Arrowhead Pharmaceuticals and Novartis Announce Worldwide Licensing Deal for RNAi Therapeutics, Potential for Over $3 Billion in Payments
PASADENA, Calif. – October 26, 2023 – Arrowhead Pharmaceuticals, Inc. (ARWR) and Novartis (NVS) today announced a global license and collaboration agreement focused on developing and commercializing Arrowhead’s RNAi therapeutics. The partnership centers around Arrowhead’s investigational transthyretin (TTR) amyloidosis programme,ARO-XBU,and grants Novartis exclusive worldwide rights to develop,commercialize,and manufacture ARO-XBU.
The agreement provides Arrowhead with an upfront payment of $150 million and the potential to receive over $3 billion in milestone payments tied to achievement of pre-defined development and commercial milestones, as well as royalties on future net sales. TTR amyloidosis is a rare, progressive, and often fatal disease caused by misfolded TTR protein accumulating in various organs. This collaboration aims to accelerate the development and potential availability of a new treatment option for patients suffering from this condition.
“We are excited to partner with Novartis,a global leader in the development and commercialization of innovative medicines,to advance ARO-XBU for the treatment of TTR amyloidosis,” said Christopher Anzalone,President and CEO of Arrowhead Pharmaceuticals. “This collaboration validates our leading RNAi platform and our commitment to developing perhaps curative therapies for patients with significant unmet medical needs.”
Under the terms of the agreement, Novartis will assume obligation for the clinical development, manufacturing, and commercialization of ARO-XBU globally. Arrowhead will support the transition and continue to provide certain research services. The collaboration will leverage Arrowhead’s proprietary Targeted RNAi Delivery (TRD) platform to deliver RNAi therapeutics directly to the liver, silencing the production of the misfolded TTR protein.
“Novartis is committed to delivering innovative medicines for patients with rare diseases,” said Vasant Narasimhan, CEO of Novartis. “This collaboration with Arrowhead complements our existing pipeline and strengthens our position in the field of RNAi therapeutics, offering the potential to address a significant unmet need for patients with TTR amyloidosis.”
ARO-XBU is currently in Phase 1 clinical development. The companies anticipate initiating a Phase 2 clinical trial in the first half of 2024.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential benefits of the collaboration with Novartis, the development and commercialization of ARO-XBU, the timing of clinical trials, the potential for milestone payments and royalties, and the future success of Arrowhead’s scientific studies. Actual results may differ materially from those projected in these forward-looking statements due to a variety of factors,including decisions of regulatory authorities and the timing thereof,the duration and impact of regulatory delays in our clinical programs,our ability to finance our operations,the likelihood and timing of the receipt of future milestone and licensing fees,the future success of our scientific studies,our ability to successfully develop and commercialize drug candidates,the timing for starting and completing clinical trials,rapid technological change in our markets,the enforcement of our intellectual property rights,and the other risks and uncertainties described in our most recent Annual Report on Form 10-K,subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.
Source: Arrowhead pharmaceuticals, Inc.
Contacts:
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors:
LifeSci Advisors, LLC
Brian ritchie
212-915-2578
britchie@lifesciadvisors.com
Media:
LifeSci Communications,LLC
Kendy Guarinoni,Ph.D.
724-910-9389
kguarinoni@lifescicomms.com