Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor (AR) Protein Degrader ARV-766 for the Treatment of Prostate Cancer
11 Aprile 2024 - 1:00PM
Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology
company creating a new class of drugs based on targeted protein
degradation, today announced it has entered into an exclusive
strategic license agreement with Novartis (NYSE: NVS) for the
worldwide development and commercialization of ARV-766, Arvinas’
second generation PROTAC® androgen receptor (AR) degrader for
patients with prostate cancer. The transaction also includes an
asset purchase agreement for the sale of Arvinas’ preclinical AR-V7
program to Novartis.
“We are thrilled to partner with an organization that shares our
dedication to delivering transformative medicines to patients with
significant unmet need,” said John Houston, Ph.D., Chairperson,
President and Chief Executive Officer of Arvinas. “We believe the
expertise and scale of Novartis will broaden the development of
ARV-766 and its potential to be a first- and best-in-class
treatment for patients with prostate cancer. This strategic
transaction also further validates our innovative PROTAC protein
degrader platform and its potential to deliver new treatments.”
Under the terms of the transaction agreements, Novartis will be
responsible for worldwide clinical development and
commercialization of ARV-766 and will have all research,
development, manufacturing, and commercialization rights with
respect to the preclinical AR-V7 program. Arvinas will receive an
upfront payment in the aggregate amount of $150.0 million. Under
the License Agreement, Arvinas is eligible to receive additional
development, regulatory, and commercial milestones of up to $1.01
billion, as well as tiered royalties for ARV-766.
Closing of the transaction is subject to the parties’ receipt of
any necessary consents or approvals, including the expiration or
termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is
acting as the exclusive financial advisor to Arvinas.
About ARV-766ARV-766 is an investigational
orally bioavailable PROTAC® protein degrader designed to
selectively target and degrade the androgen receptor (AR).
Preclinically, ARV-766 has demonstrated activity in models of wild
type androgen receptor tumors in addition to tumors with AR
mutations or amplification, both common potential mechanisms of
resistance to currently available AR-targeted therapies.
About ArvinasArvinas is a clinical-stage
biotechnology company dedicated to improving the lives of patients
suffering from debilitating and life-threatening diseases through
the discovery, development, and commercialization of therapies that
degrade disease-causing proteins. Arvinas uses its proprietary
PROTAC® Discovery Engine platform to engineer proteolysis targeting
chimeras, or PROTAC® targeted protein degraders, that are designed
to harness the body’s own natural protein disposal system to
selectively and efficiently degrade and remove disease-causing
proteins. In addition to its robust preclinical pipeline of PROTAC
protein degraders against validated and “undruggable” targets, the
company has four investigational clinical-stage programs:
vepdegestrant (ARV-471) for the treatment of patients with locally
advanced or metastatic ER+/HER2- breast cancer; ARV-766 and
bavdegalutamide for the treatment of patients with metastatic
castration-resistant prostate cancer; and ARV-102 for the treatment
of patients with neurodegenerative disorders. For more information,
visit www.arvinas.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995 that involve
substantial risks and uncertainties, including statements regarding
the potential for ARV-766 to be a first- and best-in-class
treatment for patients with prostate cancer, the potential of
Arvinas’ PROTAC protein degrader platform and its potential to
deliver new treatments, the closing of the transaction with
Novartis, the receipt of upfront, milestone, and royalty payments
in connection with the transaction and the future development,
potential marketing approval and commercialization of ARV-766. All
statements, other than statements of historical fact, contained in
this press release, including statements regarding Arvinas’
strategy, future operations, future financial position, future
revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Arvinas may not actually achieve the plans, intentions or
expectations disclosed in these forward-looking statements, and you
should not place undue reliance on such forward-looking statements.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements Arvinas makes as a result of various risks and
uncertainties, including but not limited to: the satisfaction or
waiver of the closing conditions set forth in the license agreement
with Novartis, each party’s performance of its obligations under
the license agreement, whether Novartis will be able to
successfully conduct and complete clinical development, obtain
marketing approval for and commercialize ARV-766, and other
important factors discussed in the “Risk Factors” section of
Arvinas’ Annual Report on Form 10-K for the year ended December 31,
2023 and subsequent other reports on file with the U.S. Securities
and Exchange Commission. The forward-looking statements contained
in this press release reflect Arvinas’ current views with respect
to future events, and Arvinas assumes no obligation to update any
forward-looking statements, except as required by applicable law.
These forward-looking statements should not be relied upon as
representing Arvinas’ views as of any date subsequent to the date
of this release.
Arvinas Contacts
Investor Contact:Jeff Boyle, Arvinas Investor
Relations+1 (347) 247-5089Jeff.Boyle@arvinas.com
Media Contact:Kathleen Murphy, Arvinas
Communications+1 (760) 622-3771Kathleen.Murphy@arvinas.com
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