Arrowhead Begins Triple Combination Cohort in Chronic HBV Patients and Earns $25 Million Milestone Payment from Janssen

PASADENA, CA, USA I April 24, 2019 I Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has begun dosing in a new triple combination cohort (cohort 12) that includes JNJ-3989 (formerly ARO-HBV) and additional undisclosed agents selected by Janssen Pharmaceuticals, Inc. in its ongoing Phase 1/2 study (AROHBV1001) in patients with chronic hepatitis B virus (HBV). In connection with the start of this new cohort, Arrowhead has earned a $25 million milestone payment from Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Christopher Anzalone, Ph.D., president and chief executive officer at Arrowhead, said: “Both Arrowhead and Janssen share the aim to advance transformational medicines that achieve higher rates of functional cure with a finite treatment duration for patients with chronic hepatitis B viral infection. Beginning this new triple combination cohort in our ongoing AROHBV1001 study has the potential to generate valuable data rapidly.”

AROHBV1001 (NCT03365947) is a Phase 1/2 clinical study evaluating the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, as well as the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.

Arrowhead entered into a license and collaboration agreement with Janssen in October 2018 to develop and commercialize ARO-HBV. Under the initial terms of the HBV license agreement, Arrowhead was eligible to receive a $50 million milestone payment linked to a Phase 2 study. Arrowhead and Janssen subsequently amended the HBV license agreement to accelerate the payment of $25 million of the $50 million Phase 2 milestone with the initiation of cohort 12 of the AROHBV1001 trial. Arrowhead is eligible to receive the remaining $25 million upon the initiation of a Phase 2 study by Janssen.

Hepatitis B infection is a life-threatening viral infection of the liver, which can cause cirrhosis — scarring of liver tissue — and liver cancer if the infection becomes chronic. The World Health Organization cites that hepatitis B is a global public health problem with 257 million people living with the disease, resulting in 887,000 deaths in 2015.1 While a preventive vaccine is available, cure rates for those infected remain low and most patients will endure lifelong therapy.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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1 World Health Organization (WHO). Hepatitis B. July 2017. Available at:

SOURCE: Arrowhead Pharmaceuticals

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