| |
Arrowhead Pharmaceuticals Enters Exclusive
License Agreement with GSK for ARO-HSD
|
| |
| |
Nov 22, 2021
- Upon closing, Arrowhead to receive $120 million upfront payment for Phase 1/2 program for NASH
- Arrowhead eligible to receive potential milestone payments and royalties on commercial sales
- GSK to receive an exclusive license for ARO-HSD in all territories except Greater China
PASADENA, Calif.--(BUSINESS WIRE)--Nov. 22, 2021-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it entered into an exclusive license agreement with GlaxoSmithKline (LSE/NYSE: GSK) under which GSK will develop and commercialize ARO-HSD, Arrowhead's investigational RNA interference (RNAi) therapeutic in a Phase 1/2 trial that is currently being developed as a treatment for patients with nonalcoholic steatohepatitis (NASH).
"Genetic studies have shown that HSD17B13 is a compelling therapeutic target for multiple forms of liver disease. Based on the clinical results generated to date, including those recently presented at the 2021 AASLD Liver Meeting, ARO-HSD could have the potential to be the first investigational therapeutic to achieve robust reductions in mRNA and protein levels of hepatic HSD17B13, leading to reductions in ALT, a liver enzyme typically elevated in liver diseases such as NASH," said Christopher Anzalone, Ph.D., Arrowhead's president and CEO. "GSK has a global reach and impressive capabilities in the clinical development and commercialization of important medicines. As the work continues towards progressing further Phase 2 studies and planning Phase 3 studies for ARO-HSD, we believe this agreement with GSK furthers the potential of ARO-HSD as a promising new investigational therapeutic for patients with NASH and other liver diseases. We look forward to enabling GSK to advance ARO-HSD towards the millions of patients worldwide who do not have adequate treatment options."
"NASH can be a life-threatening disorder in which excessive fat build-up in the liver causes inflammatory damage and fibrosis. The compelling genetic evidence linking HSD17B13 variants with protection of the liver from inflammatory injury suggests that there is an opportunity to produce a first-in-class medicine to reduce the clinical consequences of NASH. It's exciting to advance Arrowhead's promising RNAi approach into Phase 2 studies as an important potential new medicine for patients with NASH," said John Lepore, SVP and Head of Research, GSK.
Financial Terms
Under the terms of the agreement, Arrowhead will receive an upfront payment of $120 million and is eligible for additional payments of $30 million at the start of Phase 2 and $100 millionupon 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 $190 million at first commercial sale, and up to $590 million 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 the first quarter of 2022, subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
About ARO-HSD
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.1 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.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," or "continue" are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, 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.
________________
1 The New England Journal of Medicine. 2018, 1096-1106
View source version on businesswire.com:
https://www.businesswire.com/news/home/20211122006522/en/
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com
Media:
LifeSci Communications, LLC
Josephine Belluardo, Ph.D.
646-751-4361
jo@lifescicomms.com
www.lifescicommunications.com
Source: Arrowhead Pharmaceuticals, Inc
------------------------------------------
GSK ties up with Arrowhead to develop NASH drug candidate
Nov 22 (Reuters) - Arrowhead Pharmaceuticals Inc (ARWR.O) on Monday entered a drug development deal with GlaxoSmithKline Plc (GSK.L) under which the British drugmaker will develop and market Arrowhead's potential treatment for patients with fatty liver disease NASH.
Under the pact, Arrowhead said it would get an upfront payment of $120 million and is eligible for additional milestone payments including up to $190 million at first commercial sale of the product, and up to $590 million in sales-related milestone payments.
The drug candidate, ARO-HSD, is currently in an early-to-mid stage trial for nonalcoholic steatohepatitis (NASH), a fatty liver disease. It is based on RNA interference technology, where genes that contribute to disease are silenced.
GSK will receive an exclusive license to develop and sell ARO-HSD in all territories except Greater China, which will be retained by Arrowhead.
