaceutical company founded in Cary, N.C., three years ago by health care-focused investment firm Medicxi and led by Dr. John E. Harris, chair of dermatology at the University of Massachusetts Chan Medical School. Villaris is focused on the development of novel antibody therapeutics for vitiligo, a disease that causes skin to lose its color in patches that usually get bigger with time. It occurs when the cells that produce the pigment melanin die or stop functioning properly.
While it affects people of all skin types, it’s often most noticeable and stigmatizing in the Black community, where the patches are more visible. Although not life-threatening or contagious, there is no cure for vitiligo.
Villaris’ lead drug is auremolimab, a monoclonal antibody that is expected to enter clinical development in 2023. Under the terms of the agreement, Incyte will acquire Villaris and the exclusive global rights to develop and commercialize auremolimab for all uses, including in vitiligo and other autoimmune and inflammatory diseases.
In exchange, Incyte will make an upfront payment of $70 million, and Villaris shareholders will be eligible for up to $310 million upon achievement of certain development and regulatory milestones, as well as up to an additional $1.05 billion in commercial milestones on net sales of the product.
“This acquisition complements our current portfolio, providing us the opportunity to further enhance treatment options for people with vitiligo, leveraging the expertise we established in the dermatology space through our successful launch of Opzelura cream,” said Hervé Hoppenot, CEO of Incyte, in a statement announcing the deal. “People living with immune-mediated dermatologic diseases like vitiligo face significant challenges, and we are committed to developing novel therapies like auremolimab, which may address these unmet needs.”
The deal is a bet that vitiligo and other dermatological problems will become a large revenue driver for Incyte, which was first successful in addressing rare cancers and has rarely acquired other companies. There are more than 1.5 million patients diagnosed with vitiligo in the U.S., with upward of 200,000 currently actively seeking treatment without an FDA-approved drug, and another more than 2 million patients in Europe.
Harris said that he was excited to match his drug candidate with the resources of Incyte, which could help advance its trials and market any potential uses.
“I am really excited by the potential for auremolimab to treat vitiligo and other diseases with significant unmet need, and to see that it will now be driven forward with the capabilities and resources of Incyte. Back in 2019, I was very pleased to partner with Michèle Ollier and the Medicxi team to create Villaris as a single-purpose, asset-centric company with a laser focus on developing auremolimab for people with vitiligo who are in desperate need of better treatments. This next phase of development with Incyte will help to make that a reality,” he said in a statement.
The agreement is still subject to clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act and will become effective as soon as this condition has been met.