– Villaris shareholders to receive upfront
payment of $70 million, with potential for up to $1.36 billion in
additional milestone payments
– Pre-clinical data for auremolimab demonstrate
high potency, selectivity and efficacy in vitiligo
– Acquisition will complement Incyte’s existing
Inflammation and AutoImmunity portfolio with potential applications
for auremolimab beyond Dermatology
Incyte (NASDAQ:INCY) today announced that the Company has
entered into an agreement to acquire Villaris Therapeutics, an
asset-centric biopharmaceutical company seeded by Medicxi and
focused on the development of novel antibody therapeutics for
vitiligo. Its lead asset, auremolimab (VM6), an anti-IL-15Rβ
monoclonal antibody (mAb), is expected to enter clinical
development in 2023.
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the full release here:
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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. 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™
(ruxolitinib) Cream,” said Hervé Hoppenot, Chief Executive Officer,
Incyte. “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.”
John E. Harris, M.D., Ph.D., Professor and Chair of Dermatology
at the University of Massachusetts Chan Medical School and Founder
of Villaris, commented, “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.”
“Our mission at Medicxi is to partner with world-class
innovators like John Harris, who are developing novel treatments
for major unmet needs,” said Nick Williams, Partner at Medicxi.
“Auremolimab has the potential to transform the lives of people
living with vitiligo, and we are extremely excited to be partnering
with Incyte, a pioneering company in this indication with the
capabilities to explore the broader potential of auremolimab.”
The agreement is 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.
PJT Partners advised Villaris on the transaction.
About Auremolimab
Auremolimab (VM6) is a novel, ultra-humanized, anti-IL-15Rβ
(CD122) antibody designed to target and deplete autoreactive
resident memory T cells (TRM) that has demonstrated efficacy as a
treatment for vitiligo in preclinical models. IND-enabling studies
are currently underway, and clinical development is expected to
begin in 2023.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has
formed the foundation of the company. In Dermatology, the Company’s
research and development efforts are focused on leveraging our
knowledge of the JAK-STAT pathway to identify and develop topical
and oral therapies with the potential to modulate immune pathways
driving uncontrolled inflammation and help restore normal immune
function.
Currently, Incyte is exploring the potential of JAK inhibition
for additional immune-mediated dermatologic conditions with a high
unmet medical need, including hidradenitis suppurativa. To learn
more, visit the Dermatology section of Incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
About Villaris
Based in Cary, North Carolina, Villaris was founded in 2019 by
Medicxi and John Harris, M.D., Ph.D. to develop a potentially
transformational new treatment to improve the lives of people
living with vitiligo. Villaris is a paradigmatic example of
Medicxi’s asset-centric development model, which combines
world-class insights and experience with capital and expertise to
fully power the program from its initial design to its improvement
through ultra-humanization.
About Medicxi
Medicxi is a healthcare-focused investment firm with the mission
to create and invest in companies across the full drug development
continuum. Medicxi invests in early and late-stage therapeutics
with a product vision that can fulfill a clear unmet medical need.
Many of its portfolio companies have been acquired including:
Impact Biomedicines (acquired by Celgene); XO1 (acquired by Janssen
Pharmaceuticals); SynthorX (acquired by Sanofi); Miro Bio (acquired
by Gilead); and PanGenetics (acquired by Abbott). Several portfolio
companies are now publicly listed, including: GenMab (Copenhagen:
GEN.CO); Molecular Partners (SIX: MOLN); Vaxcyte (NASDAQ: PCVX);
Aura Biosciences (NASDAQ: AURA); and Centessa Pharmaceuticals
(NASDAQ: CNTA). For more information, please visit:
https://www.medicxi.com.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether and when auremolimab will be approved for use;
whether and when Incyte will bring auremolimab to market; the
potential of auremolimab to treat patients with vitiligo or for any
other indication; the potential for Villaris and its shareholders
to receive payments from Incyte for development, regulatory and
commercial milestones; and the potential for Incyte to broaden its
ability to bring new medicines to patients, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on the Company's
current expectations and are subject to risks and uncertainties
that may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; the effects of the COVID-19 pandemic and measures to
address the pandemic on the Company’s clinical trials, supply
chain, other third-party providers and development and discovery
operations; determinations made by regulatory authorities; the
Company’s dependence on its relationships with its collaboration
partners; the efficacy or safety of the Company’s products and the
products of the Company’s collaboration partners; the acceptance of
the Company’s products and the products of the Company’s
collaboration partners in the marketplace; market competition;
sales, marketing, manufacturing and distribution requirements; and
other risks detailed from time to time in the Company’s reports
filed with the Securities and Exchange Commission, including its
annual report and its quarterly report on Form 10-Q for the quarter
ended June 30, 2022. The Company disclaims any intent or obligation
to update these forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221003005269/en/
Incyte:
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
Medicxi:
Optimum Strategic Communications Mary Clark/Nick
Bastin/Manel Mateus +44 (0) 20 8148 3040
medicxi@optimumcomms.com
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