Policy & Regulation
Arrowhead Pharmaceuticals Enters Exclusive License Agreement with GSK for ARO-HSD
23 November 2021 - - US-based pharmaceutical company Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) has entered into an exclusive license agreement with UK-based GlaxoSmithKline (LSE: GSK) (NYSE: GSK) under which GSK will develop and commercialize ARO-HSD, Arrowhead's investigational RNA interference therapeutic in a Phase 1/2 trial that is currently being developed as a treatment for patients with nonalcoholic steatohepatitis, the company said.

Under the terms of the agreement, Arrowhead will receive an upfront payment of USD 120m and is eligible for additional payments of USD 30m at the start of Phase 2 and USD 100m upon achieving a successful Phase 2 trial readout and the first patient dosed in a Phase 3 trial.

Furthermore, should the Phase 3 trial read out positively, and the potential new medicine receives regulatory approval in major markets, the deal provides for commercial milestone payments to Arrowhead of up to USD 190m at first commercial sale, and up to USD 590m in sales-related milestone payments.

Arrowhead is further eligible to receive tiered royalties on net product sales.

GSK will receive an exclusive license to develop and commercialize ARO-HSD in all territories except Greater China, which will be retained by Arrowhead.

GSK will be wholly responsible for further clinical development and commercialization, outside of Greater China.

The transaction is expected to close in 1Q22, subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

ARO-HSD is an investigational RNAi therapeutic targeting HSD17B13 as a potential treatment for patients with alcohol-related and nonalcohol related liver diseases, such as NASH.

HSD17B13 is a member of the hydroxysteroid dehydrogenase family involved in the metabolism of hormones, fatty acids, and bile acids.

Published human genetic data indicate that a loss of function mutation in HSD17B13 provides strong protection against alcoholic hepatitis, cirrhosis, and NASH, with approximately 30-50% risk reduction compared to non-carriers.

ARO-HSD is being investigated in AROHSD1001 (NCT04202354), a Phase 1/2 single and multiple dose-escalating trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ARO-HSD in up to 74 normal healthy volunteers and patients with NASH or suspected NASH.

Additional exploratory objectives of AROHSD1001 include the assessment of various measures of drug activity using liver biopsy.
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