Glaxosmithkline plc (GSK) waded into the competitive nonalcoholic steatohepatitis (NASH) waters by way of an exclusive global licensing deal (excluding China) with Arrowhead Pharmaceuticals Inc., under which GSK will develop and commercialize ARO-HSD, Arrowhead's RNAi therapy targeting HSD17B13. The compound is undergoing a phase I/II trial. Arrowhead banks an up-front payment of $120 million and is eligible for $30 million at the start of phase II plus $100 million upon achieving a successful phase II trial readout along with dosing the first patient in a phase III experiment. If phase III results prove positive in NASH and ARO-HSD wins regulatory approval in major markets, Pasadena, Calif.-based Arrowhead would collect up to $190 million at the first commercial sale, and as much as $590 million in sales-related milestone payments, along with tiered royalties. Shares of the firm (NASDAQ:ARWR) were trading midday at $66.26, down $3.01.
---------------------
GSK Goes All-In on NASH in $1 Billion Arrowhead Pact
Published: Nov 23, 2021
GlaxoSmithKline has signed an exclusive license deal with Arrowhead Pharmaceuticals to develop and commercialize Arrowhead's investigational RNA interference (RNAi) drug to treat nonalcoholic steatohepatitis (NASH).
ARO-HSD, the RNAi in focus, will be evaluated in a Phase I/II trial that will assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of its ability to target HSD17B13 as a treatment for NASH. HSD17B13 is part of the hydroxysteroid dehydrogenase family that metabolizes fatty acids, hormones and bile acids. Loss of function mutation in this component has been observed to provide a strong shield against alcoholic cirrhosis, hepatitis and NASH. It has also demonstrated the ability to reduce the risk for the said diseases in non-carriers by 30% to 50%.
NASH is an advanced type of non-alcoholic fatty liver disease (NAFLD) that's caused by fat buildup in the liver that eventually leads to organ scarring. It is common in patients who are overweight or obese. To date, there is no standard of treatment for NASH but interventions to slow its progression involve drastic lifestyle changes such as losing weight and adopting a healthy diet. Unaddressed NASH that leads to scarring can lead to a deadly condition called cirrhosis.
Under the terms of the deal, GSK will pay $120 million to Arrowhead upfront. The latter will also be eligible for future payments amounting to $30 million when the Phase II trial starts and $100 million upon the successful completion of the Phase II study and when the first patient for Phase III has been dosed. If the Phase III trial delivers positive results, Arrowhead stands to gain as much as $190 million in additional payments at the first commercial sale and then another $590 million maximum in sales-related milestones hit.
In exchange, GSK will get to exclusively develop and commercialize ARO-HSD in all territories, except Greater China (which remains with Arrowhead). GSK will also be responsible for any further clinical development and commercialization globally.
"GSK has a global reach and impressive capabilities in the clinical development and commercialization of important medicines. As the work continues towards progressing further Phase 2 studies and planning Phase 3 studies for ARO-HSD, we believe this agreement with GSK furthers the potential of ARO-HSD as a promising new investigational therapeutic for patients with NASH and other liver diseases. We look forward to enabling GSK to advance ARO-HSD towards the millions of patients worldwide who do not have adequate treatment options," said Christopher Anzalone, Ph.D., the president and chief executive officer of Arrowhead, in a statement.
As of this writing, ARO-HSD is being investigated in a Phase I/II single and multiple-dose escalating trial involving 74 normal healthy volunteers and patients diagnosed with NASH or suspected to have NASH. Other exploratory objectives of the test include the use of liver biopsy to assess different measures of drug activity.
The transaction has yet to receive clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 but is expected to close by the first quarter of 2022.
Earlier this month, Arrowhead announced that it is entering a Phase I clinical study with Janssen Pharmaceuticals to explore a siRNA therapeutic called JNJ-75220795 also as a potential treatment for NASH. Under this arrangement, Janssen will use Arrowhead's TRIM platform.
| |
| |
| |
|
|
|
