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
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Insights
The agreement between Arvinas and Novartis is a significant strategic move with substantial financial implications. The upfront payment of $150 million serves as an immediate cash infusion for Arvinas, which can bolster its balance sheet and fund ongoing research and development activities. The potential for additional milestones totaling up to $1.01 billion represents a sizeable future revenue stream, contingent on the successful development, regulatory approval and commercialization of ARV-766. The tiered royalties on sales further align Arvinas' long-term financial interests with the commercial success of the drug.
Investors should note the importance of the Hart-Scott-Rodino Antitrust Improvements Act in this context, as the deal's closure hinges on regulatory consents, which can impact the timing and certainty of the anticipated financial benefits. The involvement of Goldman Sachs as a financial advisor indicates a well-structured deal, potentially maximizing value for Arvinas shareholders. The transaction could lead to a reevaluation of Arvinas' stock, especially if the market perceives this partnership as an endorsement of Arvinas' technology platform and pipeline potential.
The licensing of ARV-766 and the sale of the AR-V7 program to Novartis is a pivotal development in the field of targeted protein degradation therapies. ARV-766, a second generation PROTAC® androgen receptor degrader, represents an innovative approach in treating prostate cancer. The collaboration with Novartis, a global pharmaceutical giant, is likely to accelerate the clinical development process due to Novartis' extensive resources and expertise in drug development and commercialization.
For stakeholders, the success of ARV-766 could mean a new, effective treatment option for prostate cancer, addressing a significant unmet medical need. The mention of ARV-766 as a potential first-in-class treatment indicates its novelty and possible competitive advantage in the oncology market. This partnership not only validates Arvinas' PROTAC platform but also could lead to broader applications of the technology, potentially opening up new therapeutic areas and revenue opportunities.
The strategic license agreement between Arvinas and Novartis marks a noteworthy event within the biotechnology sector, particularly in the niche of targeted protein degradation. The PROTAC® platform, which stands for PROteolysis TArgeting Chimeras, is at the forefront of drug design, offering a method to target and degrade disease-causing proteins. This technology has the potential to address a wide range of diseases, beyond prostate cancer, which could disrupt the current treatment landscape.
Arvinas' decision to partner with Novartis for the development and commercialization of ARV-766 can be seen as a strategic move to leverage Novartis' global reach and clinical development prowess. The transaction's potential to yield over a billion dollars in milestones, along with royalties, suggests a high level of confidence in the drug's market potential. For the broader industry, this deal may trigger similar collaborations, as big pharma companies seek to integrate innovative platforms like PROTAC® into their pipelines to stay competitive.
– Arvinas to receive a
– Novartis to be responsible for worldwide clinical development and commercialization of ARV-766 –
– Partnership expected to accelerate and broaden the development of ARV-766 as a potential first-in-class treatment option for patients with prostate cancer –
NEW HAVEN, Conn., April 11, 2024 (GLOBE NEWSWIRE) -- 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
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-766
ARV-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 Arvinas
Arvinas 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 Statements
This 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) 247-5089
Jeff.Boyle@arvinas.com
Media Contact:
Kathleen Murphy, Arvinas Communications
+1 (760) 622-3771
Kathleen.Murphy@arvinas.com
FAQ
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